Trial Outcomes & Findings for Memantine and Comprehensive, Individualized Management of Alzheimer's Disease and Caregiver Training (NCT NCT00120874)
NCT ID: NCT00120874
Last Updated: 2016-10-25
Results Overview
CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse
COMPLETED
PHASE4
20 participants
Baseline to 28 weeks
2016-10-25
Participant Flow
Participant milestones
| Measure |
Memantine + CIPCM Program
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
Completed Study; Started Extension Study
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Memantine + CIPCM Program
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Memantine and Comprehensive, Individualized Management of Alzheimer's Disease and Caregiver Training
Baseline characteristics by cohort
| Measure |
Individualized Management and Memantine
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine
n=10 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Total
n=20 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
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic-American
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White, not of Hispanic-American Origin
|
10 participants
n=99 Participants
|
8 participants
n=107 Participants
|
18 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 28 weeksCIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)
|
2.3 units on a scale
Standard Deviation 1.16
|
5.22 units on a scale
Standard Deviation 1.56
|
PRIMARY outcome
Timeframe: Baseline to 52 weeksCIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)
|
2.1 units on a scale
Standard Deviation 1.45
|
6 units on a scale
Standard Deviation 1.32
|
PRIMARY outcome
Timeframe: Baseline to 28 weeksThe ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)
|
21.9 units on a scale
Standard Deviation 8.034
|
9.6 units on a scale
Standard Deviation 6.041
|
PRIMARY outcome
Timeframe: Baseline to 52 weeksThe ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)
|
18.5 units on a scale
Standard Deviation 8.045
|
7.6 units on a scale
Standard Deviation 6.766
|
SECONDARY outcome
Timeframe: Baseline to 28 weeksThe SIB evaluates cognitive performance. It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction. Scores range from 0 (greatest impairment) to 100 (least impairment).
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline of the Severe Impairment Battery (SIB)
|
51.3 units on a scale
Standard Deviation 33.843
|
54 units on a scale
Standard Deviation 37.002
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksThe SIB evaluates cognitive performance. It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction. Scores range from 0 (greatest impairment) to 100 (least impairment).
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline of the Severe Impairment Battery (SIB)
|
45.1 units on a scale
Standard Deviation 33.365
|
48 units on a scale
Standard Deviation 37.353
|
SECONDARY outcome
Timeframe: Baseline to 28 weeksThe MMSE is a graded on a 30 point scale that measures cognitive functioning. A lower score indicates a higher level of impairment. Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline of the Mini-Mental State Examination (MMSE)
|
6.7 units on a scale
Standard Deviation 5.143
|
8.4 units on a scale
Standard Deviation 5.816
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksThe MMSE is a graded on a 30 point scale that measures cognitive functioning. A lower score indicates a higher level of impairment. Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline of the Mini-Mental State Examination (MMSE)
|
6.7 units on a scale
Standard Deviation 4.138
|
6.7 units on a scale
Standard Deviation 5.477
|
SECONDARY outcome
Timeframe: Baseline to 28 weeksThe FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2. The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)
|
6.16 units on a scale
Standard Deviation 0.631
|
6.67 units on a scale
Standard Deviation 0.246
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksThe FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2. The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)
|
6.5 units on a scale
Standard Deviation 0.254
|
6.84 units on a scale
Standard Deviation 0.279
|
SECONDARY outcome
Timeframe: Baseline to 28 weeksThe BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating. Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed. Possible total scores range from 0 to 297. The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver). Global rating was not analyzed for this study. The higher the score the worse the outcome.
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)
|
7.2 units on a scale
Standard Deviation 5.308
|
23.7 units on a scale
Standard Deviation 14.952
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksThe BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating. Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed. Possible total scores range from 0 to 297. The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver). The higher the score the worse the outcome.
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)
|
8.1 units on a scale
Standard Deviation 5.131
|
21.2 units on a scale
Standard Deviation 11.893
|
SECONDARY outcome
Timeframe: Baseline to 28 weeksThe RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96.
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency
|
24.7 units on a scale
Standard Deviation 9.945
|
34.9 units on a scale
Standard Deviation 9.515
|
SECONDARY outcome
Timeframe: Baseline to 28 weeksThe RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96.
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction
|
2.0 units on a scale
Standard Deviation 2.582
|
10.7 units on a scale
Standard Deviation 14.143
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksThe RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96.
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency
|
24.4 units on a scale
Standard Deviation 8.449
|
32.4 units on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksThe RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96.
Outcome measures
| Measure |
Memantine + CIPCM Program
n=10 Participants
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine Alone
n=9 Participants
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction
|
3.8 units on a scale
Standard Deviation 6.68
|
11.4 units on a scale
Standard Deviation 11.599
|
Adverse Events
Individualized Management and Memantine
Memantine
Serious adverse events
| Measure |
Individualized Management and Memantine
n=10 participants at risk
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine
n=10 participants at risk
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Left Hip fracture
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Fall
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Diarrhea
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Left heel Ulcer
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Left heel Infection
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Left Pelvic Fracture
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Stage II Pressure Ulcer
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Urinary tract Infection
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Dehydration
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Cardiopulmonary Arrest
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Atherosclerotic Heart Disease
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Syncope
|
0.00%
0/10
|
20.0%
2/10 • Number of events 4
|
Other adverse events
| Measure |
Individualized Management and Memantine
n=10 participants at risk
Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
Memantine
n=10 participants at risk
Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily.
|
|---|---|---|
|
Investigations
abnormal blood results
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
red blotch on face
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Dizziness
|
10.0%
1/10 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
4/10 • Number of events 4
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Diarrhea
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 2
|
|
Infections and infestations
Fungal skin rash in groin
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
toenail fungal infection
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10
|
10.0%
1/10 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Calcified bone mass on hip due to muscle tear
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Investigations
abnormal urine analysis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Vitamin D insufficiency
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Nervous system disorders
Rigidity
|
0.00%
0/10
|
20.0%
2/10 • Number of events 2
|
|
Nervous system disorders
Abnormal sensation in hands
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Endocrine disorders
Increasing hypothyroidism
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Increased alkaline phosphatase
|
0.00%
0/10
|
20.0%
2/10 • Number of events 3
|
|
Blood and lymphatic system disorders
Elevated Platelet Count
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Black blister on Left heel
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10
|
40.0%
4/10 • Number of events 4
|
|
General disorders
Brown liquid coming from nose
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Sleepiness
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Decreased appetite
|
0.00%
0/10
|
10.0%
1/10 • Number of events 2
|
|
General disorders
Electrolyte abnormality
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing Loss
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Increased leg edema
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
0.00%
0/10
|
20.0%
2/10 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Stage I Pressure Sore
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Dehydration
|
0.00%
0/10
|
10.0%
1/10 • Number of events 2
|
|
General disorders
Hypotension
|
0.00%
0/10
|
10.0%
1/10 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Fall
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bruised ribs
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Buttocks abscess
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Buttocks ulcer
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Elevated creatinine and decreased GFR
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Hypoglycemia
|
0.00%
0/10
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Elevated C Reactive Protein
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Investigations
mild hypercholesterolemia
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Adipsia
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Lost ability to walk
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Lip smacking and chomping
|
0.00%
0/10
|
10.0%
1/10 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin tear
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Abrasion
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place