A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
Recruiting · Phase 3 · NCT06126224
Conditions: Psychosis Associated With Alzheimer's Disease
At a glance
- Research payments reported, 2025
- $4.6M
- U.S. investigators named
- 54
- Sites paid
- 40
- Planned or actual enrollment
- 500
About the trial
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Tested
- KarXT (drug), Placebo (drug)
- Dates
- Started 2023-08-28; completion 2026-12-09
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-10-16. Full record, eligibility and contacts (opens in a new tab)
Industry funding
E.r. Squibb & Sons, L.l.c. reported $4.6M in research payments for this study in 2025 (59 payments).
Products named: Cobenfy
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Danielle Cabral, MD Neurology · Phoenix, AZ
- Leon Barkodar, M.D. Neurology · West Hills, CA
- Ira Glick Psychiatry · Stanford, CA
- Steven Macina, DO Psychiatry · Huntington Beach, CA
- David A. Rosenberg, M.D. Neurology · Los Alamitos, CA
- Maria I. Seliverstov, M.D. Psychiatry · Sherman Oaks, CA
- Sadaf Bazargan, MD Neurology · Lutz, FL
- Jorge Betancourt, MD Psychiatry · Mia, FL
- Deborah A. Burke, MD Neurology · Tampa, FL
- Angel M. Carrasco, M.D. Neurology · Miami, FL
- Lucinda I. Cuervo, MD General Practice · Miami, FL
- Marta R. Fernandez, M.D. General Practice · Hollywood, FL
- Manuel F. Fernandez, MEDICAL DOCTOR General Practice · Miami, FL
- Jose E. Gamez, M.D Psychiatry · Hialeah, FL
- Amnerys R. Garcia, M.D Neurology · Hialeah, FL
- Cesar E. Guerrero, MD Neurosurgery · Miami, FL
- Sabih Iqbal, MD Psychiatry · Miami, FL
- Thierry O. Jacquemin, DO Internal Medicine · Miami, FL
- Christopher A. Jimenez, M.D. Neurology · South Miami, FL
- Rosemary D. Laird, MD Geriatric Medicine · Viera, FL
- Ayesha S. Lall, MD Child & Adolescent Psychiatry · Gainesville, FL
- Brandon Lenox, D.O. Anesthesiology · Maitland, FL
- Ramon Leon, MD Family Medicine · Miami, FL
- Delores Macksoud, MD Neurology · Miami, FL
- Emilio Mantero Atienza, MD Psychiatry · Miami Beach, FL
- Keiler Moreno Rivero, M.D Internal Medicine · Kissimmee, FL
- Maria T. Nualart, MD General Practice · Miami, FL
- Esteban Olivera, MD Emergency Medicine · Kissimmee, FL
- Suez Oramas Mingo SR., MD Neurology · Miami, FL
- Paayal K. Patel, M.D Neurology · West Palm Beach, FL
- Yanely Pineiro Puebla, M.D. Internal Medicine · Pembroke Pines, FL
- Gonzalo F. Quesada, M.D Psychiatry · Miami Lakes, FL
- Carlos M. Ramirez-calderon, M.D. Neurology · Miami, FL
- Sonia I. Rente, MD General Practice · Miami, FL
- Francisco J. Ricart, MD Psychiatry · Miami, FL
- Al W. Robaina, M.D. Internal Medicine · Apollo Beach, FL
- Roberto H. Ruiz, M.D. Internal Medicine · Miami, FL
- Jennifer Springer, MD Emergency Medicine · Fort Myers, FL
- Pilar F. Trueba, MD Family Medicine · Doral, FL
- Gretel Trullenque, D.O. Family Medicine · Miami, FL
- Brian Villa, M.D. Psychiatry · Miami, FL
- Timothy J. Wierzbicki, MD Neurology · Port Orange, FL
- Kelley A. Wilson, M.D. Psychiatry · Tampa, FL
- Kimball A. Johnson, MD Internal Medicine · Atlanta, GA
- Mohamed K. Ghumra, MD Neurology · Elgin, IL
- Angela N. Traylor, M.D. Neurology · New Orleans, LA
- Muhammad A. Khan, M.D. Neurology · Rochester Hills, MI
- Eric J. Carbonell, M.D. Psychiatry · Festus, MO
- Mohammed Nisar, M.D.PA.FACP Specialist · Edison, NJ
- Joel Vandersluis, M.D. Neurology · Dayton, OH
- Harpaul S. Gill, MD Neurology · Cypress, TX
- Ankit A. Patel, M.D. Neurology · Katy, TX
- Manjeshwar R. Prabhu, MD Psychiatry · Houston, TX
- Mustafa H. Zaidi, MD Psychiatry · Richmond, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Elias Research Associates Llc $1.5M
- Meridian International Research, Inc $354,804
- Mplusm Consulting Llc $310,551
- Future Care Solution, Llc $284,872
- Medone Clinical Research $243,273
- Pharmaseek $227,462
- Integrity Clinical Research $213,877
- Horizon Clinical Research Group $161,155
- K2 Medical Research $151,857
- Floridian Neuroscience Institute $150,928
- Clinitiative Health Research $134,765
- Us Associates in Research, Llc $110,217
- Guardian Angel Research Center $84,558
- Homestead Associates in Research, Inc $65,258
- $63,002
- Superior Associates in Research Llc $59,785
- Ccm Clinical Research Group $50,400
- Imic Research $47,636
- Ecir Miami Holdings Llc $43,374
- Interspond, Llc $37,307
- Reliant Medical Research $35,560
- Elligo Health Research, Inc $29,253
- Advanced Research Center $25,974
- Galiz Research, Llc $23,433
- Clinical Trial Network, Llc $19,550
- Sunwise Clinical Research $16,916
- Cenexel Iresearch Atlanta $15,117
- Direct Helpers Research Center $12,630
- Revival Research Institute, Inc $12,300
- The Ima Group $11,200
- Erg Holding Company Llc $10,627
- Accel Research Sites $9,195
- High Quality Research $8,408
- Health Synergy Clinical Research $5,875
- Wake Research Associates $5,400
- University Clinical Research - Deland, Llc $3,950
- M3 Wake Research $3,682
- Vertex Clinical Research, Llc $3,495
- Clincloud Llc $1,101
- California Neuroscience Research Medical Group, Inc $900
- Tandem Clinical Research $500
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.