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CompletedPhase 4

A Comparison of Two Standard Therapies in the Management of Dementia With Agitation

Randomized Comparison of Monotherapy (Risperidone, Quetiapine, or Olanzapine) Versus Combination Therapy (Risperidone, Quetiapine, or Olanzapine + Divalproex)in the Management of Dementia With Agitation: A Pilot Comparison of Two Standard Therapies

Lead sponsor

Emory University

Assets

Divalproex / Olanzapine / Quetiapine / Risperidone

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥65

Primary endpoints

•Pittsburgh Agitation Scale (PAS)•DiMarco Rating Scale for Extrapyramidal Symptoms•UKU side effect rating scale:autonomic subscale

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 ID0673-2003

NCT IDNCT00208819

Timeline

Milestones

Study start2003-09 (month precision)

Study first posted2005-09-21estimated

Study completion2007-07actual (month precision)

Last update posted2013-11-13estimated

Assets

Drug assets

Divalproex Olanzapine Quetiapine Risperidone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•inpatients admitted to Wesley Woods Inpatient service for Dementia with psychosis and agitation; taking risperidone (up to 1.5 mg/day), quetiapine (up to 175 mg/day), or olanzapine (up to 7.5 mg/day)

Exclusion criteria

•prior sensitivity to risperidone, quetiapine, olanzapine or divalproex

Endpoints (8)

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)

Behavior / neuropsychiatric

Global cognition

1 endpoint

Primary/protocol endpoint

Mini-Mental State Exam (MMSE)

Mini-Mental State Examination (MMSE)

descriptive

Behavior / neuropsychiatric

3 endpoints

Primary/protocol endpoint

Pittsburgh Agitation Scale (PAS)

descriptive

Primary/protocol endpoint

Visual Analog Scale for Nighttime Sleep and Daytime drowsiness (VAS)

descriptive

Primary/protocol endpoint

Cohen-Mansfield Agitation Inventory

descriptive

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

DiMarco Rating Scale for Extrapyramidal Symptoms

descriptive

Primary/protocol endpoint/low confidence

UKU side effect rating scale:autonomic subscale

descriptive

Primary/protocol endpoint/low confidence

Behavioral Activity Rating Scale (BARS)

descriptive

Primary/protocol endpoint/low confidence

Confusion Assessment Method (CAM)

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.