Extension study for KARXT in patients with AD
Research type
Research Study
Full title
OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF KARXT IN SUBJECTS WITH PSYCHOSIS ASSOCIATED WITH ALZHEIMER’S DISEASE
IRAS ID
1008013
Contact name
Ariana Mullin
Contact email
Sponsor organisation
Karuna Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
This is an open label extension study to test the long-term safety and tolerability of the drug ‘KarXT’ in patients with psychosis associated with Alzheimer’s Disease (AD). Psychosis is when you lose some contact with reality. This might involve hallucinations and delusions. Psychosis occurs commonly in patients with AD. Currently, there are no approved drug treatments. The current treatment used for psychosis in AD 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 and tolerable in the treatment of psychosis in AD patients.
Approximately 220-300 people, aged 55-90 are expected to take part in the study globally, approximately 17 patients will be enrolled from 4 hospitals in the UK. These participants will have AD with psychosis and will have completed the original KarXT AD study before having the choice to join this extension study. Participants will be in the study for up to 54 weeks and will attend multiple planned visits to the study site. This study is made up of the following periods:
• Screening period
• 52-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), blood and urine sample collection.
This study is sponsored by Karuna Therapeutics, Inc.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0097
Date of REC Opinion
8 Jul 2024
REC opinion
Further Information Unfavourable Opinion