Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
Recruiting · Phase 3 · NCT05980949
Conditions: Psychosis Associated With Alzheimer's Disease
At a glance
- Research payments reported, 2025
- $10.4M
- U.S. investigators named
- 90
- Sites paid
- 82
- Planned or actual enrollment
- 1,000
About the trial
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Tested
- KarXT (drug)
- Dates
- Started 2023-07-11; completion 2027-09-07
- Results posted
- Not yet
This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.
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 $10.4M in research payments for this study in 2025 (107 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
- Pallavi Joshi Psychiatry · Phoenix, AZ
- Hemant K. Pandey, MD Neurology · Chandler, AZ
- Muhammad O. Salim Khan Sports Medicine · Gilbert, AZ
- Evagelos Coskinas, M.D. Psychiatry · Costa Mesa, CA
- Ashley Duzik, DO Family Medicine · Tarzana, CA
- Tarek Ezzeddine, MD Internal Medicine · Rancho Cucamonga, CA
- Clifford R. Feldman, M.D, J.D., M.F.S. Psychiatry · Tarzana, CA
- Ira Glick Psychiatry · Stanford, CA
- Steven Macina, DO Psychiatry · Huntington Beach, CA
- M. L. Purino, M.D. Neurology · Arcadia, CA
- Lon Schneider, MD Psychiatry · Los Angeles, CA
- Maria I. Seliverstov, M.D. Psychiatry · Sherman Oaks, CA
- Susan M. Smiga, M.D. Psychiatry · Sacramento, CA
- Frank C. Alvarez Li, M.D. General Practice · Hialeah, FL
- Emelina A. Arocha, M.D. Psychiatry · Miami, FL
- Sadaf Bazargan, MD Neurology · Lutz, FL
- Jorge Betancourt, MD Psychiatry · Mia, FL
- David Billmeier, MD Family Medicine · Daytona Beach, FL
- Angel M. Carrasco, M.D. Neurology · Miami, FL
- John R. Cintron, M.D Neurology · Miami, FL
- Lucinda I. Cuervo, MD General Practice · Miami, FL
- Manuel F. Fernandez, MEDICAL DOCTOR General Practice · Miami, FL
- Marta R. Fernandez, M.D. General Practice · Hollywood, FL
- Christopher M. Galloway, MD Family Medicine · Melbourne, FL
- Jose E. Gamez, M.D Psychiatry · Hialeah, FL
- Amnerys R. Garcia, M.D Neurology · Hialeah, FL
- Nelson Gonzalez, MD Family Medicine · Miami, FL
- Jorge A. Gonzalez JR., M.D. Sports Medicine · Fort Lauderdale, FL
- Cesar E. Guerrero, MD Neurosurgery · Miami, FL
- Roberto A. Hernando, MD Psychiatry · 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
- William A. Justiz, MD Neurology · Naples, FL
- Brandon Lenox, D.O. Anesthesiology · Maitland, FL
- Ramon Leon, MD Family Medicine · Miami, FL
- Delores Macksoud, MD Neurology · Miami, FL
- Daniel F. Mandri, MD Psychiatry · Miami, FL
- Emilio Mantero Atienza, MD Psychiatry · Miami Beach, FL
- Nancy N. Navarro Gonzalez, MD Psychiatry · Miami, FL
- Mohammad Asim Nisar, MD Psychiatry · Okeechobee, 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
- Michael M. Pfeffer, MD Neurology · Miami, 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
- Maria Rodil, M.D. Psychiatry · West Miami, FL
- Jennifer Springer, MD Emergency Medicine · Fort Myers, FL
- Kelly N. Taylor, M.D. Family Medicine · Ocoee, FL
- Antonio E. Terrelonge, MD Family Medicine · Miami, FL
- Beatriz E. Triana, MD Emergency Medicine · Miami, FL
- Pilar F. Trueba, MD Family Medicine · Doral, FL
- Gretel Trullenque, D.O. Family Medicine · Miami, FL
- Heber L. Varela, M.D. Neurology · Miami, FL
- Brian Villa, M.D. Psychiatry · Miami, FL
- Timothy J. Wierzbicki, MD Neurology · Port Orange, FL
- Paul K. Winner, D.O. Child Neurology · West Palm Beach, FL
- Vasundhara Cheekati, M.D. Hospitalist · Lawrenceville, GA
- John C. Morgan, MD Neurology · Augusta, GA
- Mohamed K. Ghumra, MD Neurology · Elgin, IL
- Angela N. Traylor, M.D. Neurology · New Orleans, LA
- Mushtaque A. Chachar, MD Neurology · New Bedford, MA
- Brent P. Forester, M.D. Psychiatry · Belmont, MA
- Arkadiy Stolyar, M.D. Psychiatry · Belmont, MA
- Muhammad A. Khan, M.D. Neurology · Rochester Hills, MI
- Eric J. Carbonell, M.D. Psychiatry · Festus, MO
- Mohammad R. Bolouri, MD Neurology · Matthews, NC
- Sanjiv K. Sharma, M.D. Internal Medicine · Toms River, NJ
- Yordan Orive Gomez, MD Internal Medicine · Artesia, NM
- Jeremy Koppel, MD Psychiatry · Glen Oaks, NY
