ADEPT-4:
An Alzheimer's Disease Research Study
Researchers at McLean Hospital are conducting a clinical research study for those with psychosis associated with Alzheimer’s disease.
Fast Facts
Ages 55-90 with Alzheimer's Disease
Psychotic Symptoms for At Least 2 Months
Compensation Provided
Conducted in Belmont, MA
Study Background
This study is being conducted to evaluate the safety and effectiveness of an investigational drug (KarXT) for treating psychosis in individuals with Alzheimer’s disease.
Current treatment options for psychosis associated with Alzheimer’s disease include antipsychotics, which come with a black box warning (indicating serious safety risks) and significant side effects. Our research team is searching for safer treatment options.
This study is focused on a drug called KarXT, which received approval for schizophrenia in September of 2024. The safety profile of KarXT is more favorable and does not come with a black box warning.
We hope to eventually gain FDA approval for KarXT as a treatment for psychosis associated with Alzheimer’s disease. Find out if you or someone you’re caring for can be part of our research efforts today.
Study Background
This study is being conducted to evaluate the safety and effectiveness of an investigational drug (KarXT) for treating psychosis in individuals with Alzheimer’s disease.
Current treatment options for psychosis associated with Alzheimer’s disease include antipsychotics, which come with a black box warning (indicating serious safety risks) and significant side effects. Our research team is searching for safer treatment options.
This study is focused on a drug called KarXT, which received approval for schizophrenia in September of 2024. The safety profile of KarXT is more favorable and does not come with a black box warning.
We hope to eventually gain FDA approval for KarXT as a treatment for psychosis associated with Alzheimer’s disease. Find out if you or someone you’re caring for can be part of our research efforts today.
Additional Information
The ADEPT-4 Study will test how effective and safe a study medication, KarXT, may be in people experiencing psychosis related to Alzheimer’s disease. KarXT targets the M1 and M4 receptors, which is a new and different way of treating psychosis. Our eventual goal is to establish safer treatment options to improve the lives of individuals with AD as well as their caregivers.
You or someone you are caring for may qualify for this study if you meet the following criteria.
Inclusion Criteria:
- Ages 55-90
- Diagnosed with Alzheimer’s disease
- History of psychotic symptoms associated with Alzheimer’s Disease for at least 2 months
- Have a caregiver who can accompany you to study visits
Exclusion Criteria:
- Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
- Psychotic symptoms can be attributed to another disorder besides Alzheimer’s disease
This is a 14-week in-person clinical trial involving an investigational drug, KarXT.
Participants will go through a screening period to be determined eligible. During this screening period, participants will come in-person for a study visit.
If eligible for the study, participants will be asked to take either the study drug or a placebo (an inactive substitute) for 14 weeks. Over these 14 weeks, there are 8 in-person visits and 3 phone/virtual visits.
During these visits, participants will be asked to:
- Do mental health and cognitive assessments
- Give medical history
- Receive a physical exam, ECG, blood draws, and/or urinalysis
Participants will be compensated up to $750 for completing the entire study. Additional compensation for travel reimbursement and meals is available for each visit.
There is no cost to participate in our research study.
