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KarXT for Alzheimer's-Related Psychosis (ADEPT-2 Trial)
Verified Trial
Phase 3
Recruiting
Research Sponsored by Karuna Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female aged 55 to 90 years at Screening
Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and end of treatment (up to 14 weeks)
Awards & highlights
Pivotal Trial
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not specified here, common side effects of treatments like KarXT may include dizziness, nausea, changes in appetite or weight, sleep disturbances, or mood swings. Each person might react differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 55 and 90 years old.
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I understand the trial details and can give informed consent.
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I have been diagnosed with early or likely Alzheimer's disease.
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I have someone who can be with me for at least 10 hours a week.
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I have had symptoms of psychosis for at least 2 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and end of treatment (up to 14 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and end of treatment (up to 14 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
Secondary study objectives
Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) scale
Change from Baseline to End of Treatment in the Cohen-Mansfield Agitation Inventory (CMAI) score
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: KarXTExperimental Treatment1 Intervention
Xanomeline and Trospium Chloride Capsules
Group II: PlaceboPlacebo Group1 Intervention
Placebo Capsules
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Alzheimer's Disease (AD) often target the cholinergic system, amyloid-beta plaques, and tau protein tangles. Cholinesterase inhibitors (e.g., donepezil, rivastigmine) increase acetylcholine levels by inhibiting its breakdown, which can help improve cognitive function.
KarXT, a combination of xanomeline (a muscarinic receptor agonist) and trospium (a muscarinic receptor antagonist), aims to modulate cholinergic neurotransmission to reduce psychosis symptoms in AD patients. Additionally, treatments like anti-amyloid antibodies (e.g., aducanumab) target amyloid-beta plaques to slow disease progression, while tau protein stabilizers aim to prevent neurofibrillary tangles.
These mechanisms are crucial as they address different pathological aspects of AD, potentially improving symptoms and slowing disease progression.
AF710B, a Novel M1/σ1 Agonist with Therapeutic Efficacy in Animal Models of Alzheimer’s Disease.
AF710B, a Novel M1/σ1 Agonist with Therapeutic Efficacy in Animal Models of Alzheimer’s Disease.
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Who is running the clinical trial?
Karuna TherapeuticsLead Sponsor
16 Previous Clinical Trials
3,634 Total Patients Enrolled
Paul Yeung, MD, MPHStudy DirectorKaruna Therapeutics, Inc.
2 Previous Clinical Trials
680 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,582 Previous Clinical Trials
3,388,286 Total Patients Enrolled
Ronald Marcus, MDStudy DirectorKaruna Therapeutics, Inc.
4 Previous Clinical Trials
1,011 Total Patients Enrolled