Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis (NCT03325556) | Clinical Trial Compass
CompletedPhase 3
Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis
United States392 participantsStarted 2017-09-27
Plain-language 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.
Who can participate
Age range50 Years – 90 Years
SexALL
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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
✕
What they're measuring
1
Time From Randomization to Relapse in the Double-blind (DB) Period
Timeframe: From randomization in the DB period through 26 weeks
. 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