← Trials/Trial dossier/NCT00174382

TerminatedPhase 3Results posted

Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia

An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia

Lead sponsor

Pfizer

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

149

actual

Study population

Vascular cognitive impairment / dementia, Mixed / unspecified dementia

Key I/E criteria

•Multiple dementia etiologies•Study partner/caregiver required

Primary endpoint

•Mini-Mental State Examination (MMSE)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDA2501026

NCT IDNCT00174382

Timeline

Milestones

Study start2005-06 (month precision)

Study first posted2005-09-15estimated

Primary completion2008-04actual (month precision)

Study completion2008-04actual (month precision)

Results first posted2009-06-12estimated

Last update posted2015-03-24estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Vascular cognitive impairment / dementiaMixed / unspecified dementia

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subjects must meet DSM-IV-TR criteria for the clinical diagnosis of Vascular Dementia or the clinical diagnosis of dementia due to multiple etiologies.

•Subjects must have a reliable caregiver or family member who agrees to accompany the subject to all scheduled visits, provide information about the subject as required

Exclusion criteria

•Subjects with any current primary psychiatric diagnosis other than dementia of the Alzheimer's type or Vascular Dementia.

Endpoints (28)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Function / daily living

Behavior / neuropsychiatric

Global cognition

Executive function / language

Global cognition

2 endpoints

Primary/protocol endpoint

Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set

Time frame:Baseline, week 12, week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/registry result

Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set

Time frame:Baseline, week 12, week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
DonepezilWeek 12 (n=124)n=137 Participants	0.41	3.10
Week 24 (n=114)n=137 Participants	0.69	3.2
Week 24 LOCF (n=137)n=137 Participants	0.48	3.25

Mean Difference (Net)0.4495% CI-0.21 - 1.09p0.182Mixed Models Analysis

Mean Difference (Net)0.6695% CI-0.05 - 1.36p0.067Mixed Models Analysis

p0.085Mixed Models Analysis

Executive function / language

2 endpoints

Secondary/protocol endpoint

CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)

Time frame:Baseline, 12 weeks, 24 weeks

change from baseline, improvement

Secondary/registry result

CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)

Time frame:Baseline, 12 weeks, 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
Donepezilweek 12 (n=117)n=131 Participants	0.26	3.50
week 24 (n=106)n=131 Participants	-0.35	3.31
week 24 LOCF (n=131)n=131 Participants	-0.44	3.36

Mean Difference (Net)0.2195% CI-0.44 - 0.86p0.516Mixed Models Analysis

Mean Difference (Net)-0.3495% CI-0.97 - 0.30p0.297Mixed Models Analysis

p0.133Mixed Models Analysis

Function / daily living

6 endpoints

Secondary/protocol endpoint

Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.

Time frame:Baseline, week 12, week 24

change from baseline, improvement

Secondary/protocol endpoint

Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.

Time frame:Baseline, 12 weeks, 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)

Time frame:Baseline, week 12, week 24

change from baseline, improvement

Secondary/registry result

Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.

Time frame:Baseline, week 12, week 24

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Donepezilweek 12 (n=124)n=137 Participants	1.68	13.23
week 24 (n=114)n=137 Participants	-1.61	19.68
week 24 LOCF (n=137)n=137 Participants	-1.88	18.15

Mean Difference (Net)2.095% CI-1.20 - 5.19p0.218Mixed Models Analysis

Median Difference (Net)-1.8595% CI-6.03 - 2.34p0.385Mixed Models Analysis

p0.228Mixed Models Analysis

Secondary/registry result

Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.

Time frame:Baseline, 12 weeks, 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Donepezilweek 12 (n=124)n=137 Participants	1.68	18.01
week 24 (n=114)n=137 Participants	0.20	22.37
week 24 LOCF (n=137)n=137 Participants	1.31	22.30

Mean Difference (Net)1.8495% CI-2.51 - 6.18p0.404Mixed Models Analysis

Mean Difference (Net)0.5795% CI-4.51 - 5.64p0.826Mixed Models Analysis

p0.494Mixed Models Analysis

Secondary/registry result

Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)

Time frame:Baseline, week 12, week 24

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Donepezilweek 12 (n=124)n=137 Participants	1.71	13.18
week 24 (n=114)n=137 Participants	-0.12	18.01
week 24 LOCF (n=137)n=137 Participants	0.17	17.01

Mean Difference (Net)1.7895% CI-1.42 - 4.99p0.272Mixed Models Analysis

Mean Difference (Net)-0.2795% CI-4.21 - 3.68p0.894Mixed Models Analysis

p0.906Mixed Models Analysis

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)

Time frame:Baseline, 12 weeks, 24 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)

Time frame:Baseline, week 12, week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)

Time frame:Baseline, 12 weeks, 24 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Score on scale	Standard deviation
Donepezilweek 12 (n=124)n=137 Participants	-1.06	4.02
week 24 (n=114)n=137 Participants	-1.20	4.19
week 24 LOCF (n=137)n=137 Participants	-1.19	4.03

Mean Difference (Net)-1.1095% CI-1.93 - -0.27p0.010Mixed Models Analysis

Mean Difference (Net)-1.1295% CI-2.05 - -0.19p0.018Mixed Models Analysis

p0.018Mixed Models Analysis

Secondary/registry result

Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)

Time frame:Baseline, week 12, week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
Donepezilweek 12 (n=124)n=137 Participants	-0.95	5.54
week 24 (n=114)n=137 Participants	-1.37	6.25
week 24 LOCF (n=137)n=137 Participants	-1.08	6.04

