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NCT Number: NCT03325556

Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

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.

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Key information

Conditions

Dementia-related Psychosis Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Corticobasal Degeneration Cranial Nerve Diseases Delusions Dementia Dementia, Vascular Eye Diseases Hallucinations Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Perceptual Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Supranuclear Palsy, Progressive Synucleinopathies Tauopathies Vascular Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mental Health Center - Ruse EOOD, Rousse, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meets criteria for All-cause Dementia according to NIA-AA guidelines
  • 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
  • Has an MMSE score ≥6 and ≤24
  • Has had psychotic symptoms for at least 2 months
  • Must be on a stable does of cholinesterase inhibitor or memantine, if applicable
  • 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

  • Has psychotic symptoms that are primarily attributable to a condition other than dementia
  • Has had a recent major depressive episode
  • Has experienced suicidal ideation or behavior within 3 months prior to study enrollment
  • Has evidence of a non-neurologic medical comorbidity or medication use that could substantially impair cognition
  • Has a history of ischemic stroke within the last 12 months or any evidence of hemorrhagic stroke
  • Has a known history of cerebral amyloid angiopathy (CAA), epilepsy, CNS neoplasm, or unexplained syncope
  • 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
  • Had a myocardial infarction within the last 6 months
  • Has a known personal or family history or symptoms of long QT syndrome
  • Has a significant unstable medical condition that could interfere with subject's ability to complete the study or comply with study procedures
  • 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.

Treatment and study plan

Placebo

Drug

Placebo, tablets, once daily by mouth

Pimavanserin 34 mg

Drug

Pimavanserin 34 mg total daily dose, tablets, once daily by mouth

Pimavanserin 20 mg

Drug

Pimavanserin 20 mg total daily dose, tablets, once daily by mouth

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

ACADIA Pharmaceuticals Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 30, 2017
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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