Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

Phase 3

Completed

• Conditions: Dementia-related Psychosis
• Interventions: Drug: Placebo; Drug: Pimavanserin 34 mg; Drug: Pimavanserin 20 mg

• Registration Number: NCT03325556
• Lead Sponsor: ACADIA Pharmaceuticals Inc.

Brief Summary

The purpose of this study is to evaluate the efficacy of pimavanserin compared to placebo in preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who responded to 12 weeks of open label pimavanserin treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-27
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-30
• Primary Completion: 2019-07-31
• Study Completion: 2019-10-30
• Disposition First Submitted: 2020-04-15
• Results First Submitted: 2021-04-30
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-27
• Disposition First Submitted QC: 2021-05-27
• Last Update Submitted: 2021-05-27
• Results First Posted: 2021-06-21
• Disposition First Posted: 2021-06-21
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Drug - Pimavanserin	Pimavanserin 34 mg	-
Drug - Pimavanserin	Pimavanserin 20 mg	-

Primary Outcome Measures

Name	Time	Method
Time From Randomization to Relapse in the Double-blind (DB) Period	From randomization in the DB period through 26 weeks	The time from randomization to relapse in the DB period was compared between treatment groups using a Cox regression model. The treatment effect was measured by the hazard ratio (HR).; Relapse was defined as (1) ≥30% increase in SAPS-H+D total score from DB baseline (BL) and CGI-I score ≥6 relative to DB BL, (2) treatment with antipsychotic for dementia-related delusions/hallucinations, (3) treatment/study discontinuation due to lack of efficacy, and/or (4) hospitalization for worsening dementia-related psychosis.; SAPS-H+D is a 20-item scale; the total score is the sum of the 20 item scores (range 0-100); higher scores denote more severe symptoms. CGI-I is a clinician-rated 7-point scale to rate improvement in hallucinations/delusions relative to BL (range 1-7); higher scores denote less improvement or worsening.; A pre-specified IA was conducted after accrual of 40 adjudicated relapse events. The prespecified stopping criterion was met; the study was stopped for efficacy.

Secondary Outcome Measures

Name	Time	Method
Time From Randomization to Discontinuation From the DB Period for Any Reason	From randomization in the DB period through 26 weeks	The endpoint of time from randomization to discontinuation from the DB period for any reason (other than termination of the study by the sponsor) was compared between treatment groups using a Cox regression model. The treatment effect was measured by the HR.

Trial Locations

Locations (83)

ATP Clinical Research Inc.; 🇺🇸 Costa Mesa, California, United States

Neurology Center of North Orange County; 🇺🇸 Fullerton, California, United States

Visionary Investigators Network (Aventura Neurologic Associates); 🇺🇸 Aventura, Florida, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton; 🇺🇸 Boca Raton, Florida, United States

Premier Clinical Research Institute, Inc.; 🇺🇸 Miami, Florida, United States

Visionary Investigators Network (First Choice Neurology Group); 🇺🇸 Miami, Florida, United States

Novel Clinical Research Center, LLC; 🇺🇸 Miami, Florida, United States

Collier Neurologic Specialists LLC; 🇺🇸 Naples, Florida, United States

Bioclinica Research; 🇺🇸 Orlando, Florida, United States

Neurology Associates of Ormond Beach; 🇺🇸 Ormond Beach, Florida, United States

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