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GAIN Trial: COR388 for Alzheimer's Disease

Start: April 24, 2019
End: December 31, 2022
Enrollment: 573

What Is This Study About?

This Phase II/III clinical trial will test the efficacy, safety, and tolerability of COR388 in older adults with mild to moderate Alzheimer's disease. Researchers are investigating the drug as a potential treatment for the disease.

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: 80 Years

Must have:

  • Probable Alzheimer's dementia according to the NIA-Alzheimer's Association criteria
  • Mini-Mental State Examination score of 12 to 22
  • Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer's disease; computed tomography scan can be used only if potential participant cannot undergo MRI
  • Modified Hachinski score of 4
  • Use of acetylcholinesterase inhibitors and/or memantine is allowed if dose has been stable for 90 days and no changes are planned during the study
  • Caregiver willing to accept responsibility for supervising the treatment (e.g., administering study drug) and assessing the participant's condition throughout the study
  • Body mass index less than 38

Must NOT have:

  • Imaging results consistent with a dementia diagnosis other than Alzheimer's
  • Increase or restoration of cognition based on medical history
  • History or current evidence of major psychiatric illness, such as schizophrenia, bipolar disorder, or major depressive disorder, that may interfere with the participant's ability to perform the study and assessments; use of antidepressants or anti-epileptic medication for non-seizure-related treatment is allowed if dose has remained stable for at least 60 days prior to enrollment.
  • Any of the following laboratory findings at screening:
    • Alanine aminotransferase greater than 3 times the upper limit of normal (ULN), aspartate aminotransferase greater than 3 times ULN, or history of clinically significant liver disease
    • Hemoglobin less than or equal to 10 g/dl
    • Creatinine clearance of less than 45 ml/min
    • Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) greater than 8
    • Positive blood screen for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab)
 

Who Is the General Study Contact?

For more information, visit the GAIN Alzheimer's Trial website.

Study Contact
Michael J. Detke, MD, PhD

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Arizona
Xenoscience, Inc.
Phoenix, AZ 85004
Banner Alzheimer's Institute
Phoenix, AZ 85006
Banner Sun Health
Sun City, AZ 85351
California
ATP Clinical Research, Inc.
Costa Mesa, CA 92626
Alliance Research
Long Beach, CA 90807
Standford University
Palo Alto, CA 94305
CITRIALS
Riverside, CA 92506
CITRIALS
Santa Ana, CA 92705
Syrentis Clinical Research
Santa Ana, CA 92705
Southern California Research LLC
Simi Valley, CA 93065
Florida
JEM Research Institute
Atlantis, FL 33462
Brain Matters Research
Delray Beach, FL 33445
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, FL 33912
MD Clinical
Hallandale Beach, FL 33009
Indago Research and Health Center, Inc.
Hialeah, FL 33012
Alzheimer's Research and Treatment Center
Lake Worth, FL 33449
Qtrials, Inc.
Miami, FL 33144
Future Care Solutions, LLC
Miami, FL 33165
Miami Dade Medical Research Institute
Miami, FL 33176
Sensible Healthcare LLC
Ocoee, FL 34761
Bioclinica Research
Orlando, FL 32806
Anchor Neuroscience
Pensacola, FL 32502
Suncoast Neuroscience Associates, Inc.
Saint Petersburg, FL 33713
Brain Matters Research at the Kane Center
Stuart, FL 34997
Stedman Clinical Trials
Tampa, FL 33613
Georgia
Columus Memory Center
Columbus, GA 31909
NeuroStudies.net, LLC
Decatur, GA 30033
Idaho
Northwest Clinical Trials
Boise, ID 83704
Illinois
Alexian Brothers Neurosciences Research
Elk Grove Village, IL 60007
Kansas
Ascension Via Christi Research
Wichita, KS 67214
Massachusetts
Activmed Practices and Research
Methuen, MA 01844
The Boston Center for Memory
Newton, MA 02459
Anil Nair MD, Alzheimer's Disease Center
Quincy, MA 02169
Mississippi
Memory Center
Hattiesburg, MS 39401
Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, NV 89106
New Jersey
Princeton Medical Institute
Princeton, NJ 08540
The Cognitive Research Center of New Jersey
Springfield, NJ 07081
Neurology Specialists of Monmouth County
West Long Branch, NJ 07764
New Mexico
Albuquerque Neuroscience
Albuquerque, NM 87109
New York
Disease Research & Neurology Center of Neurological Associates of Albany
Albany, NY 12208
Integrative Clinical Trials LLC
Brooklyn, NY 11229
Spri Clinicaltrials, Llc
Brooklyn, NY 11235
Mid Hudson Medical Research
New Windsor, NY 12553
North Carolina
ANI Neurology, PLLC dba Alzheimer's Memory Center
Charlotte, NC 28270
Ohio
Insight Clinical Trials, LLC
Beachwood, OH 44122
Neurology Diagnostics Inc.
Dayton, OH 45459
Oregon
Memory Health Center at Summit Research Network
Portland, OR 97210
Pennsylvania
Northeastern Pennsylvania Memory and Alzheimer's Center
Plains, PA 18507
Texas
Senior Adults Specialty Research
Austin, TX 78757
Kerwin Research Center
Dallas, TX 75231
Neurology Consultants of Dallas
Dallas, TX 75243
Houston Methodist Department of Neurology
Houston, TX 77030
Clinical Trial Network
Houston, TX 77074
Virginia
University of Virginia Adult Neurology
Charlottesville, VA 22903
Recognition Health
Fairfax, VA 22031
Washington
Northwest Clinical Research Center
Bellevue, WA 98007
UW Alzheimer's Disease Research Center
Seattle, WA 98104
Wisconsin
Medical College of Wisconsin, Inc.
Milwaukee, WI 53226

Who Sponsors This Study?

Lead: Cortexyme Inc.

Source: ClinicalTrials.gov ID: NCT03823404