Trial Outcomes & Findings for Observational Study Of Donepezil In Routine Clinical Practice (NCT NCT00843115)
NCT ID: NCT00843115
Last Updated: 2014-03-13
Results Overview
Cognitive Activation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
TERMINATED
370 participants
Baseline and Week 12
2014-03-13
Participant Flow
This was a non interventional study conducted at 62 sites in Canada.
Subjects had a diagnosis of mild to moderate Alzheimer's Disease with or without other etiologies of dementia.
Participant milestones
| Measure |
Donepezil
As per physician prescription
|
|---|---|
|
Overall Study
STARTED
|
370
|
|
Overall Study
COMPLETED
|
304
|
|
Overall Study
NOT COMPLETED
|
66
|
Reasons for withdrawal
| Measure |
Donepezil
As per physician prescription
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Adverse Event
|
30
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
17
|
|
Overall Study
Family wanted meds stopped
|
1
|
|
Overall Study
Family does not want continuation
|
1
|
|
Overall Study
Patient forgot to take meds
|
1
|
|
Overall Study
Does not meet entrance criteria
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Family discontinued meds
|
1
|
|
Overall Study
patient took for 2 days then stopped
|
1
|
|
Overall Study
patient never took the medication
|
1
|
|
Overall Study
hospitalized due to deterioration
|
1
|
|
Overall Study
week 12 not done
|
1
|
|
Overall Study
Syndrome De Glissement
|
1
|
Baseline Characteristics
Observational Study Of Donepezil In Routine Clinical Practice
Baseline characteristics by cohort
| Measure |
Donepezil
n=370 Participants
As per physician prescription
|
|---|---|
|
Age, Continuous
|
80.1 years
STANDARD_DEVIATION 7.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
198 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis.
Cognitive Activation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
196 participants
|
|
All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
36 participants
|
|
All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
90 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT) : All subjects who did not have a response for post baseline assessment were not included in analysis.
Attention symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline and Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
202 Participants
|
|
All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
31 Participants
|
|
All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
89 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Repetitiveness symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
195 Participants
|
|
All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
32 Participants
|
|
All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
95 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Remembering symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
231 participants
|
|
All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
44 participants
|
|
All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
47 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Temporal Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
209 Participants
|
|
All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
39 Participants
|
|
All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
74 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Asphasia symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
190 participants
|
|
All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
28 participants
|
|
All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
104 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Spatial Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to categories: Improved/Stabilized=4,5,6; Worsened=2,3
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
201 participants
|
|
All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
25 participants
|
|
All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
96 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Judgment symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
206 participants
|
|
All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
30 participants
|
|
All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
86 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Insight symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
209 participants
|
|
All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
34 participants
|
|
All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
79 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Leisure symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
205 participants
|
|
All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
28 participants
|
|
All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
89 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Domestic Activities symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
198 participants
|
|
All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
23 participants
|
|
All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
101 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Hygiene symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
23 participants
|
|
All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
131 participants
|
|
All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
168 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Dressing symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
152 participants
|
|
All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
23 participants
|
|
All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
147 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Telephoning symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
190 participants
|
|
All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
16 participants
|
|
All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
116 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Agitation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
157 participants
|
|
All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
23 participants
|
|
All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
142 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Mood symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
187 participants
|
|
All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
38 participants
|
|
All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
97 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Anxiety symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
195 participants
|
|
All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
37 participants
|
|
All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
90 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Delusions symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
139 participants
|
|
All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
16 participants
|
|
All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
167 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Apathy symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
187 participants
|
|
All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
27 participants
|
|
All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
108 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Caregiver symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
213 participants
|
|
All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
30 participants
|
|
All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
79 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Severity symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline \& Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Improved or Stabilized
|
233 participants
|
|
All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Worsened
|
40 participants
|
|
All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Missing/Not Applicable
|
49 participants
|
SECONDARY outcome
Timeframe: baseline, Week 12Population: Intent to Treat (ITT): (n=288; number of subjects responding)
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12
|
1.1 score on scale
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: baseline, Week 12 LOCFPopulation: Intent to Treat (ITT) LOCF: (n=318; number of subjects responding)
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Last Observation Carried Forward (LOCF) Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12
|
1.1 score on scale
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: baseline, 12 WeeksPopulation: Intent to Treat (ITT); n=207 (number of subjects who responded)
MMSE cognitive function: Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole using scale: 1 (poor) - 4 (excellent), possible total 13 - 52. Separate ratings from both patient and caregiver.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Correlation Between Change From Baseline in Mini-Mental State Examination (MMSE) Score and Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score
|
0.33 Pearson Product Correlation Coefficient
|
SECONDARY outcome
Timeframe: baseline, Week 12 LOCFPopulation: Intent to Treat (ITT) LOCF: (n=231; number of subjects responding).
