Status:
COMPLETED
Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis
Lead Sponsor:
ACADIA Pharmaceuticals Inc.
Conditions:
Dementia-related Psychosis
Eligibility:
All Genders
50-90 years
Phase:
PHASE3
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 we...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2019
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT03325556
Start Date
September 27 2017
End Date
October 30 2019
Last Update
June 21 2021
Active Locations (83)
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1
ATP Clinical Research Inc.
Costa Mesa, California, United States, 92626
2
Neurology Center of North Orange County
Fullerton, California, United States, 92835
3
Visionary Investigators Network (Aventura Neurologic Associates)
Aventura, Florida, United States, 33180
4
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486