Trial Outcomes & Findings for Comparative Study to Test Safety and Efficacy of Neurotrophic and Cholinergic Treatment of Alzheimer's Disease (NCT NCT00911807)
NCT ID: NCT00911807
Last Updated: 2009-06-10
Results Overview
The ADAS-cog+ is a validated, widely used, 14 item psychometric instrument for testing cognitive functions with increased sensitivity in detecting changes in milder patients compared to the original ADAS-cog. It has a maximum score of 85 with a higher score indicating impairment and was assessed by a qualified neuropsychologist.
COMPLETED
PHASE2
217 participants
baseline and week 28
2009-06-10
Participant Flow
Dates of recruitment period: 18-OCT-2004 - 29-OCT-2007 Type of location: hospital (La Coruna), institutions specialized on cognitive disorders (Granada, Malaga)
Patients were excluded from the trial before assignment to groups when not all inclusion criteria were met or when exclusion criteria were applicable.
Participant milestones
| Measure |
Cerebrolysin + Donepezil
|
Cerebrolysin
|
Donepezil
|
|---|---|---|---|
|
Overall Study
STARTED
|
72
|
70
|
75
|
|
Overall Study
COMPLETED
|
55
|
52
|
52
|
|
Overall Study
NOT COMPLETED
|
17
|
18
|
23
|
Reasons for withdrawal
| Measure |
Cerebrolysin + Donepezil
|
Cerebrolysin
|
Donepezil
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
5
|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
6
|
4
|
9
|
|
Overall Study
Withdrawal by Subject
|
8
|
10
|
7
|
|
Overall Study
Organizational reasons
|
1
|
3
|
1
|
Baseline Characteristics
Comparative Study to Test Safety and Efficacy of Neurotrophic and Cholinergic Treatment of Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Cerebrolysin + Donepezil
n=72 Participants
|
Cerebrolysin
n=70 Participants
|
Donepezil
n=75 Participants
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0.0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
24.0 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
63 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
193.0 Participants
n=7 Participants
|
|
Age Continuous
|
74.5 years
STANDARD_DEVIATION 8.3 • n=99 Participants
|
75.1 years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
76.0 years
STANDARD_DEVIATION 7.7 • n=206 Participants
|
75.2 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
169.0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
48.0 Participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
72 participants
n=99 Participants
|
70 participants
n=107 Participants
|
75 participants
n=206 Participants
|
217.0 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: baseline and week 28Population: Analysis was intention to treat
The ADAS-cog+ is a validated, widely used, 14 item psychometric instrument for testing cognitive functions with increased sensitivity in detecting changes in milder patients compared to the original ADAS-cog. It has a maximum score of 85 with a higher score indicating impairment and was assessed by a qualified neuropsychologist.
Outcome measures
| Measure |
Cerebrolysin + Donepezil
n=67 Participants
|
Cerebrolysin
n=64 Participants
|
Donepezil
n=66 Participants
|
|---|---|---|---|
|
Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive Subpart (Extended Version) (ADAS-COG+) at Week 28
|
-2.348 points on a scale
Standard Deviation 5.993
|
-1.711 points on a scale
Standard Deviation 7.500
|
-1.246 points on a scale
Standard Deviation 6.147
|
PRIMARY outcome
Timeframe: week 28Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 4, 12, 16Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 4, 12, 16, 28Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 4, 12, 16, 28Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 4, 12, 16Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 4, 12, 16, 28Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 28Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 16, 28Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 16, 28Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 4, 12, 16, 28Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 4, 12, 16, 28Outcome measures
Outcome data not reported
Adverse Events
Cerebrolysin + Donepezil
Cerebrolysin
Donepezil
Serious adverse events
| Measure |
Cerebrolysin + Donepezil
|
Cerebrolysin
|
Donepezil
|
|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/67
|
1.5%
1/65 • Number of events 1
|
0.00%
0/68
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/67
|
1.5%
1/65 • Number of events 1
|
0.00%
0/68
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/67
|
0.00%
0/65
|
1.5%
1/68 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/67
|
0.00%
0/65
|
1.5%
1/68 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
1.5%
1/67 • Number of events 1
|
0.00%
0/65
|
0.00%
0/68
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/67 • Number of events 1
|
0.00%
0/65
|
0.00%
0/68
|
Other adverse events
| Measure |
Cerebrolysin + Donepezil
|
Cerebrolysin
|
Donepezil
|
|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
7.5%
5/67 • Number of events 5
|
7.7%
5/65 • Number of events 5
|
10.3%
7/68 • Number of events 7
|
|
Psychiatric disorders
Agitation
|
6.0%
4/67 • Number of events 4
|
13.8%
9/65 • Number of events 9
|
4.4%
3/68 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
10.4%
7/67 • Number of events 7
|
9.2%
6/65 • Number of events 6
|
2.9%
2/68 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
4/67 • Number of events 4
|
7.7%
5/65 • Number of events 5
|
8.8%
6/68 • Number of events 6
|
|
Psychiatric disorders
Dysthymic disorder
|
10.4%
7/67 • Number of events 7
|
4.6%
3/65 • Number of events 3
|
5.9%
4/68 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
5/67 • Number of events 5
|
3.1%
2/65 • Number of events 2
|
8.8%
6/68 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia
|
6.0%
4/67 • Number of events 4
|
7.7%
5/65 • Number of events 5
|
4.4%
3/68 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
4.5%
3/67 • Number of events 3
|
4.6%
3/65 • Number of events 3
|
8.8%
6/68 • Number of events 6
|
|
Psychiatric disorders
Confusional state
|
4.5%
3/67 • Number of events 3
|
7.7%
5/65 • Number of events 5
|
5.9%
4/68 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
7.5%
5/67 • Number of events 5
|
1.5%
1/65 • Number of events 1
|
8.8%
6/68 • Number of events 6
|
|
Nervous system disorders
Headache
|
7.5%
5/67 • Number of events 5
|
6.2%
4/65 • Number of events 4
|
2.9%
2/68 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
4.5%
3/67 • Number of events 3
|
7.7%
5/65 • Number of events 5
|
4.4%
3/68 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
6.0%
4/67 • Number of events 4
|
6.2%
4/65 • Number of events 4
|
4.4%
3/68 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place