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CompletedPhase 2Results posted

A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease Psychosis

A Single Center, Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Psychosis in Alzheimer's Disease

Lead sponsor

ACADIA Pharmaceuticals Inc.

Asset

Pimavanserin

Listed sites

Recruiting sites

Enrollment

181

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Neuropsychiatric Inventory (NPI)

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 IDACP-103-019

NCT IDNCT02035553

Timeline

Milestones

Study start2013-11 (month precision)

Study first posted2014-01-14estimated

Primary completion2016-09-28actual

Study completion2016-10-27actual

Last update posted2017-10-25actual

Results first posted2017-10-25actual

Assets

Drug assets

Pimavanserin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patient must be 50 years of age or older with NINCDS-ADRDA defined possible or probable AD

•Patient must have psychotic symptoms that developed after the diagnosis of AD was established. These symptoms must include visual and/or auditory hallucinations, and/or delusions

•Patient must have been a nursing home resident for ≥ 4 weeks prior to randomization, not bedridden and expected to remain in the facility throughout the study

•Patient must have actively experienced and verbally communicated psychotic symptoms during the month prior to the Screening visit and weekly during the previous 2 weeks prior to Baseline

•If patient is on acetylcholinesterase inhibitor (AChEI) therapy and/or memantine, must be on stable doses for 3 months prior to the Baseline visit and during the study

•Patient is willing and able to provide informed consent. If the subject is unable to provide written consent due to the severity of dementia, consent must be given by a legally authorized representative

Exclusion criteria

•Patient has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Alzheimer's disease including, but not limited to, schizophrenia or bipolar disorder

•Patient is unable to communicate verbally

•Patient has current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study

•Patient has had a myocardial infarction in the last six months

•Patient has moderate to severe congestive heart failure

•Patient has any surgery planned during the screening, treatment, or follow-up periods that could interfere with participation in the study per the protocol assessments

Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).

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.

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Antipsychotic Efficacy

Time frame:Day 43

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/registry result

Antipsychotic Efficacy

Time frame:Day 43

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on the NPI-NH scale	Reported bounds
Placebon=91 Participants	-1.93	--3.18 - -0.67
Pimavanserin 40 mgn=87 Participants	-3.76	--5.05 - -2.47

Diff in MMRM LSM-1.8495% CI-3.64 - -0.04p0.0451Mixed Models Analysis

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 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.