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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

ADEPT-2 Trial Summary

This trial evaluates a new drug to treat Alzheimer's with psychosis in patients aged 55-90. Its aim is to measure the drug's effectiveness in treating these symptoms.

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.Check my eligibility

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.See study design

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.

ADEPT-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

ADEPT-2 Trial 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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and end of treatment (up to 14 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score

Secondary outcome measures

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

ADEPT-2 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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Karuna TherapeuticsLead Sponsor

12 Previous Clinical Trials

3,006 Total Patients Enrolled

Paul Yeung, MD, MPHStudy DirectorKaruna Therapeutics, Inc.

2 Previous Clinical Trials

680 Total Patients Enrolled

Ronald Marcus, MDStudy DirectorKaruna Therapeutics, Inc.

4 Previous Clinical Trials

1,051 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration accepted KarXT as a viable clinical option?

"We rate KarXT's safety as a 3, since there is evidence of efficacy and numerous studies that have established its safety profile."

Answered by AI

What are the various sites where this medical trial is being conducted?

"Currently, this clinical study is being conducted in 10 different medical centres. These sites are located throughout Chandler, Anaheim and Lafayette with additional locations to choose from. To limit travel demands it is best to select the closest clinic when enrolling for participation."

Answered by AI

Is the age criterion for enrollment into this research project limited to those under 35?

"This particular medical trial is geared towards patients aged 55 to 90. Conversely, there are 137 clinical trials designed for minors and 821 for people over 65 years old."

Answered by AI

Can I qualify for the research project?

"To qualify for this trial, individuals must be between the ages of 55 and 90 AND have Alzheimer's disease. The total number of participants sought is 400."

Answered by AI

Is this clinical trial actively enrolling new participants?

"Affirmative. Clinicaltrials.gov documents show that this clinical trial, which was first publicized on November 1st 2023, is presently recruiting participants. 400 prospective patients are needed from 10 separate medical sites."

Answered by AI

How many participants are recruited for this clinical research?

"Affirmative, clinicaltrials.gov has evidence that this medical experiment is actively seeking out patients for recruitment. It was initially uploaded on November 1st of 2023 and last modified on the 8th of November in the same year. 400 individuals will be involved across 10 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease

2023. "A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06126224.

All > Alzheimers Disease Miami > Tucson