Mean Difference (Net)-0.8395% CI-2.06 - 0.39p0.182Mixed Models Analysis

Mean Difference (Net)-1.0995% CI-2.44 - 0.26p0.114Mixed Models Analysis

p0.038Mixed Models Analysis

Other (unclassified)

14 endpoints

Secondary/protocol endpoint/low confidence

Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)

Time frame:Baseline, 12 weeks, 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)

Time frame:Baseline, 12 weeks, 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)

Time frame:Baseline, 12 weeks, week 24

event count, event

Secondary/protocol endpoint/low confidence

Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)

Time frame:Baseline, week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Clinical Global Impressions Severity (CGI-S)

Time frame:Baseline

descriptive

Secondary/protocol endpoint/low confidence

Clinical Global Impressions Improvement (CGI-I)

Time frame:Week (wk) 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Clinical Global Impressions Improvement (CGI-I) Dichotomized Response

Time frame:Baseline, week 24

change from baseline, improvement

Secondary/registry result/low confidence

Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)

Time frame:Baseline, 12 weeks, 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
DonepezilWeek 12 (n=123)n=137 Participants	-0.03	3.08
Week 24 (n=111)n=137 Participants	0.95	3.13
Week LOCF (n=137)n=137 Participants	0.74	3.13

Mean Difference (Net)0.1395% CI-0.56 - 0.82p0.719Mixed Models Analysis

Median Difference (Net)1.0095% CI0.29 - 1.71p0.006Mixed Models Analysis

p0.007Mixed Models Analysis

Secondary/registry result/low confidence

Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)

Time frame:Baseline, 12 weeks, 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Score on scale	Standard deviation
Donepezilweek 12 (n=117)n=131 Participants	0.28	3.35
week 24 (n=106)n=131 Participants	0.84	2.92
week 24 LOCF (n=131)n=131 Participants	0.51	3.09

Mean Difference (Net)0.3295% CI-0.38 - 1.01p0.368Mixed Models Analysis

Mean Difference (Net)0.7295% CI0.07 - 1.37p0.030Mixed Models Analysis

p0.060Mixed Models Analysis

Secondary/registry result/low confidence

Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)

Time frame:Baseline, 12 weeks, week 24

event count, event

Posted result

Group	Value (mean), score on scale	Standard deviation
Donepezilweek 12 (n=123)n=136 Participants	0.84	2.85
week 24 (n=113)n=136 Participants	0.92	3.38
week 24 LOCF (n=136)n=136 Participants	0.83	3.29

Median Difference (Net)0.7995% CI0.13 - 1.45p0.020Mixed Models Analysis

Median Difference (Net)0.8795% CI0.16 - 1.59p0.018Mixed Models Analysis

p0.004Mixed Models Analysis

Secondary/registry result/low confidence

Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)

Time frame:Baseline, week 24

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
DonepezilBaseline (n=136)n=136 Participants	3.40	0.67
Week 24 (n=116)n=136 Participants	3.32	1.21
Week 24 LOCF (n=136)n=136 Participants	3.40	1.19

Secondary/registry result/low confidence

Clinical Global Impressions Severity (CGI-S)

Time frame:Baseline

descriptive

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilNormal, not at all ill (n=136)n=136 Participants	2	-
Borderline mentally ill (n=136)n=136 Participants	4	-
Mildly ill (n=136)n=136 Participants	72	-
Moderately ill (n=136)n=136 Participants	54	-
Markedly ill (n=136)n=136 Participants	4	-
Severely ill (n=136)n=136 Participants	0	-
Among the most extremely ill patients (n=136)n=136 Participants	0	-

Secondary/registry result/low confidence

Clinical Global Impressions Improvement (CGI-I)

Time frame:Week (wk) 24

change from baseline, improvement

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilWk 24 Very much improved (n=116)n=136 Participants	3	-
Wk 24 Much improved (n=116)n=136 Participants	27	-
Wk 24 Minimally improved (n=116)n=136 Participants	44	-
Wk 24 No change (n=116)n=136 Participants	21	-
Wk 24 Minimally worse (n=116)n=136 Participants	14	-
Wk 24 Much worse (n=116)n=136 Participants	7	-
Wk 24 Very much worse (n=116)n=136 Participants	0	-
Wk 24 LOCF Very much improved (n=136)n=136 Participants	4	-
Wk 24 LOCF Much improved (n=136)n=136 Participants	27	-
Wk 24 LOCF Minimally improved (n=136)n=136 Participants	49	-
Wk 24 LOCF No change (n=136)n=136 Participants	30	-
Wk 24 LOCF Minimally worse (n=136)n=136 Participants	19	-
Wk 24 LOCF Much worse (n=136)n=136 Participants	7	-
Wk 24 LOCF Very much worse (n=136)n=136 Participants	0	-

Secondary/registry result/low confidence

Clinical Global Impressions Improvement (CGI-I) Dichotomized Response

Time frame:Baseline, week 24

change from baseline, improvement

Posted result

Group	Value (number), Particpants	Reported bounds
DonepezilWeek 24 Responder (n=116)n=136 Participants	95	-
Week 24 Non-responder (n=116)n=136 Participants	21	-
Week 24 LOCF Responder (n=136)n=136 Participants	110	-
Week 24 LOCF Non-responder (n=136)n=136 Participants	26	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.