MMSE cognitive function. Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Correlation Between LOCF Change From Baseline in Mini-Mental State Examination (MMSE) Score and LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score
|
0.35 Pearson Product Correlation Coefficient
|
SECONDARY outcome
Timeframe: baseline, 12 WeeksPopulation: Intent to Treat (ITT). (n= 207; number of subjects who responded)
Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores
|
1.4 score on scale
Standard Deviation 3.36
|
SECONDARY outcome
Timeframe: baseline, 12 Week LOCFPopulation: Intent to Treat (ITT)LOCF: (n=231; number of subjects responding)
Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores
|
1.4 score on scale
Standard Deviation 3.44
|
SECONDARY outcome
Timeframe: baseline, 12 WeeksPopulation: Intent to Treat (ITT). (n=207 number of subjects responding)
QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Patient and the caregiver totals combined and correlated to number of treatment emergent adverse events.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Correlation Analysis: Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease(QoL-AD) Questionnaire Total Score Versus Number of Treatment Emergent Adverse Events (TEAEs)
|
-0.13 Pearson Product Correlation Coefficient
|
SECONDARY outcome
Timeframe: baseline, 12 Weeks LOCFPopulation: Intent to Treat (ITT) LOCF: (n=231; number of patients responding)
QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Ratings from patient and the caregiver combined and correlated with number of treatment emergent adverse events.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Correlation Analysis: LOCF Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease (QoL-AD) Questionnaire Total Score Versus the Number of Treatment Emergent Adverse Events (TEAEs)
|
-0.15 Pearson Product Correlation Coefficient
|
SECONDARY outcome
Timeframe: baseline, 12 WeeksPopulation: Intent to Treat (ITT) (n=290; number of subjects responding)
EQoL-5D: measures index of health and defines it in 5 Domains:mobility,self-care,usual activities, pain/discomfort, anxiety/depression. Each domain evaluated on 3-point scale yielding 243 potential combinations; converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change: Week 12 mean score minus baseline mean score
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)
|
0.015 score on scale
Standard Deviation 0.1071
|
SECONDARY outcome
Timeframe: baseline, 12 Weeks LOCFPopulation: Intent to Treat (ITT) LOCF: (n=321; number of subjects responding)
EQoL-5D: measures index of health \& defines it in 5 Domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each evaluated on 3-point scale yielding 243 potential combinations converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change:Week 12 mean score minus baseline mean score
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)
|
0.013 score on scale
Standard Deviation 0.1053
|
SECONDARY outcome
Timeframe: baseline, 12 WeeksPopulation: Intent to Treat (ITT): (n=286; number of subjects responding).
EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire
|
3.7 score on scale
Standard Deviation 10.55
|
SECONDARY outcome
Timeframe: baseline, 12 Weeks LOCFPopulation: Intent to Treat (ITT)LOCF: (n=318; number of subjects responding).
EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
LOCF Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire
|
3.1 score on scale
Standard Deviation 10.91
|
SECONDARY outcome
Timeframe: baseline, 12 WeeksPopulation: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health \& defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Change From Baseline in Subject's Mobility at Week 12
Any Problem
|
129 participants
|
|
Change From Baseline in Subject's Mobility at Week 12
No Problem
|
161 participants
|
SECONDARY outcome
Timeframe: Week 12 LOCFPopulation: Intent to Treat (ITT) LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health \& defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the proportion of subjects with "any problem" at baseline versus Week 12 LOCF
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Change From Baseline in Subject's Mobility at Week 12 LOCF
Any Problem
|
147 Participants
|
|
Change From Baseline in Subject's Mobility at Week 12 LOCF
No Problem
|
174 Participants
|
SECONDARY outcome
Timeframe: baseline, Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health \& defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Change From Baseline in Subject's Self-Care at Week 12
No Problem
|
168 participants
|
|
Change From Baseline in Subject's Self-Care at Week 12
Any Problem
|
122 participants
|
SECONDARY outcome
Timeframe: baseline, 12 Weeks LOCFPopulation: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health \& defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12 LOCF.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Change From Baseline in Subject's Self-Care at Week 12 LOCF
Any Problem
|
140 Participants
|
|
Change From Baseline in Subject's Self-Care at Week 12 LOCF
No Problem
|
181 Participants
|
SECONDARY outcome
Timeframe: baseline, Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health \& defines health in 5 Domains, including usual activities(no problem, some problem, unable to perform). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Change From Baseline in Subject's Usual Activities at Week 12
Any Problem
|
181 Participants
|
|
Change From Baseline in Subject's Usual Activities at Week 12
No Problem
|
109 Participants
|
SECONDARY outcome
Timeframe: baseline, 12 Weeks LOCFPopulation: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health \& defines health in 5 Domains, including usual activities (no problem, some problem, unable to perform). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12 LOCF
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Change From Baseline in Subject's Usual Activities at Week 12 LOCF
Any Problem
|
203 Participants
|
|
Change From Baseline in Subject's Usual Activities at Week 12 LOCF
No Problem
|
118 Participants
|
SECONDARY outcome
Timeframe: baseline, Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health \& defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Change From Baseline in Subject's Pain/Discomfort at Week 12
Any Problem
|
147 Participants
|
|
Change From Baseline in Subject's Pain/Discomfort at Week 12
No Problem
|
143 Participants
|
SECONDARY outcome
Timeframe: Week 12 LOCFPopulation: Intent to Treat (ITT)LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health \& defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the proportion of subjects with "any problem" at baseline versus Week 12 LOCF
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF
Any Problem
|
162 Participants
|
|
Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF
No Problem
|
159 Participants
|
SECONDARY outcome
Timeframe: baseline, Week 12Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health \& defines health in 5 Domains, including anxiety/depression(none, moderate or extreme anxiety/depression). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12.
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Change From Baseline in Subject's Anxiety/Depression at Week 12
Any Problem
|
158 Participants
|
|
Change From Baseline in Subject's Anxiety/Depression at Week 12
No Problem
|
132 Participants
|
SECONDARY outcome
Timeframe: baseline, Week 12 LOCFPopulation: Intent to Treat (ITT)LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health \& defines health in 5 Domains, including anxiety/depression (none, moderate or extreme anxiety/depression). Analysis of difference between the proportion of subjects with "any problem" and "no problem" at baseline versus at Week 12 LOCF
Outcome measures
| Measure |
Donepezil
n=322 Participants
As per physician prescription
|
|---|---|
|
Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF
Any Problem
|
179 Participants
|
|
Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF
No Problem
|
142 Participants
|
Adverse Events
Donepezil
Serious adverse events
| Measure |
Donepezil
As per physician prescription
|
|---|---|
|
General disorders
Death
|
1.1%
4/370
|
|
Cardiac disorders
Bradycardia
|
0.27%
1/370
|
|
Gastrointestinal disorders
Diverticulum
|
0.27%
1/370
|
|
Hepatobiliary disorders
Cholecystitis
|
0.27%
1/370
|
|
Infections and infestations
Diverticulitis
|
0.27%
1/370
|
|
Infections and infestations
Lobar Pneumonia
|
0.27%
1/370
|
|
Infections and infestations
Pneumonia
|
0.27%
1/370
|
|
Infections and infestations
Urinary Tract Infection
|
0.27%
1/370
|
|
Infections and infestations
Urosepsis
|
0.27%
1/370
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.27%
1/370
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.27%
1/370
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Maglinant
|
0.27%
1/370
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.27%
1/370
|
|
Nervous system disorders
Syncope
|
0.27%
1/370
|
Other adverse events
| Measure |
Donepezil
As per physician prescription
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
13/370
|
|
Gastrointestinal disorders
Nausea
|
5.9%
22/370
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
12/370
|
|
General disorders
Asthenia
|
2.2%
8/370
|
|
Nervous system disorders
Headache
|
3.5%
13/370
|
|
Psychiatric disorders
Insomnia
|
2.4%
9/370
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER