Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Dementia-related Psychosis

In brief

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.

Key facts

Study ID

NCT03325556

Run by

ACADIA Pharmaceuticals Inc.

People needed

392

Starts

2017-09-27

Expected to finish

2019-10-30

Last updated by the study team

2021-06-21

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Neurology Center of North Orange County — Fullerton, California, United States
• Visionary Investigators Network (Aventura Neurologic Associates) — Aventura, Florida, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• Premier Clinical Research Institute, Inc. — Miami, Florida, United States
• Visionary Investigators Network (First Choice Neurology Group) — Miami, Florida, United States
• Novel Clinical Research Center, LLC — Miami, Florida, United States
• Collier Neurologic Specialists LLC — Naples, Florida, United States
• Bioclinica Research — Orlando, Florida, United States
• Neurology Associates of Ormond Beach — Ormond Beach, Florida, United States
• Quantum Laboratories — Pompano Beach, Florida, United States
• Neuroscience Research Institute — Winfield, Illinois, United States
• University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States
• Alzheimer Disease Center — Quincy, Massachusetts, United States
• Clinical Research Professionals — Chesterfield, Missouri, United States
• Millennium Psychiatric Associates, LLC; DBA Millennium Center for Clinical Research — St Louis, Missouri, United States
• Neurology Center of Las Vegas — Las Vegas, Nevada, United States
• Memory Enhancement Center of America, Inc. — Eatontown, New Jersey, United States
• BioBehavioral Health — Toms River, New Jersey, United States
• Neurological Associates of Albany, PC — Albany, New York, United States
• Manhattan Behavioral Medicine, PLLC — New York, New York, United States
• Richmond Behavioral Associates — Staten Island, New York, United States
• Neuro-Behavioral Clinical Research, Inc. — North Canton, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Abington Neurological Associates Ltd. — Willow Grove, Pennsylvania, United States
• ATP Clinical Research Inc. — Costa Mesa, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.