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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
Must not have
Psychotic symptoms that are primarily attributable to a condition other than the Alzheimer's Disease causing dementia e.g., schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features
History of major depressive episode with psychotic features during the 12 months prior to Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 38
Awards & highlights
Pivotal Trial
Summary
This trial is testing KarXT, a medication, to see if it can prevent psychotic symptoms from returning in people with Alzheimer's Disease. It works by balancing brain chemicals that cause hallucinations and delusions. KarXT has shown positive results in reducing symptoms of schizophrenia.
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My dementia is not mainly due to a mental health condition like schizophrenia.
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I have had a severe depression with psychosis in the last year.
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I have never been diagnosed with delirium, amnesia, bipolar disorder, schizophrenia, or schizoaffective disorder.
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I have not had a stroke or bleeding in the brain in the last year.
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I have never had brain blood vessel issues, seizures, brain tumors, unstable thyroid, or fainting spells without a known cause.
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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.
Select...
I have previously been treated with KarXT.
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I have had serious side effects from trospium.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 38
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 38
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time from randomization to relapse during the 38-week study
Secondary study objectives
Time from randomization to discontinuation for any reason during the 38-week study
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 include cholinesterase inhibitors, memantine, and muscarinic receptor agonist and antagonist combinations like KarXT. Cholinesterase inhibitors increase acetylcholine levels to improve nerve cell communication, while memantine regulates glutamate activity to prevent nerve cell damage.
The muscarinic receptor agonist and antagonist combination aims to modulate the cholinergic system more precisely, potentially offering better symptom control with fewer side effects. These treatments are essential as they address neurotransmitter imbalances and neuronal damage, aiming to enhance cognitive function and quality of life for Alzheimer's patients.
Find a Location
Who is running the clinical trial?
Karuna TherapeuticsLead Sponsor
15 Previous Clinical Trials
3,610 Total Patients Enrolled
Paul Yeung, MDStudy DirectorKaruna Therapeutics
Paul Yeung, MD, MPHStudy DirectorKaruna Therapeutics
2 Previous Clinical Trials
700 Total Patients Enrolled
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.
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