CompletedResults posted

Non-Interventional Study With Aricept® Evess

Non-Interventional Study With Aricept® Evess In Patients Diagnosed With Mild And Moderate Alzheimer's Disease Or Vascular Dementia

Lead sponsor

Pfizer

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

370

actual

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia

Key I/E criteria

•Multiple dementia etiologies•MMSE 12-24

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 IDA2501065

NCT IDNCT00889603

Timeline

Milestones

Study first posted2009-04-29estimated

Study start2009-05 (month precision)

Primary completion2010-03actual (month precision)

Study completion2010-03actual (month precision)

Last update posted2011-03-31estimated

Results first posted2011-03-31estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Outpatients (male / female), older than 50 years.

•Patients with clinical symptoms of mild and moderate AD and Vascular Dementia.

•MMSE score between 12 - 24

Exclusion criteria

•Patients with a known hypersensitivity to donepezil clorhydrat, piperidine derivatives or any of the excipients of Aricept® Evess.

•Patients with severe impaired hepatic function.

•Patients with pre-existing gastrointestinal ulcer disease.

•Patients with the history of bronchial asthma or chronic obstructive lung disease.

•Patients with the history of serious atrioventricular conduction disturbances.

Endpoints (20)

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 clinical outcomes

Global cognition

Function / daily living

Behavior / neuropsychiatric

Safety / tolerability / PK

Other (unclassified)

Global cognition

4 endpoints

Primary/protocol endpoint

Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)

Time frame:Baseline and Week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/registry result

Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)

Time frame:Baseline and Week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard error
Donepeziln=351 Participants	1.92	0.14

Mean Difference (Net)1.9295% CI1.65 - 2.20

Secondary/protocol endpoint

Change From Baseline in MMSE Total

Time frame:Baseline, Week 8, 16, and 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline in MMSE Total

Time frame:Baseline, Week 8, 16, and 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Scores on a scale	Standard error
DonepezilWeek 8 (N=348)n=348 Participants	0.92	0.09
Week 16 (N=340)n=348 Participants	1.56	0.12
Week 24 (N=327)n=348 Participants	1.97	0.14

Mean Difference (Final Values)0.9295% CI0.75 - 1.08

Mean Difference (Final Values)1.5695% CI1.32 - 1.80

Mean Difference (Final Values)1.9795% CI1.69 - 2.25

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Functional Activity Questionnaire (FAQ)

Time frame:Baseline and Week 24

change from baseline, improvement

Secondary/registry result

Change From Baseline in Functional Activity Questionnaire (FAQ)

Time frame:Baseline and Week 24

change from baseline, improvement

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Number of Participants in Each Patient Domain of Benefit

Time frame:Week 24

event count, event

Secondary/registry result

Number of Participants in Each Patient Domain of Benefit

Time frame:Week 24

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilCognitionn=335 Participants	202	-
Functionalityn=335 Participants	215	-
Behaviorn=335 Participants	193	-

Safety / tolerability / PK

2 endpoints

Other/protocol endpoint

Number of Participants With Treatment Tolerability

Time frame:Week 24

event count, event

Other_pre_specified/registry result

Number of Participants With Treatment Tolerability

Time frame:Week 24

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilVery Goodn=331 Participants	186	-
Goodn=331 Participants	130	-
Moderaten=331 Participants	14	-
Poorn=331 Participants	1	-

Other clinical outcomes

8 endpoints

Secondary/protocol endpoint

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8

Time frame:Week 8

event count, event

Secondary/protocol endpoint

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16

Time frame:Week 16

event count, event

Secondary/protocol endpoint

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24

Time frame:Week 24

event count, event

Secondary/protocol endpoint

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF

Time frame:Week 24

event count, event

Secondary/registry result

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8

Time frame:Week 8

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilVery much improvedn=351 Participants	5	-
Much improvedn=351 Participants	68	-
Minimally improvedn=351 Participants	194	-
No changen=351 Participants	74	-
Minimally worsen=351 Participants	8	-
Much worsen=351 Participants	2	-

Secondary/registry result

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16

Time frame:Week 16

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilVery much improvedn=341 Participants	21	-
Much improvedn=341 Participants	119	-
Minimally improvedn=341 Participants	116	-
No changen=341 Participants	66	-
Minimally worsen=341 Participants	17	-
Much worsen=341 Participants	2	-

Secondary/registry result

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24

Time frame:Week 24

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilVery much improvedn=330 Participants	33	-
Much improvedn=330 Participants	129	-
Minimally improvedn=330 Participants	87	-
No changen=330 Participants	62	-
Minimally worsen=330 Participants	16	-
Much worsen=330 Participants	2	-
Very much worsen=330 Participants	1	-

Secondary/registry result

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF

Time frame:Week 24

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilVery much improvedn=352 Participants	34	-
Much improvedn=352 Participants	133	-
Minimally improvedn=352 Participants	95	-
No changen=352 Participants	70	-
Minimally worsen=352 Participants	17	-
Much worsen=352 Participants	2	-
Very much worsen=352 Participants	1	-

Other (unclassified)

2 endpoints

Other/protocol endpoint/low confidence

Number of Participants Receiving Other Medications

Time frame:Baseline and Week 24

event count, event

Other_pre_specified/registry result/low confidence

Number of Participants Receiving Other Medications

Time frame:Baseline and Week 24

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilBaselinen=370 Participants	205	-
Week 24n=370 Participants	270	-

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.