Acadia ACP-103-033
Research type
Research Study
Full title
A 52-Week Open-Label Extension Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects with Alzheimer's Disease
IRAS ID
221195
Contact name
Roy Jones
Contact email
Sponsor organisation
ACADIA Pharmaceuticals Inc
Eudract number
2016-001128-78
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
Patients with Alzheimer’s disease (AD) who have been experiencing symptoms of agitation (having trouble relaxing or slowing down) and aggression (difficulty controlling anger) are being asked to participate in this research study. To be eligible for this study patients must first complete the 12‐week, placebo-controlled study with pimavanserin.
The purpose of this research study is to:
To evaluate the safety and tolerability of pimavanserin after 52 weeks of treatment in patients with probable AD who have symptoms of agitation and aggression.
To evaluate the persistence of effects of pimavanserin on symptoms of agitation and
aggression.In this study, participants will be assigned to 20 mg once daily of pimavanserin in tablet form. After two weeks, the daily dose can be adjusted to either 34 mg or 20 mg based on assessment of clinical response. This is an open label study, meaning that the patient and the study doctor will know the dose of pimavanserin the patient is taking.
This research study will be conducted at approximately 70 sites around the world and will include about 432 participants who have symptoms of agitation or aggression associated with AD. A participant is expected to be in the study for approximately 56 weeks. The participation will involve 11 study visits.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0081
Date of REC Opinion
18 Apr 2017
REC opinion
Further Information Favourable Opinion