Study Information

Name of the study

A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis

Study sponsor

ACADIA Pharmaceuticals Inc. 

Disease

People with dementia-related psychosis

Phase

Phase 3

Information about the drug that will be tested in the study

Name of drug

Pimavanserin

Administration

Two tablets taken orally once a day

Is the drug already on the market for another medical condition?

The drug is approved in United States for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Will all participants receive the same drug?

All participants will receive the same drug (pimavanserin at a dose of 34 mg/day or 20 mg/day) for up to 12 weeks to assess whether they improve with treatment. After 12 weeks, all participants who show improvement will be selected by chance to receive at least one of the following options:

• Pimavanserin at the final dose taken in the first 12 weeks, or
• Placebo tablets (also called a dummy treatment which is a substance identical in appearance to the drug being tested with no active therapeutic effect).

After 12 weeks, neither the participant nor their doctor will know if the person is receiving pimavanserin or placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the safety and efficacy and safety of pimavanserin in treating hallucinations and/or delusions in subjects with dementia-related psychosis.

How long will the treatment last?

• Approximately 38 weeks
• The study consists of 2 periods:
  • Open-label period: each participant will receive a daily dose of 34 mg of pimavanserin for 12 weeks (may be adjusted between 20 mg and 34 mg if clinically justified)
  • Double-blind period: participants, who were stabilised after 12 weeks of open label treatment, will receive pimavanserin (20 or 34 mg) or placebo for 26 weeks.

What your involvement will entail?

During the study, participants will need to attend regular study appointments with the study doctor and research staff.

Further information on the number of visits can be obtained from the study team. 

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

• Be 50 to 90 years old
• Have one of the following disorders: dementia associated with Parkinson's disease, dementia with Lewy bodies, possible or probable Alzheimer's disease, frontotemporal degeneration spectrum disorders or vascular dementia
• Have psychotic symptoms (hallucinations and/or delusions) for at least 2 months
• If the person is taking an approved anti-dementia medication (i.e. donepezil, rivastigmine, galantamine or memantine) the dosing regimen must be stable
• If the subject is female, she must be of non-childbearing potential or must agree to use a clinically acceptable method of contraception for the duration of the study.

Who cannot participate in the study?

Exclusion criteria include:

• Psychotic symptoms that are primarily attributable to a condition other than dementia
• History of suicidal behaviour in past 3 months or recent major depressive episode
• History of certain neurological disorders (e.g. cerebral amyloid angiopathy, epilepsy, unexplained syncope, recent stroke)
• History of myocardial infarction (heart attack) within the past 6 months
• An unstable medical condition that may interfere with the safety, tolerability, and/or study assessments.
• History or family history of long QT syndrome (disorder of heart rhythm).

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Where and when will the study be conducted?

European countries involved in the trial

• Bulgaria
• Czech Republic
• France
• Germany
• Italy
• Poland
• Serbia
• Slovakia
• Spain
• Ukraine
• UK

Estimated start date of recruitment

September 2017

Information for your doctor

EudraCT Number

2017-002227-13

Clinicaltrials.gov identifier

NCT03325556  

Study contact information

Scott Stubbe: sstubbe@acadia-pharm.com

Siobhan Shawbell: sshawbell@acadia-pharm.com

Link to full text

https://clinicaltrials.gov/ct2/show/study/NCT03325556?term=Pimavanserin&rank=9&show_locs=Y

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on November 2018. 

This document has been reviewed by the pharmaceutical company running this trial.

This document has been reviewed by a member of the European Working Group of People with Dementia.