ADEPT-1
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated with Alzheimer’s Disease Dementia
IRAS ID
1006963
Contact name
Ella Kleynerman
Contact email
Sponsor organisation
Karuna Therapeutics
Eudract number
2022-001515-10
Research summary
This is a randomised, double-blind, placebo-controlled relapse prevention study in patients with moderate to severe psychosis associated with mild to severe Alzheimer’s Disease (AD) dementia. Psychosis is when you lose some contact with reality, this might involve hallucinations and delusions. Psychosis occurs commonly in patients with AD dementia. Currently, there are no approved drug treatments. The current treatment used for psychosis in AD dementia includes medicines approved for other illnesses which are only modestly effective and with serious safety concerns.
KarXT is a new combination drug made up of trospium chloride and xanomeline tartrate that has not yet been approved as a treatment. It could provide an important and meaningful alternative to current therapies. The purpose of this study is to see if KarXT is safe, tolerable, and effective in the treatment of psychosis in AD dementia patients compared to a placebo.
Approximately 380 participants male and female, aged 55-90 are expected to take part in the study globally, approximately 17 patients will be enrolled from 5 hospitals in the UK. These participants will have mild to severe AD dementia with moderate to severe psychosis. Participants will be in the study for up to 44 weeks and will attend multiple planned visits to the study site. This study is made up of the following periods:
• Up to 30-day Screening Period
• 38-week Treatment Period
• Safety Follow-up (SFU) visit 2 weeks following the end of treatment (EOT)Study procedures include but are not limited to: physical examinations, vital signs, questionnaires, electrocardiogram (ECG), either an MRI or a CT scan of the brain to confirm eligibility for the study, if there is not a recent scan within 5 years, blood and urine sample collection. This study is sponsored by Karuna Therapeutics, Inc.
REC name
Wales REC 5
REC reference
23/WA/0049
Date of REC Opinion
5 Sep 2023
REC opinion
Further Information Favourable Opinion