A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Psychosis Associated With Alzheimer's Disease

In brief

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.

Key facts

Study ID

NCT06126224

Run by

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

People needed

500

Starts

2023-08-28

Expected to finish

2026-12-09

Last updated by the study team

2026-07-30

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Health Synergy Clinical Research,LLC - Stuart — Stuart, Florida, United States (enrolling)
• Local Institution - 6001 — Las Condes, Chile (enrolling)
• Shanghai General Hospital - North Campus — Shanghai, Shanghai Municipality, China (enrolling)
• Local Institution - 1131 — Viera, Florida, United States (enrolling)
• Biomedica Research Group — Providencia, Santiago Metropolitan, Chile (enrolling)
• Psicomed Estudios Medicos — Antofagasta, Chile (enrolling)
• Local Institution - 1106 — Cypress, Texas, United States (enrolling)
• Local Institution - 1117 — Los Alamitos, California, United States
• Local Institution - 1142 — Lancaster, California, United States
• Local Institution - 1104 — Anaheim, California, United States
• Local Institution - 1138 — Cutler Bay, Florida, United States
• Local Institution - 1162 — Delray Beach, Florida, United States
• Local Institution - 1164 — Doral, Florida, United States
• Local Institution - 1165 — Fort Myers, Florida, United States
• Local Institution - 1156 — Clermont, Florida, United States
• Local Institution - 1160 — Apopka, Florida, United States
• Local Institution - 1151 — Encino, California, United States
• Local Institution - 1140 — Hialeah, Florida, United States
• Local Institution - 0150 — Homestead, Florida, United States
• Local Institution - 1145 — Homestead, Florida, United States
• Local Institution - 1127 — Largo, Florida, United States
• Local Institution - 1039 — Maitland, Florida, United States
• Local Institution - 1146 — Maitland, Florida, United States
• Local Institution - 1159 — Miami, Florida, United States
• Local Institution - 1120 — Hialeah, Florida, United States

Full record on ClinicalTrials.gov

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