Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03325556
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : March 7, 2018
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Brief Summary:
The purpose of this study is to evaluate the efficacy of pimavanserin by comparing pimavanserin with placebo in preventing a relapse of psychotic symptoms in subjects with dementia-related psychosis and who were stabilized after 12 weeks of open label pimavanserin treatment.

Condition or disease Intervention/treatment Phase
Dementia-related Psychosis Drug: Placebo Drug: Pimavanserin 34 mg Drug: Pimavanserin 20 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis
Actual Study Start Date : September 27, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo, tablets, once daily by mouth
Experimental: Drug - Pimavanserin Drug: Pimavanserin 34 mg
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth
Drug: Pimavanserin 20 mg
Pimavanserin 20 mg total daily dose, tablets, once daily by mouth

Primary Outcome Measures :
  1. Time from randomization to relapse in the double-blind period [ Time Frame: Up to 26 weeks ]

Secondary Outcome Measures :
  1. Time from randomization to discontinuation from the double-blind period for any reason [ Time Frame: Up to 26 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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 greater than New York Heart Association (NYHA) Class 2 congestive heart failure or Class 2 angina pectoris, sustained ventricular tachycardia, ventricular fibrillation, or torsade de pointes, or syncope due to an arrhythmia
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03325556

Contact: Scott Stubbe 858-261-2968
Contact: Siobhan Shawbell 858-366-6207

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Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

Responsible Party: ACADIA Pharmaceuticals Inc. Identifier: NCT03325556     History of Changes
Other Study ID Numbers: ACP-103-045
2017-002227-13 ( EudraCT Number )
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ACADIA Pharmaceuticals Inc.:
Dementia-related psychosis
Dementia associated with Parkinson's disease
Dementia with Lewy bodies
Behavioral variant frontotemporal dementia
Vascular dementia
Alzheimer's disease
Progressive supranuclear palsy
Corticobasal degeneration

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Antiparkinson Agents
Anti-Dyskinesia Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action