← Back to Search

Other

KarXT for Alzheimer's-Related Psychosis (ADEPT-3 Trial)

Verified Trial

Phase 3

Waitlist Available

Research Sponsored by Karuna Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from initial dose through 14 days after the final dose (up to 54 weeks)

Awards & highlights

ADEPT-3 Trial Summary

This trial will assess the long-term safety and tolerability of KarXT for people with Alzheimer's-related psychosis.

Who is the study for?

This trial is for people aged 55 to 90 with psychosis linked to Alzheimer's who finished the KAR-031 study. They must understand the study, give consent (or have a representative do so), and have a caregiver. Those with severe medical issues or recent significant test abnormalities can't join.Check my eligibility

What is being tested?

The trial tests KarXT's long-term safety and tolerability in treating psychosis in Alzheimer's patients over a year. It’s an extension of a previous study where participants continue receiving KarXT after completing the initial phase.See study design

What are the potential side effects?

While specific side effects are not listed here, generally, this type of medication could cause dizziness, nausea, sleep disturbances, or changes in blood pressure or heart rate among other potential side effects.

ADEPT-3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from initial dose through 14 days after the final dose (up to 54 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from initial dose through 14 days after the final dose (up to 54 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from initial dose through 14 days after the final dose (up to 54 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

Incidence of treatment-emergent adverse events (TEAEs)

Secondary outcome measures

Incidence of TEAEs leading to withdrawal

Incidence of serious TEAEs

ADEPT-3 Trial Design

1Treatment groups

Experimental Treatment

Group I: KarXTExperimental Treatment1 Intervention

Xanomeline and Trospium Chloride Capsules

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Karuna TherapeuticsLead Sponsor

12 Previous Clinical Trials

3,106 Total Patients Enrolled

Paul Yeung, MD, MPHStudy DirectorKaruna Therapeutics, Inc.

2 Previous Clinical Trials

780 Total Patients Enrolled

Ronald Marcus, MDStudy DirectorKaruna Therapeutics, Inc.

4 Previous Clinical Trials

1,151 Total Patients Enrolled

Media Library

KarXT (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05980949 — Phase 3

Alzheimer's Disease Research Study Groups: KarXT

Alzheimer's Disease Clinical Trial 2023: KarXT Highlights & Side Effects. Trial Name: NCT05980949 — Phase 3

KarXT (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05980949 — Phase 3

Frequently Asked Questions

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

Are there still opportunities to join this clinical trial?

"Clinicaltrials.gov states that the recruitment phase for this research has been concluded, as the first listing was posted on July 11th 2023 and last updated on July 31st of the same year. Nonetheless, 960 other studies are currently searching for volunteers across various medical centres."

Answered by AI

Could persons aged sixty and above take part in this exploratory project?

"This clinical trial adheres to strict age criteria; the minimum being 55 and maximum 90."

Answered by AI

Has the KarXT drug been given authorization from the FDA?

"KarXT is judged to be a safe intervention with a score of 3, due to the existence of prior clinical evidence on both efficacy and safety."

Answered by AI

Who meets the qualifications to take part in this study?

"To be selected for this clinical trial, participants must have been diagnosed with Alzheimer's disease and possess an age within the range of 55 to 90 years old. In total, there are 140 spots available in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease

2023. "Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05980949.