ADEPT-1 Study

What is Psychosis Associated with Alzheimer’s Disease (AD) Dementia?

Psychosis associated with Alzheimer’s disease (AD) dementia often presents as delusions, paranoia, or hallucinations (seeing o hearing things that are not there), and can become more prevalent as the disease worsens.

These include delusions of: persecution, infidelity, abandonment, misidentification delusions or the belief that loved ones close to them who have passed are still living.

While a diagnosis of dementia and AD often focuses on cognitive deficits, the behavioral symptoms of psychosis and agitation often are the most troublesome for caregivers and lead to poor quality of life for patients.

About the study:

ADEPT-1 is a 38-week clinical study.
It will evaluate the safety and efficacy of KarXT, an oral medication, for the treatment of psychosis associated with Alzheimer’s disease dementia.
The purpose of this study is to evaluate if the study drug, may help to prevent relapse of psychosis in people with AD dementia compared to placebo (a substance that looks like KarXT but does not contain an active drug)

What to expect from ADEPT-1 study?

Do you or someone you know live with psychosis associated with Alzheimer’s Disease Dementia?

To qualify for this clinical research study, participants must:

Be between the ages of 55 and 90 years old
Have been diagnosed with mild to severe Alzheimer’s disease dementia with moderate to severe psychosis (hallucinations and/or delusions)

Have a caregiver that will be able to attend all visits, report on the patient’s status, oversee medication and treatment, and participate in some written study assessments

Screening Period

To take part in this study, the participant will need to be evaluated to determine eligibility. It may take up to 30 days to evaluate a potential participant’s eligibility for the study.

Study Treatment Period

All participants will receive the study drug, KarXT and may receive placebo (a drug with no active ingredients), daily at some point in the study. Dosing is flexible and can change based on how well the participant tolerates the study drug and how well the study drug is working.

Follow-up Period

Once the participant stops taking the study drug, a follow-up visit will be performed to see how the participant is doing. The follow-up visit will occur two weeks after the last study visit.

Extension Period

Participants who complete the 38-week study may be eligible for a one-year, long-term Open-Label Extension (OLE) safety study.

Benefits joining in ADEPT-1 study

Play a role in the advancement of Alzheimer’s disease with psychosis treatment
Receive care from a local doctor at no cost to you or your study partner/caregiver
Contribute to the data collected during this study that may help doctors learn more about KarXT and your disease
Your time and effort can be financially rewarded.
You can withdraw at any time, for any reason.