Trial Outcomes & Findings for Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia (NCT NCT00174382)
NCT ID: NCT00174382
Last Updated: 2015-03-24
Results Overview
Change from baseline in sMMSE total score. Change: mean total score at observation minus mean total score at baseline. Total score is derived by adding all subscores and ranges from 0 to 30; a higher score indicates a better cognitive state.
TERMINATED
PHASE3
149 participants
Baseline, week 12, week 24
2015-03-24
Participant Flow
Study was conducted in Canada in 30 centres.
Participant milestones
| Measure |
Donepezil
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Overall Study
STARTED
|
149
|
|
Overall Study
COMPLETED
|
116
|
|
Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
| Measure |
Donepezil
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
19
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Arrived early for last visit in error
|
1
|
|
Overall Study
Subject felt pill not effective enough
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
Baseline characteristics by cohort
| Measure |
Donepezil
n=149 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Age, Customized
< 45
|
0 Participants
n=5 Participants
|
|
Age, Customized
45-64
|
20 Participants
n=5 Participants
|
|
Age, Customized
>= 65
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 12, week 24Population: Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. N=137; Weeks 12, 24 n=124, 114
Change from baseline in sMMSE total score. Change: mean total score at observation minus mean total score at baseline. Total score is derived by adding all subscores and ranges from 0 to 30; a higher score indicates a better cognitive state.
Outcome measures
| Measure |
Donepezil
n=137 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set
Week 12 (n=124)
|
0.41 Score on a scale
Standard Deviation 3.10
|
|
Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set
Week 24 (n=114)
|
0.69 Score on a scale
Standard Deviation 3.2
|
|
Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set
Week 24 LOCF (n=137)
|
0.48 Score on a scale
Standard Deviation 3.25
|
SECONDARY outcome
Timeframe: Baseline, week 12, week 24Population: Full Analysis Set (FAS): all subjects who received at least one dose of donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n= 124, 114.
The ADL domain includes 17 yes/no questions on four items (hygiene, dressing, continence, eating). Score equals number of questions answered yes multiplied by 100 divided by number of questions answered. Change: Mean ADL score at observation minus mean ADL score at baseline.
Outcome measures
| Measure |
Donepezil
n=137 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.
week 12 (n=124)
|
1.68 score on a scale
Standard Deviation 13.23
|
|
Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.
week 24 (n=114)
|
-1.61 score on a scale
Standard Deviation 19.68
|
|
Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.
week 24 LOCF (n=137)
|
-1.88 score on a scale
Standard Deviation 18.15
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n= 124,114
IADL domain consists of 23 yes-no questions on 6 items (meal preparation, telephoning, going out, finance \& correspondence, medications, leisure \& housework. Change: Mean IADL score at observation minus mean IADL score at baseline. Total IADL score = number of questions answered yes multiplied by 100 divided by total number of questions answered
Outcome measures
| Measure |
Donepezil
n=137 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.
week 12 (n=124)
|
1.68 score on a scale
Standard Deviation 18.01
|
|
Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.
week 24 (n=114)
|
0.20 score on a scale
Standard Deviation 22.37
|
|
Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.
week 24 LOCF (n=137)
|
1.31 score on a scale
Standard Deviation 22.30
|
SECONDARY outcome
Timeframe: Baseline, week 12, week 24Population: Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n = 124, 114
DAD total score equals total number of questions answered yes multiplied by 100 divided by total number of questions answered.
Outcome measures
| Measure |
Donepezil
n=137 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)
week 12 (n=124)
|
1.71 score on a scale
Standard Deviation 13.18
|
|
Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)
week 24 (n=114)
|
-0.12 score on a scale
Standard Deviation 18.01
|
|
Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)
week 24 LOCF (n=137)
|
0.17 score on a scale
Standard Deviation 17.01
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. N=137; weeks 12, 24 n = 123, 111
The ability to draw a clock free-hand. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 1 score at observation minus mean CLOX score at baseline.
Outcome measures
| Measure |
Donepezil
n=137 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)
Week 12 (n=123)
|
-0.03 Score on a scale
Standard Deviation 3.08
|
|
Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)
Week 24 (n=111)
|
0.95 Score on a scale
Standard Deviation 3.13
|
|
Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)
Week LOCF (n=137)
|
0.74 Score on a scale
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF N=131; weeks 12, 24 n = 117, 106
The ability to copy a drawing of a clock. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 2 score at observation minus mean CLOX 2 score at baseline.