- David G. Steiner, M.D. Neurology · Woodmere, NY
- Douglas W. Scharre, MD Neurology · Columbus, OH
- Marvin L. Peyton, M.D. Psychiatry · Oklahoma City, OK
- Ileana M. Fumero, M.D. Psychiatry · San Juan, PR
- Ivonne Z. Jimenez-velazquez, MD, FACP Geriatric Medicine · Carolina, PR
- Ismael Toro Grajales, MD, MPH Geriatric Medicine · Bayamon, PR
- Chuang-kuo Wu, M.D., PHD Neurology · Providence, RI
- Jo E. Wilson, M.D. Psychiatry · Nashville, TN
- Nelson A. Berrios, M.D. Neurology · Houston, TX
- Harpaul S. Gill, MD Neurology · Cypress, TX
- Sejal S. Mehta, M.D. Psychiatry · Plano, TX
- Mustafa H. Zaidi, MD Psychiatry · Richmond, TX
- Henry A. Tran, M.D. Cardiology · Falls Church, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Elias Research Associates Llc $3.6M
- Clinitiative Health Research $733,152
- Integrity Clinical Research $639,493
- Mplusm Consulting Llc $614,025
- Future Care Solution, Llc $599,495
- Medone Clinical Research $538,136
- Allied Biomedical Research Institute $317,836
- Pharmaseek $302,140
- Betancourt Research Services $245,460
- Homestead Associates in Research, Inc $180,487
- Floridian Neuroscience Institute $180,034
- Ocean Blue Medical Research Center, Incorporated $157,477
- Guardian Angel Research Center $145,339
- Coral Clinic Research $141,994
- Premier Clinical Research Institute $140,266
- Horizon Clinical Research Group $131,517
- Meridian International Research, Inc $119,971
- On Health Research $110,651
- Imic Research $95,300
- Novel Clinical Research Center, Llc $78,486
- San Marcus Research Clinic, Inc $66,023
- Galiz Research, Llc $62,358
- Direct Helpers Research Center $55,709
- Erg Holding Company Llc $55,070
- Reliant Medical Research $54,967
- Las Mercedes Medical Research - 4440 West 16th Avenue $54,179
- Sc3 Research Group, Inc $53,709
- K2 Medical Research - Maitland $51,859
- Ccm Clinical Research Group $49,251
- Noir Research Collective Llc $48,839
- New Gen Health and Research Group $42,538
- Superior Associates in Research Llc $34,965
- $33,039
- Ohio State University Resear Fo $33,024
- Revival Research Institute, Inc $33,000
- Us Associates in Research, Llc $28,068
- High Quality Research $27,692
- Sunwise Clinical Research $27,278
- Clinical Trial Network, Llc $26,485
- Angels Clinical Research Institute Tampa - PAlm Springs - Ppds $25,499
- Envision Trials, Llc $25,108
- Long Beach Research Institute $25,044
- Banner Casa Grande Medical Center, AZ $24,100
- Advanced Research Center $22,767
- Nexus Clinical Research Center- Nrc $22,755
- K2 Medical Research - Winter Garden $21,599
- Conquest Research, Llc $20,923
- Rhode Island Hospital, RI $20,500
- The Feinstein Institute for Medical Research $19,760
- Arrow Clinical Trials $19,076
- Five Towns Neurology, PC $18,755
- Barbara Diaz Hernandez, MD Research, Inc $18,488
- Alzheimers Memory Center Flourish Research $18,381
- Prospective Research Innovations, Inc $15,000
- Premiere Research Institute $15,000
- Recinto De Ciencias Medical $14,500
- Mclean Hospital Corporation, MA $14,450
- The Ima Group $14,000
- Chandler Clinical Research Trials $14,000
- Aim Trials $13,657
- Clincloud Llc $13,341
- Interspond, Llc $13,050
- Agile Clinical Research Trials $11,500
- California Neuroscience Research Medical Group, Inc $11,344
- Usc Norris Cancer Hospital $10,500
- M3 Wake Research $6,600
- Georgia Health Sciences University $6,500
- Mdfirst Research $6,100
- University Clinical Research - Deland, Llc $3,095
- Health Synergy Clinical Research $1,180
- Vanderbilt Psychiatric Hospital $486
- Aqualane Clinical Research $337
- Cordova Research Institute $336
- Elixia Health - Springfield - Elixia - Ppds $277
- Tufts Medical Center - 800 Washington St - Ppds $236
- Precise Research Center $204
- Conquest Research - Arlington $182
- Usc - the Memory and Aging Center (mac) - Alzheimer Disease Research Center (adrc) $182
- Boston Neuro Research Center $164
- Sensible Healthcare, Llc $139
- Rivus Wellness and Research Institute $125
- Advanced Memory Research Institute of New Jersey $51
- Cdt Grupo Medico San PAblo $39
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.