ACADIA ACP-103-032
Research type
Research Study
Full 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
IRAS ID
208282
Contact name
Roy Jones
Contact email
Sponsor organisation
ACADIA Pharmaceuticals Inc
Eudract number
2016-001127-32
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
Patientswith Alzheimer's disease(AD)who havebeen experiencing symptoms of agitation (having trouble relaxing or slowing down) and aggression (difficulty controlling anger)are being asked to participate in this research study. The morbidity associated with these symptoms is recognized as a significant unmet need.
Pimavanserin's potential utility for the treatment of agitation and aggression in Alzheimer's is supported by the risk-benefit profile observed to date in patients with Parkinson's disease psychosis,a population similar in many ways to Alzheimer's disease patients with agitation and aggression.
The purpose of this researchstudy is to:
• Test the effect of the study drug (pimavanserin)compared to placebo(inactive pill) on symptoms of agitation and aggressionin patients with AD.
• Test how safe pimavanserinis and if it is well-tolerated.Patients who take part in this study will first receive two weeks of psychosocial therapy. This therapy involves a family member, a friend, or a caregiver spending time with the patient for at least ten to fifteen minutes at least 3 times a week to talk with, or do something, the patient enjoys doing.
Sometimes a simple therapy like this may help improve the patient's symptoms.
In this study, participants will be randomly assigned to receive one of three study drug treatments in tablet form: 20 mg pimavanserin, 40 mg pimavanserin,or placebo(inactive). This is a double-blind study, meaning that the patient and the study doctor will not know which of the three study drug treatments the patient will be taking.This research study will be conducted at approximately 70 sites around the world, will include about 306 participants, and participants are expected to be in the study for approximately 18 weeks. The participation will involve 6 study visits and a telephone call about 30 days after the final visit.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0389
Date of REC Opinion
18 Oct 2016
REC opinion
Further Information Favourable Opinion