Trial · NCT02660983
A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease
NCT02660983, Phase 4, Completed, Eisai Co., Ltd.; results first posted 2019-10-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease. Trials, record NCT02660983. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02660983
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease
- NCT number
- NCT02660983
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 302 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Dementia Associated With Cerebrovascular Disease
- Interventions
- Donepezil hydrochloride, Donepezil matching placebo, Donepezil hydrochloride
- First posted
- 2016-01-21
- Last updated
- 2020-01-10
- Results first posted
- 2019-10-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double Blind (DB) Phase: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score (LOCF) at Week 24 | Baseline and Week 24 | The ADAS-Cog was a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). The ADAS-cog scores range from 0 to 70, with negative change from baseline indicating clinical improvement. LOCF=last observation carried forward. |
| Primary | Double Blind (DB) Phase: Clinicians Interview-based Impression of Change-plus Caregiver Input (CIBIC-plus) Score (LOCF) | Week 24 | The CIBIC-plus rates change in global functioning relative to baseline on a scale. The score ranges from 1 (Marked improvement) to 7 (Marked worsening). A score of "4" represents no change from baseline. LOCF=last observation carried forward. |
| Secondary | Double Blind (DB) Phase: Change From Baseline in Mini-mental State Examination (MMSE) Score (LOCF) at Week 24 | Baseline and Week 24 | MMSE is a well-known, gold standard test for measuring the cognitive state of dementia participants. It includes items evaluating orientation to time and place, recall of objects, attention, language, and conversational abilities. The total score ranges from 0 (most impaired) to 30 (no impairment). The lower score means severe cognitive deficit. A positive change score indicated improvement from baseline. LOCF=last observation carried forward. |
| Secondary | Double Blind (DB) Phase: Change From Baseline in Executive Function Test (Korean Trail Making Test Elderly [K-TMT-e]) Score (LOCF) at Week 24 | Baseline and Week 24 | The trail making test (TMT) was an evaluation tool used to assess the cognitive function, especially for executive function. The K-TMT-e has two parts that are referred to as part A (component: serial numbers) and part B (component: serial numbers and days). The K-TMT-e was a timed test and the goal was to complete the tests accurately and as quickly as possible. Higher scores reveal greater impairment. K-TMT-e Score was measured as time taken by participants to complete goal. LOCF=last observation carried forward. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double Blind (DB) Phase: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score (LOCF) at Week 24 | Baseline and Week 24 | The FAS, LOCF, included all randomized participants who received at least one dose of study drug and had at least one postdose primary efficacy measurement. Overall number of participants analyzed included participants who were evaluable at a particular time point for this outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Double Blind (DB) Phase: Clinicians Interview-based Impression of Change-plus Caregiver Input (CIBIC-plus) Score (LOCF) | Week 24 | The FAS, LOCF, included all randomized participants who received at least one dose of study drug and had at least one postdose primary efficacy measurement. Overall number of participants analyzed included participants who were evaluable at a particular time point for this outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Double Blind (DB) Phase: Change From Baseline in Mini-mental State Examination (MMSE) Score (LOCF) at Week 24 | Baseline and Week 24 | The FAS, LOCF, included all randomized participants who received at least one dose of study drug and had at least one postdose primary efficacy measurement. Overall number of participants analyzed included participants who were evaluable at a particular time point for this outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Double Blind (DB) Phase: Change From Baseline in Executive Function Test (Korean Trail Making Test Elderly [K-TMT-e]) Score (LOCF) at Week 24 | Baseline and Week 24 | The FAS, LOCF, included all randomized participants who received at least one dose of study drug and had at least one postdose primary efficacy measurement. Number analyzed signifies participants who were evaluable at a particular part of study for this outcome measure. | seconds | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Double Blind (DB) Phase: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score (LOCF) at Week 24 | Double Blind (DB) Phase: Placebo | -2.06 | Standard Error 0.42 | score on a scale | |
| Double Blind (DB) Phase: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score (LOCF) at Week 24 | Double Blind (DB) Phase: Donepezil | -2.64 | Standard Error 0.44 | score on a scale | |
