Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis
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| ClinicalTrials.gov Identifier: NCT03325556 |
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Recruitment Status :
Completed
First Posted : October 30, 2017
Results First Posted : June 21, 2021
Last Update Posted : June 21, 2021
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| 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) |
| Actual Enrollment : | 392 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 |
| Actual Primary Completion Date : | July 31, 2019 |
| Actual Study Completion Date : | October 30, 2019 |
| 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 |
- 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.
- 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.
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| Ages Eligible for Study: | 50 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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 ClinicalTrials.gov identifier (NCT number): NCT03325556
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Documents provided by ACADIA Pharmaceuticals Inc.:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ACADIA Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT03325556 |
| Other Study ID Numbers: |
ACP-103-045 2017-002227-13 ( EudraCT Number ) |
| First Posted: | October 30, 2017 Key Record Dates |
| Results First Posted: | June 21, 2021 |
| Last Update Posted: | June 21, 2021 |
| Last Verified: | May 2021 |
| 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 |
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Dementia Dementia-related psychosis Dementia associated with Parkinson's disease Dementia with Lewy bodies Alzheimer's disease Behavioral variant frontotemporal dementia |
Progressive supranuclear palsy Corticobasal degeneration Vascular dementia Hallucinations Delusions Psychosis |
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Dementia Psychotic Disorders Mental Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Schizophrenia Spectrum and Other Psychotic Disorders Pimavanserin Antiparkinson Agents Anti-Dyskinesia Agents |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |