CompletedPhase NA

CATIE-Alzheimer's Disease Trial

Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimer's Disease (CATIE Alzheimer's Disease Trial)

Lead sponsor

National Institute of Mental Health (NIMH)

Assets

Citalopram / Olanzapine / Quetiapine / Risperidone

Listed sites

Recruiting sites

Enrollment

450

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

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

SecondaryDSIR AT

Org study IDN01 MH090001-05

SecondaryN01 MH90001-AD

NihN01MH090001

NihN01MH90001

NCT IDNCT00015548

Timeline

Milestones

Study start2001-03 (month precision)

Study first posted2001-04-23estimated

Study completion2004-10 (month precision)

Last update posted2015-06-17estimated

Assets

Drug assets

Citalopram Olanzapine Quetiapine Risperidone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Eligibility criteria

•Diagnosis of Dementia of the Alzheimer's Type

•Ambulatory, Outpatients who have an informant living/visiting at least 8 hours/week over 3-4 days.

•Presence of delusions, hallucinations, agitation impacting functioning and requiring medication treatment

•Agitation or psychotic symptoms began after signs or symptoms of dementia

Exclusion (prospective participants must not:)

•Be benefiting from psychotropic medication, antidepressants or anticonvulsants

•Be diagnosed with schizophrenia, schizoaffective disorder, delusional disorder or mood disorder with psychotic features.

•Have severe or unstable medical illness requiring active treatment

•Have hypersensitivity or intolerance of any of the study medications

Endpoints (0)

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.

No endpoints recorded for this trial.

Publications (11)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.