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A Single Center, Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Psychosis in Alzheimer's Disease

Trial Profile

A Single Center, Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Psychosis in Alzheimer's Disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 22 Jun 2022

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At a glance

  • Drugs Pimavanserin (Primary)
  • Indications Psychotic disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Acadia Pharmaceuticals
  • Most Recent Events

    • 17 Jun 2022 According to an ACADIA Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 9 to 3 for pimavanserin that the evidence presented does not support a conclusion that pimavanserin is effective for the treatment of hallucinations and delusions in the ADP population. The FDA is not bound by the PDAC's recommendations, but takes its advice into consideration when making decisions on drug applications.
    • 02 May 2022 According to an ACADIA Pharmaceuticals media release, a virtual meeting of the U.S. Food and Drug Administration Psychopharmacologic Drugs Advisory Committee to review the resubmitted supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer disease psychosis (ADP) has been scheduled for June 17, 2022.
    • 09 Mar 2022 According to an Acadia Pharmaceuticals media release, the company has received a target action date of August 4, 2022 from the U.S. Food and Drug Administration (FDA) for its resubmitted supplemental New Drug Application (sNDA) and the FDA's Division of Psychiatry has advised the company that it is planning to hold an Advisory Committee meeting in connection with its review.
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