← Trials/Trial dossier/NCT00245206

CompletedPhase 4

Side Effects of Newer Antipsychotics in Older Adults

Metabolic Effects of Newer Antipsychotics in Older Patients

Lead sponsor

Veterans Medical Research Foundation

Assets

Aripiprazole / Olanzapine / Risperidone

Listed sites

Recruiting sites

Enrollment

406

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥40

Primary endpoints

•Body Mass Index•Fasting Plasma Glucose (FPG)•LDL cholesterol, HDL cholesterol, and triglycerides

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

RegistryDATR A5-ETSEClinicaltrials.gov

NCT IDNCT00245206

Org study IDR01MH071536https://reporter.nih.gov/quickSearch/R01MH071536

NihR01MH071536

Timeline

Milestones

Study start2005-08 (month precision)

Study first posted2005-10-27estimated

Primary completion2010-10actual (month precision)

Study completion2010-10actual (month precision)

Last update posted2018-12-17actual

Assets

Drug assets

Aripiprazole Olanzapine Risperidone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age40 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication

Exclusion criteria

•N/A

Endpoints (3)

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.

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Change in Body Mass Index

Time frame:Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Fasting Plasma Glucose (FPG)

Time frame:Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in LDL cholesterol, HDL cholesterol, and triglycerides

Time frame:Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

change from baseline, improvement

Publications (2)

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.