ADEPT-3

Open-label extension study to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's disease

Conditions

Sponsor

Karuna Therapeutics

Clinical Trial

Status

Drug

KarXT (combines xanomeline with trospium)

Countries

Bulgaria, Czechia, Poland, Slovakia, Spain

This study is an open-label extension study.

Oral capsules

All participants will receive capsules of KarXT (different doses)

The purpose of the study is to evaluate the long-term safety and tolerability of KarXT in people with psychosis associated with Alzheimer's disease.

During the study, participants will be asked to complete laboratory and biological tests to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)

Further information on the procedures, tests and number of visits can be obtained from the study team.

To take part in the study, participants must:

Be between 55 and 90 years old
Have completed previous studies investigating KarXT (studies CN012-0026 or CN012-0027)
If the participant needs to relocate to a nursing home facility, the medical team must approve his/her participation in the study
Have a study partner who has a sufficient contact with the participant (10 hours/week), is willing to participate in study procedures throughout the study duration.

People cannot take part in the study if they have or have experienced:

A disease or a condition that may interfere with the safety or study assessments (e.g., pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular, or oncologic disease
Participation in another clinical study or planning on participating in another clinical study during this study.

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