What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and NMDA receptor antagonists (memantine). Cholinesterase inhibitors can cause gastrointestinal side effects such as nausea, vomiting, and diarrhea, as well as muscle cramps and fatigue. Memantine may cause dizziness, headache, confusion, and constipation. For treatments similar to KarXT, which involves muscarinic receptor modulation, potential side effects could include dry mouth, blurred vision, constipation, urinary retention, and cognitive disturbances. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to the patient's needs.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Disease, primarily focusing on cholinesterase inhibitors like donepezil and galantamine, which enhance cholinergic function by inhibiting the breakdown of acetylcholine. Another class includes NMDA receptor antagonists like memantine, which modulate glutamatergic activity. While these treatments differ mechanistically from KarXT, which combines muscarinic receptor agonist and antagonist actions, they share the common goal of addressing neurotransmitter imbalances in Alzheimer's Disease.

What other types of research exist?

Promising novel alternatives to KarXT for Alzheimer's Disease patients include: 1) Lecanemab, an anti-amyloid beta protofibril antibody, which has shown positive results in reducing cognitive decline. 2) Donanemab, another anti-amyloid antibody, which has demonstrated potential in slowing disease progression. 3) ALZ-801, an oral agent targeting amyloid beta oligomers, currently in Phase 3 trials. These treatments are expected to be significant options by 2024.

← Back to Search

Other

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 below

Select...

I am between 55 and 90 years old.

Select...

I have been diagnosed with early or probable Alzheimer's Disease.

Select...

I am between 55 and 90 years old.

Select...

I have been diagnosed with early or probable Alzheimer's Disease.

Select...

I experience moderate to severe delusions or hallucinations.

Select...

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.

Select...

I have had a severe depression with psychosis in the last year.

Select...

I have never been diagnosed with delirium, amnesia, bipolar disorder, schizophrenia, or schizoaffective disorder.

Select...

I have not had a stroke or bleeding in the brain in the last year.

Select...

I have never had brain blood vessel issues, seizures, brain tumors, unstable thyroid, or fainting spells without a known cause.

Select...

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.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 38 for reporting.

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

0 / 14Eligibility criteria met

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.