CompletedPhase 3Results posted

Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis

Lead sponsor

ACADIA Pharmaceuticals Inc.

Asset

Pimavanserin

Listed sites

Recruiting sites

Enrollment

392

actual

Study population

Alzheimer’s disease, Frontotemporal dementia, Lewy body dementia, Vascular cognitive impairment / dementia

Key I/E criteria

•Multiple dementia etiologies•MMSE 6-24

Primary endpoint

•Time From Randomization to Relapse in the Double-blind (DB) Period

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

Eudract number2017-002227-13

Org study IDACP-103-045

NCT IDNCT03325556

Timeline

Milestones

Study start2017-09-27actual

Study first posted2017-10-30actual

Primary completion2019-07-31actual

Study completion2019-10-30actual

Last update posted2021-06-21actual

Results first posted2021-06-21actual

Assets

Drug assets

Pimavanserin

Study populations

Who this study enrolls

Alzheimer’s diseaseFrontotemporal dementiaLewy body dementiaVascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Meets criteria for All-cause Dementia according to NIA-AA guidelines

2. Meets clinical criteria for one of the following disorders: Dementia associated with Parkinson's disease, Dementia with Lewy bodies, Possible or probable Alzheimer's disease, Frontotemporal degeneration spectrum disorders, Vascular dementia

3. Has an MMSE score ≥6 and ≤24

4. Has had psychotic symptoms for at least 2 months

5. Must be on a stable does of cholinesterase inhibitor or memantine, if applicable

6. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential or must agree to use a clinically acceptable method of contraception for the duration of the study

Exclusion criteria

1. Has psychotic symptoms that are primarily attributable to a condition other than dementia

2. Has had a recent major depressive episode

3. Has experienced suicidal ideation or behavior within 3 months prior to study enrollment

4. Has evidence of a non-neurologic medical comorbidity or medication use that could substantially impair cognition

5. Has a history of ischemic stroke within the last 12 months or any evidence of hemorrhagic stroke

6. Has a known history of cerebral amyloid angiopathy (CAA), epilepsy, CNS neoplasm, or unexplained syncope

7. Has any of the following: greater than New York Heart Association (NYHA) Class 2 congestive heart failure, Grade 2 or greater angina pectoris, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, syncope due to an arrhythmia, an implantable cardiac defibrillator

8. Had a myocardial infarction within the last 6 months

9. Has a known personal or family history or symptoms of long QT syndrome

10. Has a significant unstable medical condition that could interfere with subject's ability to complete the study or comply with study procedures

11. Requires treatment with a medication or other substance that is prohibited by the protocol

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Endpoints (4)

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

Behavior / neuropsychiatric

Other (unclassified)

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Time From Randomization to Relapse in the Double-blind (DB) Period

Time frame:From randomization in the DB period through 26 weeks

change from baseline, improvement

Primary/registry result

Time From Randomization to Relapse in the Double-blind (DB) Period

Time frame:From randomization in the DB period through 26 weeks

change from baseline, improvement

Posted result

Group	Value (median), days	Reported bounds
Pimavanserin Double-Blind Periodn=95 Participants	NA	-NA - NA
Placebo Double-Blind Periodn=99 Participants	NA	-NA - NA

Hazard Ratio (HR)0.35395% CI0.172 - 0.727p0.0023Regression, Cox

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Time From Randomization to Discontinuation From the DB Period for Any Reason

Time frame:From randomization in the DB period through 26 weeks

descriptive

Secondary/registry result/low confidence

Time From Randomization to Discontinuation From the DB Period for Any Reason

Time frame:From randomization in the DB period through 26 weeks

descriptive

Posted result

Group	Value (median), days	Reported bounds
Pimavanserin Double-Blind Periodn=95 Participants	NA	-NA - NA
Placebo Double-Blind Periodn=99 Participants	NA	-NA - NA

Hazard Ratio (HR)0.45295% CI0.261 - 0.785p0.0024Regression, Cox

Publications (3)

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.