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Pimavanserin for Psychological Symptoms of Dementia

Start: May 21, 2018
End: May 6, 2022
Enrollment: 750

What Is This Study About?

Anxiety, mood swings, risk-taking, and apathy are some of the psychological symptoms experienced by people with dementia. This Phase 3 study will test whether pimavanserin, an antipsychotic drug approved to treat hallucinations and delusions in people with psychosis from Parkinson's disease, is effective in reducing psychological symptoms in people with dementia. Participants will take two tablets of either pimavanserin or a placebo every day for eight weeks. Researchers will measure any changes in psychological symptoms and monitor participants for any side effects.

Do I Qualify To Participate in This Study?

Minimum Age: 60 Years

Maximum Age: N/A

Must have:

  • Requires some or complete assistance with one or more of the following:
    • Daily activities related to living independently (e.g., transportation, meal preparation, shopping, housework, managing medications, managing personal finances)
    • Basic activities of daily living (e.g., personal hygiene, dressing, eating, incontinence)
  • Meets clinical criteria for at least one of the following disorders:
    • Parkinson's disease
    • Dementia with Lewy bodies
    • Alzheimer's disease
    • Vascular dementia
    • Frontotemporal degeneration spectrum disorders, including possible or probable:
      • Behavioral variant frontotemporal dementia
      • Progressive supranuclear palsy
      • Corticobasal degeneration
  • Able to attend study visits with a study partner or caregiver
  • Female participants must meet the following criteria:
    • Not pregnant or breastfeeding
    • Surgically sterile or at least one-year postmenopausal, or must agree to use a clinically acceptable method of contraception or be abstinent
  • Any antipsychotic medication must be discontinued for two weeks or long enough for the medication to clear the body (whichever is longer)
  • If not able to provide informed consent, then a legally acceptable representative must provide written informed consent

Must NOT have:

  • In hospice, is receiving end-of-life care, or is bedridden
  • Psychotic symptoms associated with delirium or substance abuse
  • Evidence of any unstable medical condition, including cancer, that in the judgment of the study leader could affect safe participation or study results
  • Has a personal or family history of long QT syndrome (a heart condition) or family history of sudden cardiac death
  • Evidence that a central nervous system abnormality is most likely causing the dementia, such as:
    • Brain tumor
    • Abnormal blood vessel structures
    • Evidence of more than four hemosiderin deposits (protein clusters storing excess iron in the body)
  • Positive urine test results for amphetamine/methamphetamine, barbiturates, cocaine, or phencyclidine. Participants who test positive for amphetamines and have a valid prescription may be retested if they agree to stop taking the medication during study participation. The presence of benzodiazepines, marijuana, or opiates does not necessarily exclude the participant from the study.
  • Previous participation in any prior study with pimavanserin or currently taking any pimavanserin drugs

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: ACADIA Pharmaceuticals Inc.

Source: ClinicalTrials.gov ID: NCT03575052