Clinical Trial: Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease

Brief Summary: To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment

Detailed Summary:
Sponsor: ACADIA Pharmaceuticals Inc.

Current Primary Outcome: Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: Approximately 12 weeks ]

Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: ACADIA Pharmaceuticals Inc.

Dates:
Date Received: December 12, 2016
Date Started: November 2016
Date Completion: July 2019
Last Updated: April 18, 2017
Last Verified: April 2017