Last updated on August 2019

Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dementia-related Psychosis
  • Age: Between 50 - 90 Years
  • Gender: Male or Female

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 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:

  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 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
  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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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