| Double Blind (DB) Phase: Clinicians Interview-based Impression of Change-plus Caregiver Input (CIBIC-plus) Score (LOCF) | Double Blind (DB) Phase: Placebo | 3.85 | Standard Error 0.07 | score on a scale | |
| Double Blind (DB) Phase: Clinicians Interview-based Impression of Change-plus Caregiver Input (CIBIC-plus) Score (LOCF) | Double Blind (DB) Phase: Donepezil | 3.73 | Standard Error 0.07 | score on a scale | |
| Double Blind (DB) Phase: Change From Baseline in Mini-mental State Examination (MMSE) Score (LOCF) at Week 24 | Double Blind (DB) Phase: Placebo | 0.59 | Standard Error 0.22 | score on a scale | |
| Double Blind (DB) Phase: Change From Baseline in Mini-mental State Examination (MMSE) Score (LOCF) at Week 24 | Double Blind (DB) Phase: Donepezil | 1.23 | Standard Error 0.22 | score on a scale | |
| Double Blind (DB) Phase: Change From Baseline in Executive Function Test (Korean Trail Making Test Elderly [K-TMT-e]) Score (LOCF) at Week 24 | Double Blind (DB) Phase: Placebo | Part A | -5.10 | Standard Error 4.38 | seconds |
| Double Blind (DB) Phase: Change From Baseline in Executive Function Test (Korean Trail Making Test Elderly [K-TMT-e]) Score (LOCF) at Week 24 | Double Blind (DB) Phase: Donepezil | Part A | -12.82 | Standard Error 4.52 | seconds |
| Double Blind (DB) Phase: Change From Baseline in Executive Function Test (Korean Trail Making Test Elderly [K-TMT-e]) Score (LOCF) at Week 24 | Double Blind (DB) Phase: Placebo | Part B | 1.16 | Standard Error 5.41 | seconds |
| Double Blind (DB) Phase: Change From Baseline in Executive Function Test (Korean Trail Making Test Elderly [K-TMT-e]) Score (LOCF) at Week 24 | Double Blind (DB) Phase: Donepezil | Part B | -13.73 | Standard Error 5.52 | seconds |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind (DB) Phase (24 Weeks) | STARTED | Placebo in DB Phase Then Donepezil in OLE Phase | 154 | |
| Double-blind (DB) Phase (24 Weeks) | STARTED | Donepezil in DB Phase Then Donepezil in OLE Phase | 148 | |
| Double-blind (DB) Phase (24 Weeks) | Treated/Safety Set | Placebo in DB Phase Then Donepezil in OLE Phase | 153 | |
| Double-blind (DB) Phase (24 Weeks) | Treated/Safety Set | Donepezil in DB Phase Then Donepezil in OLE Phase | 147 | |
| Double-blind (DB) Phase (24 Weeks) | COMPLETED | Placebo in DB Phase Then Donepezil in OLE Phase | 130 | |
| Double-blind (DB) Phase (24 Weeks) | COMPLETED | Donepezil in DB Phase Then Donepezil in OLE Phase | 122 | |
| Double-blind (DB) Phase (24 Weeks) | NOT COMPLETED | Placebo in DB Phase Then Donepezil in OLE Phase | 24 | |
| Double-blind (DB) Phase (24 Weeks) | NOT COMPLETED | Donepezil in DB Phase Then Donepezil in OLE Phase | 26 | |
| Open Label Extension Phase (24 Weeks) | STARTED | Placebo in DB Phase Then Donepezil in OLE Phase | 86 | |
| Open Label Extension Phase (24 Weeks) | STARTED | Donepezil in DB Phase Then Donepezil in OLE Phase | 75 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events702
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 | Thrombocytopenia | Blood and lymphatic system disorders | Double Blind (DB) Phase: Placebo | 1 | 153 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Double Blind (DB) Phase: Donepezil | 1 | 147 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Open Label Extension (OLE) Phase: Donepezil | 0 | 161 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Double Blind (DB) Phase: Placebo | 1 | 153 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Double Blind (DB) Phase: Donepezil | 0 | 147 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Open Label Extension (OLE) Phase: Donepezil | 0 | 161 | |
| other | Ventricular extrasystoles | Cardiac disorders | Double Blind (DB) Phase: Placebo | 0 | 153 | |
| other | Ventricular extrasystoles | Cardiac disorders | Double Blind (DB) Phase: Donepezil | 1 | 147 | |
| other | Ventricular extrasystoles | Cardiac disorders | Open Label Extension (OLE) Phase: Donepezil | 0 | 161 | |
| other | Atrial fibrillation | Cardiac disorders | Double Blind (DB) Phase: Placebo | 1 | 153 |
1 to 10 of 702Source ClinicalTrials.gov
See all 702 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double Blind (DB) Phase: Placebo | 1 | 153 |
| Total, all-cause mortality | Double Blind (DB) Phase: Donepezil | 1 | 147 |
| Total, all-cause mortality | Open Label Extension (OLE) Phase: Donepezil | 2 | 161 |
| Total, other adverse events | Double Blind (DB) Phase: Placebo | 73 | 153 |
| Total, other adverse events | Double Blind (DB) Phase: Donepezil | 86 | 147 |
| Total, other adverse events | Open Label Extension (OLE) Phase: Donepezil | 63 | 161 |
| Total, serious adverse events | Double Blind (DB) Phase: Placebo | 24 | 153 |
| Total, serious adverse events | Double Blind (DB) Phase: Donepezil | 18 | 147 |
| Total, serious adverse events | Open Label Extension (OLE) Phase: Donepezil | 12 | 161 |
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.
Tests2
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 | Source |
|---|---|---|
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | 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/NCT02660983
GET https://conductscience.org/api/trials/v1/NCT02660983/events?page=2