Trial · NCT00174382
Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
NCT00174382, Phase 3, Terminated, Pfizer; results first posted 2009-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia. Trials, record NCT00174382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00174382
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
- NCT number
- NCT00174382
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 149 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Dementia, Vascular, Dementia, Mixed
- Interventions
- Donepezil
- First posted
- 2005-09-15
- Last updated
- 2015-03-24
- Results first posted
- 2009-06-12
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set | Baseline, week 12, week 24 | 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. |
| Secondary | Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain. | Baseline, week 12, week 24 | 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. |
| Secondary | Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain. | Baseline, 12 weeks, 24 weeks | 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 |
| Secondary | Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS) | Baseline, week 12, week 24 | DAD total score equals total number of questions answered yes multiplied by 100 divided by total number of questions answered. |
| Secondary | Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS) | Baseline, 12 weeks, 24 weeks | 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. |
| Secondary | Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS) | Baseline, 12 weeks, 24 weeks | 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. |
| Secondary | CLOX Differential Score Change From Baseline; Full Analysis Set (FAS) | Baseline, 12 weeks, 24 weeks | 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. |
| Secondary | Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS) | Baseline, 12 weeks, week 24 | The number of words a particpant can generate in 1 minute. |
| Secondary | Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS) | Baseline, 12 weeks, 24 weeks | 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 |
| Secondary | Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS) | Baseline, week 12, week 24 | 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 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set | Baseline, week 12, week 24 | 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 | Score on a scale | MEAN |
| SECONDARY | Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain. | Baseline, week 12, week 24 | 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. | score on a scale | MEAN |
| SECONDARY | Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain. | Baseline, 12 weeks, 24 weeks | 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 | score on a scale | MEAN |
| SECONDARY | Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS) | Baseline, week 12, week 24 | 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 | score on a scale | MEAN |
| SECONDARY | Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS) | Baseline, 12 weeks, 24 weeks | 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 | Score on a scale | MEAN |
| SECONDARY | Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS) | Baseline, 12 weeks, 24 weeks | 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 | Score on scale | MEAN |
| SECONDARY | CLOX Differential Score Change From Baseline; Full Analysis Set (FAS) | Baseline, 12 weeks, 24 weeks | 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 | Score on a scale | MEAN |
| SECONDARY | Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS) | Baseline, 12 weeks, week 24 | 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 | score on scale | MEAN |
| SECONDARY | Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS) | Baseline, 12 weeks, 24 weeks | 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 | Score on scale | MEAN |
| SECONDARY | Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS) | Baseline, week 12, week 24 | 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 | Score on a scale | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set | Donepezil | Week 12 (n=124) | 0.41 | Standard Deviation 3.10 | Score on a scale |
| Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set | Donepezil | Week 24 (n=114) | 0.69 | Standard Deviation 3.2 | Score on a scale |
| Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set | Donepezil | Week 24 LOCF (n=137) | 0.48 | Standard Deviation 3.25 | Score on a scale |
| Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain. | Donepezil | week 12 (n=124) | 1.68 | Standard Deviation 13.23 | score on a scale |
| Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain. | Donepezil | week 24 (n=114) | -1.61 | Standard Deviation 19.68 | score on a scale |
| Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain. | Donepezil | week 24 LOCF (n=137) | -1.88 | Standard Deviation 18.15 | score on a scale |
| Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain. | Donepezil | week 12 (n=124) | 1.68 | Standard Deviation 18.01 | score on a scale |
| Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain. | Donepezil | week 24 (n=114) | 0.20 | Standard Deviation 22.37 | score on a scale |
| Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain. | Donepezil | week 24 LOCF (n=137) | 1.31 | Standard Deviation 22.30 | score on a scale |
| Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS) | Donepezil | week 12 (n=124) | 1.71 | Standard Deviation 13.18 | score on a scale |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Donepezil | 149 | |
| Overall Study | COMPLETED | Donepezil | 116 | |
| Overall Study | NOT COMPLETED | Donepezil | 33 |
Source ClinicalTrials.gov
Adverse events33
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Donepezil | 15 | 148 | |
| other | Nausea | Gastrointestinal disorders | Donepezil | 26 | 148 | |
| other | Vomiting | Gastrointestinal disorders | Donepezil | 9 | 148 | |
| other | Anorexia | Metabolism and nutrition disorders | Donepezil | 8 | 148 | |
| other | Dizziness | Nervous system disorders | Donepezil | 11 | 148 | |
| other | Headache | Nervous system disorders | Donepezil | 8 | 148 | |
| other | Insomnia | Psychiatric disorders | Donepezil | 15 | 148 | |
| serious | Cardiac failure congestive | Cardiac disorders | Donepezil | 1 | 148 | |
| serious | Myocardial infarction | Cardiac disorders | Donepezil | 2 | 148 | |
| serious | Sick sinus syndrome | Cardiac disorders | Donepezil | 1 | 148 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Donepezil | ||
| Total, other adverse events | Donepezil | 53 | |
| Total, serious adverse events | Donepezil | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Clock Drawing Task | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00174382
GET https://conductscience.org/api/trials/v1/NCT00174382/results?page=2