Phase 3 study of pimavanserin vs placebo in dementia patients
Research type
Research Study
Full title
A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis
IRAS ID
233484
Contact name
Julian Hughes
Contact email
Sponsor organisation
ACADIA Pharmaceuticals Inc.
Eudract number
2017-002227-13
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Patients with dementia who have been experiencing symptoms of psychosis (hallucinations and/or delusions) are being asked to participate in this research study.
The purpose of this research study is to:
• Investigate the effect of the study drug (pimavanserin) compared to placebo (inactive pill) on preventing relapse of psychosis in patients who respond to treatment with pimavanserin
• Investigate pimavanserin safety and tolerability.
Before receiving study medication, patients who take part in this study will first receive Brief Psychosocial Therapy. This is a standardized therapy developed by Prof. Clive Ballard of the University of Exeter. This therapy involves a family member, a friend, or another caregiver spending time with the patient for at least ten to fifteen minutes at least several times a week to talk with, or do something, the patient enjoys doing. Only patients whose symptoms still merit treatment with medication will continue in the study.
All participants (100%) will receive pimavanserin in the first part (open-label) portion of the study. If they experience a clinical response while on pimavanserin, they may qualify to enter the second part of the study. Patients who do not have a clinical response to pimavanserin will leave the study and will receive standard of care therapy from their doctors.
In the second part of the study (the double-blind phase), the participant will be randomly assigned to receive either the same dose of pimavanserin they were previously taking or placebo (inactive pills). Participants will have a 50% chance of receiving pimavanserin in this study phase, and 50% chance of receiving placebo. The study team will be recording the time it takes for subjects to experience a relapse of their psychotic symptoms. This is a double-blind study, meaning that the patient and the study doctor will not know whether the patient is taking pimavanserin or placebo. Subjects who relapse or who seem about to relapse will leave the study and will receive standard of care therapy from their doctors.
This research study will be conducted at approximately 95 sites around the world and will include about 356 participants who have psychosis associated with dementia. A participant is expected to be in the study for approximately 46 weeks. The participation will involve a maximum of 17 study visits and a telephone call about 30 days after the final visit.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
17/SC/0595
Date of REC Opinion
4 Feb 2018
REC opinion
Further Information Favourable Opinion