ADEPT-2

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated with Alzheimer’s Disease (ADEPT-2)

• IRAS ID

  1009617

• Contact name

  Ariana Mullin

• Contact email

  info@karunatx.com

• Sponsor organisation

  Karuna Therapeutics, Inc.

• Clinicaltrials.gov Identifier

  NCT06126224

• Research summary

  This is randomised, placebo-controlled study to test the safety and effectiveness of the drug ‘KarXT’ compared to placebo, in patients with psychosis associated with Alzheimer’s Disease (AD). Some people with AD have psychosis, which means they lose contact with reality. They may see or hear things that other people cannot see or hear (hallucinations) and believe things that are not actually true (delusions). There are no approved medicines for the treatment of psychosis associated with AD. The current treatment used for psychosis in AD includes medicines approved for other illnesses which are only modestly effective and with serious safety concerns. There is a need for safe and effective medicines for the treatment of psychosis in people with AD.
  KarXT is a new combination drug made up of trospium chloride and xanomeline tartrate that has not yet been approved as a treatment for psychosis associated with AD. The main purpose of this study is to see how well KarXT works in the treatment of psychosis associated with AD.
  KarXT will be compared to placebo which is a substance that looks the same as KarXT but does not contain any active medicine.
  Approximately 400 participants male and female, aged 55-90 are expected to take part in the study globally, approximately 10-30 patients will be enrolled from 4-8 hospitals in the UK. Participants will be in the study for up to 20 weeks and will attend multiple planned visits to the study site. This study is made up of the following periods:

  • 4-week screening period
  • 14-week randomised treatment Period
  • Safety Follow-up visit 2 weeks following the end of treatment

  Study procedures include but are not limited to: physical examinations, vital signs, questionnaires, electrocardiogram (ECG), blood and urine sample collection.
  This study is sponsored by Karuna Therapeutics, Inc.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  24/SC/0139

• Date of REC Opinion

  23 Jul 2024

• REC opinion

  Further Information Favourable Opinion