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This study focuses on caregivers and their loved ones living with Alzheimer’s-related psychosis. Key eligibility criteria include:
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Age 55 to 90: The patient (your loved one) is between 55 and 90 years old .
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Diagnosis of Alzheimer’s Disease: The patient has mild to severe Alzheimer’s disease and is experiencing moderate to severe psychosis (for example, troubling hallucinations or delusions) .
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Persistent Symptoms: Psychotic symptoms have been present for at least 2 months or more prior to screening .
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Caregiver Involvement: Each participant will need a dedicated study partner—typically a caregiver—who can attend all study visits, help monitor medication use, provide updates on the participant’s well-being, and assist with completing questionnaires.
Having a consistent study partner is essential to ensure both safety and support throughout the study.
Potential access to the investigational drug that may help manage psychosis associated in Alzheimer's patients.
All study medication, clinic visits, lab tests, and procedures are provided free of charge. While improvement can’t be guaranteed, this study gives access to an investigational treatment (KarXT). Earlier research on the active component of KarXT, it has shown potential in reducing psychosis symptoms such as hallucinations and delusions in individuals with Alzheimer’s disease. Your loved one might experience relief from these symptoms, which could improve their quality of life and ease the caregiving burden.
Close care and monitoring from an Alzheimer's Disease specialist.
Your loved one will receive care at no cost from a local neurologist, a neuropsychologist, and experienced research staff who specialize in neurodegenerative disorders. This includes thorough health check-ups, memory assessments, and close monitoring of their condition throughout the study. Many caregivers find that being in a study provides extra support and medical attention for their loved one. We understand caregivers need care too, so we’ll provide information on caregiver support groups and strategies if desired.
Reimbursement for study-related time and travel expenses.
All study medication, clinic visits, lab tests, and procedures are provided free of charge. The study’s sponsor (Karuna Therapeutics) covers the costs – insurance is not required. Additionally, the study team can connect you with local Alzheimer’s support resources. Your family’s experience could lead to an approved treatment in the future that helps countless other families. Many caregivers find empowerment and hope in taking action against the disease.
Visits, Timeline & Support
Participating in ADEPT-4 means you and your loved one will be closely supported by our team throughout the study. Here’s an overview of the study schedule and commitment:
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Study Duration: ~20 weeks (about 5 months in total). This includes a screening period, a 14-week treatment period, and a follow-up check.
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Number of Visits: Approximately 13 in-clinic visits over the 5 months (about 2–3 visits per month on average). This covers initial screening visits, regular monitoring visits during the 14-week treatment, and one follow-up visit about 2 weeks after treatment .
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Screening (Weeks 0–4): First, the study team will conduct health assessments over up to 30 days to confirm eligibility . This may involve memory/cognitive tests, physical exam, and discussing medical history. There is no cost for these evaluations.
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Treatment Period (14 Weeks): If eligible, your loved one will enter the treatment phase lasting 14 weeks (about 3½ months) . During this time, they will take either KarXT or placebo daily. Regular clinic visits (approximately every one to two weeks) will be scheduled to monitor their health and progress. At each visit, the caregiver and patient will meet with our study doctor and staff for check-ups, fill out questionnaires about symptoms and daily function, and receive the next supply of study medication. Dosing is flexible – the doctor may adjust the dose depending on how well your loved one tolerates the medication and how it’s working . Throughout, you are not alone – our team will check in on your loved one’s safety and answer questions at every step.
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Follow-Up (End of Study): About 2 weeks after the 14-week treatment ends, there will be a final follow-up visit . The study doctor will conduct a last health evaluation to see how your loved one is doing after stopping the study drug. This marks the end of the main study.
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Optional Extension: If the investigational drug seems to be helping and your loved one completes the 14-week study, they may have the option to continue in a 1-year Open-Label Extension (OLE) study . In that extension, all participants receive KarXT (no placebo) so that researchers can gather longer-term safety data and your loved one might continue to benefit from the study medication. Participation in the extension is voluntary and can be discussed upon finishing the main study.
During all these visits, you and your loved one will be treated with the utmost care and respect. Our clinic environment is designed to be comfortable and dementia-friendly, minimizing any stress. If travel or mobility is a concern, let us know – we can assist with accessible transportation arrangements or other accommodations to ensure you can attend visits. All study-related care, exams, and medications are provided at no cost to you. Plus, you may be reimbursed for travel expenses (such as mileage) – ask our team for details.
A New Study Offers Hope for Managing Challenging Behaviors in Alzheimer's.
Recruiting
STUDY BROCHURE - Clinical Research Study for Psychosis- Associated with Alzheimer’s Disease
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