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KarXT for Alzheimer's-Associated Psychosis (ADEPT-1 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
Is aged 55 to 90 years, inclusive, at Screening
Meets clinical criteria for possible or probable Alzheimer's Disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 38
Awards & highlights
ADEPT-1 Trial Summary
This trial is testing if a new medication can prevent relapse in people with Alzheimer's disease and psychosis.
Who is the study for?
This trial is for people aged 55-90 with Alzheimer's-related psychosis, able to move independently (with or without aid), and have a caregiver. They must not be pregnant, agree to use contraception if applicable, and have been on stable doses of certain medications for six weeks. Exclusions include recent major depression with psychosis, stroke history within the last year, COVID-19 infection within two weeks before screening, or prior KarXT exposure.Check my eligibility
What is being tested?
The study tests KarXT against a placebo in preventing relapse of psychosis symptoms in Alzheimer's patients over 38 weeks. It's randomized and double-blind meaning neither participants nor researchers know who gets the real treatment versus placebo until after the results are collected.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones may include digestive issues, dizziness or sedation due to brain activity changes from KarXT. Participants will be monitored closely for any adverse reactions throughout the study.
ADEPT-1 Trial 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 have been diagnosed with early or probable Alzheimer's Disease.
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I am between 55 and 90 years old.
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I have been diagnosed with early or probable Alzheimer's Disease.
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I experience moderate to severe delusions or hallucinations.
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I am not pregnant or breastfeeding and willing to use effective birth control during and after the study.
ADEPT-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 38
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 38
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time from randomization to relapse during the 38-week study
Secondary outcome measures
Time from randomization to discontinuation for any reason during the 38-week study
ADEPT-1 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
Find a Location
Who is running the clinical trial?
Karuna TherapeuticsLead Sponsor
12 Previous Clinical Trials
3,026 Total Patients Enrolled
Paul Yeung, MD, MPHStudy DirectorKaruna Therapeutics
2 Previous Clinical Trials
700 Total Patients Enrolled
Paul Yeung, MDStudy DirectorKaruna Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have any of the following conditions: heart problems, liver diseases, high risk for urinary retention, narrow-angle glaucoma, or serious constipation in the last 6 months. You also have a history or high risk of long QT syndrome, or have a positive urine test for certain substances without medical approval. Additionally, you have an implantable cardiac defibrillator, or have had a heart attack within the last 6 months. You may also be excluded if you have a history of irritable bowel syndrome, show signs of suicidal behavior, have any abnormal physical examination or laboratory results during screening, or have HIV.I can visit the clinic as needed and follow all study instructions.I cannot stop taking a medication that would interfere with the study.I've been on a stable dose of my Alzheimer's medication for 6 weeks.I have previously been treated with KarXT.You are living at the same home or residential assisted-living facility for a minimum of six weeks before Screening.My dementia is not mainly due to a mental health condition like schizophrenia.I have had serious side effects from trospium.I am not pregnant or breastfeeding and willing to use effective birth control during and after the study.I have not had a stroke or bleeding in the brain in the last year.I have been on a stable dose of SSRIs or SNRIs for at least 8 weeks.I have been using Mirtazapine for sleep for at least 8 weeks.I understand the study and can sign the consent form myself.I have been diagnosed with early or probable Alzheimer's Disease.I've had a brain scan within the last 5 years to check for causes of dementia.I have never been diagnosed with delirium, amnesia, bipolar disorder, schizophrenia, or schizoaffective disorder.I have recently taken certain medications for mental health conditions.I am between 55 and 90 years old.I can attend all appointments and provide updates on my health.I am between 55 and 90 years old.I have had a brain scan within the last 5 years to check for causes of dementia.I have had a severe depression with psychosis in the last year.I experience moderate to severe delusions or hallucinations.I can move on my own or with help, and have a caregiver willing to assist with the study.You have experienced symptoms of a mental illness called psychosis for at least 2 months before being screened.I have been diagnosed with early or probable Alzheimer's Disease.I have never had brain blood vessel issues, seizures, brain tumors, unstable thyroid, or fainting spells without a known cause.
Research Study Groups:
This trial has the following groups:- Group 1: KarXT
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are participating in this research trial?
"Yes, the data on clinicaltrials.gov says that this trial is actively seeking candidates. The study was first posted on 8/23/2022 and was most recently updated on 11/3/2022. The trial is enrolling 380 patients between 3 sites."
Answered by AI
Are there any available participant openings in this clinical trial?
"According to the information available on clinicaltrials.gov, this trial is currently recruiting patients. The study was first posted on 8/23/2022 and was most recently updated on 11/3/2022."
Answered by AI
Is this clinical trial open to people who are over 18 years of age?
"In order to be considered for this clinical trial, applicants must between the ages of 55 and 90. Out of the 1,183 total trials taking place, 152 are for people under 18 years old and 1031 are for seniors above the age of 65."
Answered by AI
Who might this clinical trial be most beneficial for?
"The aim of this clinical trial is to test a new intervention for Alzheimer's disease in patients aged 55-90. Around 380 individuals are needed for the study."
Answered by AI
Is KarXT a danger to human health?
"KarXT has been shown to be safe in multiple clinical trials, so it received a score of 3 from our team at Power."
Answered by AI
Who else is applying?
What state do they live in?
California
Florida
How old are they?
18 - 65
What site did they apply to?
Other
Clinical Trial Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I'm looking for some relief and hope this will help.
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Clinical Trial Site: < 48 hours
Average response time
- < 2 Days
Typically responds via
Phone Call
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