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The Vanderbilt Center for Cognitive Medicine is recruiting participants for the ADEPT-4 (Alzheimer’s DiseasE Psychosis Treatment program) clinical trial, a global study evaluating KarXT, a treatment for psychosis associated with Alzheimer’s disease.
The effort reflects both the promise of new therapies for patients and families affected by the disease and the challenges researchers face in enrolling participants in clinical trials designed to address critical health care needs.
Vanderbilt Health is one of 97 participating sites across the United States and part of a broader international research network that includes 267 sites in 24 additional countries.
“Psychosis (delusions or hallucinations) affect nearly half of all individuals with Alzheimer’s disease at some point during their disease course, with the prevalence of psychosis increasing with more advanced stages of dementia,” said Jo Ellen Wilson, MD, PhD, MPH, Associate Professor of Psychiatry and Behavioral Sciences and the site principal investigator for the ADEPT-4 trial at Vanderbilt Health. “Psychosis and Alzheimer’s disease co-occur because Alzheimer’s pathology (beta amyloid and tau) directly damages the brain circuits responsible for reality monitoring, sensory processing and belief evaluation.”
KarXT is an oral investigational therapy being evaluated for the treatment of moderate to severe psychosis associated with Alzheimer’s disease. It is a combination of xanomeline and trospium chloride.
“KarXT represents an exciting, novel approach to treating psychosis associated with Alzheimer’s disease because it targets brain pathways involved in these symptoms in a way that differs from many existing treatments,” said Blake Wilson, Associate Program Manager at the Center for Cognitive Medicine. “Hallucinations and delusions can be some of the most challenging and distressing symptoms for individuals living with Alzheimer’s disease and their caregivers.”
The possibility of a new treatment option that may address these symptoms while minimizing unwanted side effects is what makes studies like ADEPT-4 important.
“By potentially improving symptoms of psychosis associated with Alzheimer’s and reducing unwanted side effects like nausea and constipation, newer therapies may offer additional treatment options for patients with this condition,” Wilson said.
To qualify for the study, participants must be between 55 and 90 years old and have a diagnosis of mild to severe Alzheimer’s disease accompanied by moderate to severe psychosis. Participants also must have a caregiver or study partner who can attend all study visits, oversee medication administration and assist with study assessments throughout participation.
While these requirements help researchers evaluate the treatment’s effectiveness and safety, they can also narrow the pool of volunteers. Vanderbilt Health research staff have already prescreened several potential participants, but none have met the eligibility requirements.
“Identifying eligible participants for studies like ADEPT-4 can be especially challenging because there are many factors that must align,” Wilson said. “Participants must meet specific medical criteria, be experiencing the appropriate level of psychosis, and be able to wean off any currently prescribed antipsychotic treatment.
“Although many families are dealing with difficult symptoms like hallucinations, delusions and changes in behavior, they may not realize that clinical research opportunities are available. Our goal is to increase awareness by connecting with families earlier and collaborating with health care providers to determine whether participation in a study like ADEPT-4 may be an option for their patients.”
Researchers say these obstacles are not unique to Alzheimer’s disease studies. Across health care, clinical trials investigating cancer, neurological disorders, cardiovascular disease and other serious conditions frequently encounter recruitment difficulties due to increasingly sophisticated study designs and stringent eligibility criteria.
For participants who qualify, the ADEPT-4 study offers access to study-related care at no cost. Individuals enrolled in the trial can expect a screening period of approximately 30 days, followed by up to 14 weeks of study treatment and a safety follow-up visit four weeks after treatment concludes. All study-related visits, testing and investigational medication are provided at no cost, and reimbursement is available for study-related time and travel expenses. Those interested in learning more about the ADEPT-4 study can contact Beverly Burchfield at the Center for Cognitive Medicine: beverly.burchfield@vumc.org or 615-875-3722.
Download a brochure about the ADEPT-4 study below.
