ADEPT-4

A study to evaluate KarXT as a treatment for psychosis associated with Alzheimer's disease

Conditions

Sponsor

Karuna Therapeutics

Clinical Trial

Phase III

Status

Currently recruiting

Drug

KarXT

Countries

Belgium, Croatia, France, Germany, Greece, Hungary, Israel, Italy, Poland, Portugal, Romania, Serbia, Slovakia, Spain

Information about the drug that will be tested in the study

Administration

Oral capsules

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

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the following options:

Capsules of KarXT (specified dose on specified days)
Capsules of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).

Neither the participant nor their doctor will know if the person is receiving the investigational drug or the 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 of KarXT in people who have mild to severe Alzheimer's disease with moderate to severe psychosis related to Alzheimer’s disease.

How long will the treatment last?

14 weeks

What your involvement will entail?

During the study, participants will be asked to complete tests that will assess their memory, hallucination, delusion, agitation and psychosis (MMSE, NPI-C, CGI-S, CMAI, ADAS-Cog).
To complete some 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.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

Be between 55 and 90 years old
Have a diagnosis of possible or probable Alzheimer's disease, according to the National Institute on Aging - Alzheimer's Association Guidelines for All-cause Dementia and Alzheimer's Disease
Have results of brain scans taken during or subsequent to the onset of dementia
Have a study partner who has a sufficient contact with the participant and willing to participate in study procedures throughout the study duration
History of psychotic symptoms (according to the International Psychogeriatric Association [IPA] criteria) during the past two months.

Who cannot participate in the study?

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

Psychotic symptoms that are primarily attributable to a condition other than Alzheimer's disease causing dementia (e.g., schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features)
History of major depressive episode with psychotic features during the last 12 months
History of bipolar disorder, schizophrenia or schizoaffective disorder.

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