Alzheimer's Disease Psychosis
(Delusions or hallucinations)
This study is evaluating the safety and efficacy of KarXT for the treatment of psychosis associated with Alzheimer’s disease dementia. The purpose of this study is to evaluate if the study drug, KarXT, 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 any active drug). Participants must be between the ages of 55 and 90 years old and have mild to severe AD dementia with moderate to severe psychosis.
By participating in this study, you as the participant will:
- Play a role in the advancement of Alzheimer’s disease with psychosis treatment
- Contribute to the data collected during this study that may help doctors learn more about KarXT and your disease
- Receive care from a local doctor at no cost to you or your study partner/caregiver
Thank you for your consideration in enrollment. By participating in this clinical study, you help doctors learn more about potential treatments for psychosis in Alzheimer’s disease. You may even help others diagnosed with this disease, and potentially receive a possible new treatment option to help manage your symptoms. During the study, the participant will receive care and attention from a local doctor and study staff.
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.
Psychosis associated with Alzheimer’s disease (AD) dementia often presents as delusions, paranoia, or hallucinations, 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 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.
A clinical study is a type of research study designed to evaluate whether a study drug is safe and effective for use in humans. Participants are given specific medical treatments and researchers closely monitor the results to help determine if the drug should be approved for wider use. The U.S. Food and Drug Administration (FDA) has strict rules that govern how clinical studies are conducted and requires that a study drug be proven safe and effective before it can be widely used in the United States.
A study drug is a drug that has not been approved by the U.S. Food and Drug Administration (FDA) but can be administered to people in a clinical study for research purposes.
Individuals may be eligible for the study if they:
- Are age 55 - 90
- Have been diagnosed with Alzheimer's type dementia
- Experience delusions and/or hallucinations
- Have a caregiver/partner who is willing and able to participate in visits and oversee compliance
View study on ClinicalTrials.gov