Recruiting NCT06976203

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)

Phase III Interventional Alzheimer's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: KarXT, KarX-EC, Placebo.
Who it may be relevant to: Registry conditions: Alzheimer's Disease. Basic parameters: 60 years — 85 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Finland +12
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated With Mild to Moderate Alzheimer's Disease (MINDSET 2)

Overview

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Interventions

Drug KarXT
Specified dose on specified days
Drug KarX-EC
Specified dose on specified days
Other Placebo
Specified dose on specified days

Primary outcome measures

Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) [Time frame: At week 24]
Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+) [Time frame: At week 24]

Secondary outcome measures (12)

Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL) [Time frame: At week 24]
Change from baseline in neuro psychiatric inventory (NPI) total score [Time frame: At week 24]
Number of participants with adverse events (AEs) [Time frame: At week 24]
Number of participants with serious adverse events (SAEs) [Time frame: At week 24]
Number of participants with adverse event of special interest (AESIs) [Time frame: At week 24]
Number of participants with AEs leading to study intervention discontinuation [Time frame: At week 24]
Number of participants with AEs leading to study discontinuation [Time frame: At week 24]
Number of participants with AEs leading to death [Time frame: At week 24]
Number of participants with clinically significant changes in vital signs [Time frame: At week 24]
Number of participants with clinically significant changes in electrocardiogram (ECG) tests [Time frame: At week 24]
Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS) tests [Time frame: At week 24]
Number of participants with clinically significant changes in weight [Time frame: At week 24]

Eligibility criteria

Inclusion criteria

Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.
Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.
Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities.
Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.

Exclusion criteria

Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of <50 mL/min), and unstable hypertension or tachycardia.

Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.
Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.
Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that could affect safety or interfere with study procedures.
Other protocol-defined Inclusion/Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

United States · 30 centers

Fullerton Neurology and Headache Center — Fullerton
Irvine Clinical Research — Irvine
Inglewood Clinical — Los Angeles
Stanford Neuroscience Health Center — Palo Alto
Local Institution - 0069 — San Diego
Research of the Rockies — Colorado Springs
Neuropsychiatric Research Center of Southwest Florida — Fort Myers
Local Institution - 0086 — Hallandale
… and 22 more centers

Japan · 15 centers

Inage Neurology and Memory Clinic — Inage
Local Institution - 0123 — Matsudo
Imon Yukari Neurology Clinic — Hiroshima
… and 12 more centers

France · 14 centers

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone — Marseille
Local Institution - 0128 — Tours
Centre Hospitalier Universitaire Toulouse - Cité de la Santé — Toulouse
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro — Lille
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou — Rennes
Local Institution - 0127 — Saint-Herblain
Centre Hospitalier Universitaire Régional de Nancy — Nancy
Hospices Civils de Lyon - Hôpital Pierre Wertheimer — Bron
… and 6 more centers

United Kingdom · 8 centers