KarXT for Alzheimer's-Related Psychosis
(ADEPT-2 Trial)
Recruiting in Palo Alto (17 mi)
+159 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Karuna Therapeutics
Disqualifiers: Bipolar, Schizophrenia, Major depression, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This trial is testing KarXT, a medication for adults aged 55-90 with Alzheimer's Disease and severe psychosis. The goal is to see if KarXT can reduce symptoms like hallucinations and delusions by balancing brain chemicals.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
How is the drug KarXT different from other drugs for Alzheimer's-related psychosis?
KarXT is unique because it combines two components, xanomeline and trospium chloride, which work together to target specific brain receptors involved in psychosis, potentially offering a different mechanism of action compared to traditional antipsychotics like aripiprazole and haloperidol. This combination aims to reduce side effects commonly associated with other treatments, such as cognitive decline and movement disorders.
12345Eligibility Criteria
This trial is for men and women aged 55 to 90 with mild to severe Alzheimer's Disease who experience moderate to severe psychosis. Participants must understand the study, have a caregiver interacting with them at least 10 hours weekly, and meet specific criteria for psychotic symptoms and cognitive assessment scores.Inclusion Criteria
Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening
I have someone who can be with me for at least 10 hours a week.
I have Alzheimer's with strong hallucinations or delusions.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive KarXT or placebo for the treatment of psychosis associated with Alzheimer's Disease
14 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing KarXT against a placebo in individuals with Alzheimer's-related psychosis. It aims to see if KarXT can better reduce hallucinations and delusions compared to a non-active treatment. The effectiveness will be measured using the NPI-C: Hallucinations and Delusions score.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: KarXTExperimental Treatment1 Intervention
Xanomeline and Trospium Chloride Capsules
Group II: PlaceboPlacebo Group1 Intervention
Placebo Capsules
KarXT is already approved in United States for the following indications:
🇺🇸 Approved in United States as Cobenfy for:
- Schizophrenia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Clinical Trial SiteMiami, FL
Clinical Trial SiteTampa, FL
Clinical Trial SiteMiami Gardens, FL
MDFirst Research-ChandlerChandler, AZ
More Trial Locations
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Who Is Running the Clinical Trial?
Karuna TherapeuticsLead Sponsor
References
Aripiprazole for the treatment of psychoses in institutionalized patients with Alzheimer dementia: a multicenter, randomized, double-blind, placebo-controlled assessment of three fixed doses. [2022]To assess the efficacy and safety of aripiprazole for psychosis associated with Alzheimer dementia (AD).
A randomized, double-blind, placebo-controlled study of aripiprazole for the treatment of psychosis in nursing home patients with Alzheimer disease. [2022]To evaluate the efficacy and safety of aripiprazole treatment for psychotic symptoms associated with Alzheimer disease (AD).
A pilot study of haloperidol treatment of psychosis and behavioral disturbance in Alzheimer's disease. [2019]Nine outpatients meeting research criteria for probable Alzheimer's disease who had psychosis or behavioral disturbance participated in a single-blind, placebo-controlled pilot study. Oral haloperidol in doses of 1 to 5 mg daily improved target symptoms, confirmed by double-blind ratings of videotaped interviews. Patients could not be maintained on more than 4 mg of haloperidol daily due to the severity of extrapyramidal side effects. Modified Mini-Mental State scores worsened while taking haloperidol, with only partial recovery in the final 4-week placebo phase. Severe extrapyramidal side effects and decline in cognitive function may compromise the efficacy of commonly used doses of neuroleptic drugs in patients with Alzheimer's disease.
Effects of Vitamin D Use on Outcomes of Psychotic Symptoms in Alzheimer Disease Patients. [2020]To identify medications that may prevent psychosis in patients with Alzheimer disease (AD).
Aripiprazole for the treatment of psychosis in patients with Alzheimer's disease: a randomized, placebo-controlled study. [2022]This study compared the efficacy, safety, and tolerability of aripiprazole, a novel antipsychotic, with placebo in patients with psychosis associated with Alzheimer's Disease (AD). This 10-week, double-blind, multicenter study randomized 208 outpatients (mean age, 81.5 years) with AD-associated psychosis to aripiprazole (n = 106) or placebo (n = 102). The initial aripiprazole dose of 2 mg/d was titrated upwards (5, 10, or 15 mg/d) according to efficacy and tolerability. Evaluations included Neuropsychiatric Inventory (NPI) Psychosis subscale and Brief Psychiatric Rating Scale (BPRS), adverse event (AE) reports, extrapyramidal symptoms (EPS) rating scales, and body weight. Overall, 172 patients (83%) completed the study. Mean aripiprazole dose at end point was 10.0 mg/d. The NPI Psychosis subscale score showed improvements in both groups (aripiprazole, -6.55; placebo, -5.52; P = 0.17 at end point). Aripiprazole-treated patients showed significantly greater improvements from baseline in BPRS Psychosis and BPRS Core subscale scores at end point compared with placebo. AEs were generally mild to moderate in severity and included (aripiprazole vs. placebo): urinary tract infection (8% vs. 12%), accidental injury (8% vs. 5%), somnolence (8% vs. 1%), and bronchitis (6% vs. 3%). Somnolence was mild and not associated with falls or accidental injury. There were no significant differences from placebo in EPS scores, or clinically significant ECG abnormalities, vital signs, or weight. In conclusion, aripiprazole showed similar improvements to placebo in psychotic symptoms as assessed by NPI Psychosis subscale scores, but significantly greater effects on BPRS Core and Psychosis assessments in community-living AD patients with psychosis. Aripiprazole was safe and well tolerated in this patient population.