Outcome measures
| Measure |
Donepezil
n=131 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)
week 12 (n=117)
|
0.28 Score on scale
Standard Deviation 3.35
|
|
Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)
week 24 (n=106)
|
0.84 Score on scale
Standard Deviation 2.92
|
|
Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)
week 24 LOCF (n=131)
|
0.51 Score on scale
Standard Deviation 3.09
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.LOCF N=131; weeks 12, 24 n = 117, 106
CLOX differential score equals the difference between the score for CLOX 2 and the score for CLOX 1, values range from 15 to 0, with 0 indicating perfect executive function, and a worsening with the increasing score.
Outcome measures
| Measure |
Donepezil
n=131 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)
week 12 (n=117)
|
0.26 Score on a scale
Standard Deviation 3.50
|
|
CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)
week 24 (n=106)
|
-0.35 Score on a scale
Standard Deviation 3.31
|
|
CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)
week 24 LOCF (n=131)
|
-0.44 Score on a scale
Standard Deviation 3.36
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, week 24Population: Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF n=136; weeks 12, 24 n = 123, 113
The number of words a particpant can generate in 1 minute.
Outcome measures
| Measure |
Donepezil
n=136 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)
week 12 (n=123)
|
0.84 score on scale
Standard Deviation 2.85
|
|
Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)
week 24 (n=113)
|
0.92 score on scale
Standard Deviation 3.38
|
|
Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)
week 24 LOCF (n=136)
|
0.83 score on scale
Standard Deviation 3.29
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF n=137; weeks 12, 24 n = 124, 114
NPI-Q measures severity of behavioural manifestations of dementia \& the level of distress each symptom gives the main caregiver, 1 (mild), 3 (severe), 0 if symptom absent, NPI-Q also measures the caregiver distress associated with each symptom,0(no distress)to 5(very severe), total score equals sum of individual item scores \& ranges from 0 to 36
Outcome measures
| Measure |
Donepezil
n=137 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)
week 12 (n=124)
|
-1.06 Score on scale
Standard Deviation 4.02
|
|
Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)
week 24 (n=114)
|
-1.20 Score on scale
Standard Deviation 4.19
|
|
Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)
week 24 LOCF (n=137)
|
-1.19 Score on scale
Standard Deviation 4.03
|
SECONDARY outcome
Timeframe: Baseline, week 12, week 24Population: Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.LOCF n=137; weeks 12, 24 n = 124, 114
The total NPI-Q-D score is equal to the sum of all indiviudal symptom distress scale scores with a range of 0 to 60
Outcome measures
| Measure |
Donepezil
n=137 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)
week 12 (n=124)
|
-0.95 Score on a scale
Standard Deviation 5.54
|
|
Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)
week 24 (n=114)
|
-1.37 Score on a scale
Standard Deviation 6.25
|
|
Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)
week 24 LOCF (n=137)
|
-1.08 Score on a scale
Standard Deviation 6.04
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. Subjects with Baseline = 136; week 24 n = 116; week 24 LOCF n = 136
Scale measures subject's clinical condition at baseline for severity (CGI-S) \& for improvement from baseline (CGI-I). At baseline subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill). At follow up subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) \& 4 indicates no change from baseline
Outcome measures
| Measure |
Donepezil
n=136 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)
Baseline (n=136)
|
3.40 Score on a scale
Standard Deviation 0.67
|
|
Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)
Week 24 (n=116)
|
3.32 Score on a scale
Standard Deviation 1.21
|
|
Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)
Week 24 LOCF (n=136)
|
3.40 Score on a scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. n=number of subjects with a value
Scale measures subject's clinical condition at baseline for severity (CGI-S) subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill).
