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UnknownPhase 3

Donepezil Treatment of Psychotic Symptoms in Dementia Patients

Donepezil as Add-On Treatment of Psychotic Symptoms in Patients With Dementia of the Alzheimer's Type

Asset

Donepezil

Listed sites

1

Recruiting sites

-

Enrollment

80

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Possitive and Negative Syndrome Scale•Clinical Global Impression

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 IDBMHC-3495CTIL
NCT IDNCT00190021

Timeline

Milestones

Study first posted2005-09-19estimated
Last update posted2010-09-08estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•age: 65-90
•DSM-IV diagnosis of Alzheimer's type dementia
•inclusion of psychotic symptoms such as: hallucinations and delusions, aggression/agitation, irritability and disinhibition calling for adminstration of antipsychotic drugs
•duration of psychotic symptoms of at least 2 weeks before start of treatment
•lack of improvement of psychotic symptoms during perphenazine treatment for at least 3 weeks

Exclusion criteria

•vascular demential
•concurrent Axis I DSM-IV diagnosis (delirium, schizophrenia, delusional disorder and affective disorders)
•significant medical illness (cardiovascular, liver, renal, edocrinal, B12 or folic acid deficience and neurological illnesses)
•drug or alcohol addiction

Endpoints (2)

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
1
Other (unclassified)
1

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

Clinical Global Impression

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Possitive and Negative Syndrome Scale

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.