Outcome measures
| Measure |
Donepezil
n=136 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Clinical Global Impressions Severity (CGI-S)
Normal, not at all ill (n=136)
|
2 Participants
|
|
Clinical Global Impressions Severity (CGI-S)
Borderline mentally ill (n=136)
|
4 Participants
|
|
Clinical Global Impressions Severity (CGI-S)
Mildly ill (n=136)
|
72 Participants
|
|
Clinical Global Impressions Severity (CGI-S)
Moderately ill (n=136)
|
54 Participants
|
|
Clinical Global Impressions Severity (CGI-S)
Markedly ill (n=136)
|
4 Participants
|
|
Clinical Global Impressions Severity (CGI-S)
Severely ill (n=136)
|
0 Participants
|
|
Clinical Global Impressions Severity (CGI-S)
Among the most extremely ill patients (n=136)
|
0 Participants
|
SECONDARY outcome
Timeframe: Week (wk) 24Population: Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. n=number of subjects with value (Week 24 n=116; Week 24 LOCF n=136)
Scale measures subject's clinical condition for improvement from baseline (CGI-I)subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) \& 4 indicates no change from baseline
Outcome measures
| Measure |
Donepezil
n=136 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Clinical Global Impressions Improvement (CGI-I)
Wk 24 Very much improved (n=116)
|
3 Participants
|
|
Clinical Global Impressions Improvement (CGI-I)
Wk 24 Much improved (n=116)
|
27 Participants
|
|
Clinical Global Impressions Improvement (CGI-I)
Wk 24 Minimally improved (n=116)
|
44 Participants
|
|
Clinical Global Impressions Improvement (CGI-I)
Wk 24 No change (n=116)
|
21 Participants
|
|
Clinical Global Impressions Improvement (CGI-I)
Wk 24 Minimally worse (n=116)
|
14 Participants
|
|
Clinical Global Impressions Improvement (CGI-I)
Wk 24 Much worse (n=116)
|
7 Participants
|
|
Clinical Global Impressions Improvement (CGI-I)
Wk 24 Very much worse (n=116)
|
0 Participants
|
|
Clinical Global Impressions Improvement (CGI-I)
Wk 24 LOCF Very much improved (n=136)
|
4 Participants
|
|
Clinical Global Impressions Improvement (CGI-I)
Wk 24 LOCF Much improved (n=136)
|
27 Participants
|
|
Clinical Global Impressions Improvement (CGI-I)
Wk 24 LOCF Minimally improved (n=136)
|
49 Participants
|
|
Clinical Global Impressions Improvement (CGI-I)
Wk 24 LOCF No change (n=136)
|
30 Participants
|
|
Clinical Global Impressions Improvement (CGI-I)
Wk 24 LOCF Minimally worse (n=136)
|
19 Participants
|
|
Clinical Global Impressions Improvement (CGI-I)
Wk 24 LOCF Much worse (n=136)
|
7 Participants
|
|
Clinical Global Impressions Improvement (CGI-I)
Wk 24 LOCF Very much worse (n=136)
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy. LOCF = Last Observation Carried Forward. Week 24 n=116; Week 24 LOCF n=136
Scale measures subject's (CGI-I) rated on categorial 7 point Likert scale 1 (very much improved) to 7 (very much worse) with 4 indicating no change from baseline. A dichotomized variable was created: responder = CGI-I score of 4 or less; non-responder = CGI-I score of 5 or more
Outcome measures
| Measure |
Donepezil
n=136 Participants
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Clinical Global Impressions Improvement (CGI-I) Dichotomized Response
Week 24 Responder (n=116)
|
95 Particpants
|
|
Clinical Global Impressions Improvement (CGI-I) Dichotomized Response
Week 24 Non-responder (n=116)
|
21 Particpants
|
|
Clinical Global Impressions Improvement (CGI-I) Dichotomized Response
Week 24 LOCF Responder (n=136)
|
110 Particpants
|
|
Clinical Global Impressions Improvement (CGI-I) Dichotomized Response
Week 24 LOCF Non-responder (n=136)
|
26 Particpants
|
Adverse Events
Donepezil
Serious adverse events
| Measure |
Donepezil
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.68%
1/148
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
2/148
|
|
Cardiac disorders
Sick sinus syndrome
|
0.68%
1/148
|
|
Gastrointestinal disorders
Abdominal pain
|
0.68%
1/148
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.68%
1/148
|
|
General disorders
Chest pain
|
1.4%
2/148
|
|
General disorders
General physical health deterioration
|
0.68%
1/148
|
|
Infections and infestations
Labyrinthitis
|
0.68%
1/148
|
|
Infections and infestations
Pneumonia
|
0.68%
1/148
|
|
Infections and infestations
Pyelonephritis
|
0.68%
1/148
|
|
Infections and infestations
Urosepsis
|
1.4%
2/148
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Fall
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.68%
1/148
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.0%
3/148
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.68%
1/148
|
|
Investigations
Electrocardiogram QT prolonged
|
0.68%
1/148
|
|
Metabolism and nutrition disorders
Anorexia
|
0.68%
1/148
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.68%
1/148
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.68%
1/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.68%
1/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.68%
1/148
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.68%
1/148
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
2/148
|
|
Psychiatric disorders
Confusional state
|
0.68%
1/148
|
|
Psychiatric disorders
Hallucination
|
0.68%
1/148
|
Other adverse events
| Measure |
Donepezil
Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.1%
15/148
|
|
Gastrointestinal disorders
Nausea
|
17.6%
26/148
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
9/148
|
|
Metabolism and nutrition disorders
Anorexia
|
5.4%
8/148
|
|
Nervous system disorders
Dizziness
|
7.4%
11/148
|
|
Nervous system disorders
Headache
|
5.4%
8/148
|
|
Psychiatric disorders
Insomnia
|
10.1%
15/148
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \<12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER