Skip to main content

GAIN Trial: COR388 for Alzheimer's Disease

Recruiting

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.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 80 Years All No
April 24, 2019
December 31, 2022
573

  • 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

  • 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)

COR388 is a small molecule drug that inhibits gingipains, an enzyme produced by bacteria associated with periodontitis, or inflammation of the gums and supporting structures of the teeth. Periodontitis has been linked to Alzheimer's disease in observational studies, and elevated levels of gingipains have been observed in Alzheimer's brain tissue.

Participants in this study will take either a capsule of the placebo or study drug, in either 40 mg or 80 mg doses, for 48 weeks. Researchers will analyze saliva, blood, and cerebrospinal fluid (if participant undergoes lumbar puncture) for biological signs of Alzheimer's disease and neuroinflammation and for the presence of bacterial DNA associated with periodontal disease. Researchers will also measure changes in cognitive function and ability to complete everyday tasks.

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

Name City State Zip Status Primary Contact
Xenoscience, Inc.
Phoenix Arizona 85004 Recruiting Randi Carr
602-274-9500
Rcarr@xenoscience.com
Banner Alzheimer's Institute
Phoenix Arizona 85006 Recruiting Jenna Leger
602-839-4894
jenna.leger@bannerhealth.com
Banner Sun Health
Sun City Arizona 85351 Recruiting Nadira Trncic
623-832-6590
Nadira.trncic@bannerhealth.com
ATP Clinical Research, Inc.
Costa Mesa California 92626 Recruiting Bobby Shih
714-277-4472
bshih@atpcr.com
Alliance Research
Long Beach California 90807 Terminated

Standford University
Palo Alto California 94305 Recruiting Amanda Ng
650-485-9560
amandang@standford.edu
CITRIALS
Riverside California 92506 Terminated

CITRIALS
Santa Ana California 92705 Recruiting John Ann
714-979-4101
john.ann@citrials.com
Syrentis Clinical Research
Santa Ana California 92705 Active, not recruiting

Southern California Research LLC
Simi Valley California 93065 Active, not recruiting

JEM Research Institute
Atlantis Florida 33462 Recruiting Meslissa Daggerhart, MBA, CCRP
561-968-2933
mdaggerhart@jemri.net
Brain Matters Research
Delray Beach Florida 33445 Recruiting Jetliza Lesmes
561-381-9060
JLESMES@ERGCLINICAL.COM
Neuropsychiatric Research Center of Southwest Florida
Fort Myers Florida 33912 Recruiting Bernardo Avila
239-939-7777
neurocontact@ergclinical.com
MD Clinical
Hallandale Beach Florida 33009 Recruiting Evelyn Quiles
954-455-5757
equiles@mdclinical.org
Indago Research and Health Center, Inc.
Hialeah Florida 33012 Recruiting Violeta Gomez
305-825-6588
vgomez@indagoresearch.org
Alzheimer's Research and Treatment Center
Lake Worth Florida 33449 Recruiting Jennifer Lipofsky
561-209-2400
jlipofsky@researchalz.com
Qtrials, Inc.
Miami Florida 33144 Terminated

Future Care Solutions, LLC
Miami Florida 33165 Active, not recruiting

Miami Dade Medical Research Institute
Miami Florida 33176 Recruiting Ramon Avellana
305-722-7210
ravellana@miamimedresearch.com
Sensible Healthcare LLC
Ocoee Florida 34761 Recruiting Kelly Taylor, MD
407-654-2724
drtaylor@sensiblehealthcare.net
Bioclinica Research
Orlando Florida 32806 Recruiting Matthew Bubalo
407-841-0502
Matthew.Bubalo@bioclinica.com
Anchor Neuroscience
Pensacola Florida 32502 Recruiting Lynn Head-Jolliff, RN, BSN
850-433-6760
lheadjolliff@anchorneuroscience.com
Suncoast Neuroscience Associates, Inc.
Saint Petersburg Florida 33713 Recruiting Chelsea Morris Rizer
727-202-2629
cmorris@suncoastneuroresearch.com
Brain Matters Research at the Kane Center
Stuart Florida 34997 Recruiting Jetliza Lesmes
772-223-7880
info@brainmattersresearch.com
Stedman Clinical Trials
Tampa Florida 33613 Recruiting Shaun Crittenden
813-971-8311
Shaun_crittenden@stedmanclinicaltrials.com
Columus Memory Center
Columbus Georgia 31909 Recruiting Jonathan Liss, MD
706-653-8455
CMC@LissMD.com
NeuroStudies.net, LLC
Decatur Georgia 30033 Recruiting Jenn Cavin
404-475-0552
jcavin@neurostudies.net
Northwest Clinical Trials
Boise Idaho 83704 Recruiting Clarie Harris
208-225-5300
charris@nwct.com
Alexian Brothers Neurosciences Research
Elk Grove Village Illinois 60007 Recruiting Jennifer Coates, MPH
847-593-8553
Jennifer.Coates@amitahealth.org
Ascension Via Christi Research
Wichita Kansas 67214 Recruiting Janie Krull
316-291-4673
Janie.krull@ascension.org
Activmed Practices and Research
Methuen Massachusetts 01844 Active, not recruiting

The Boston Center for Memory
Newton Massachusetts 02459 Recruiting Crystal Tarrago, CRC
617-699-6927
crystal@bostonmemory.com
Anil Nair MD, Alzheimer's Disease Center
Quincy Massachusetts 02169 Active, not recruiting

Memory Center
Hattiesburg Mississippi 39401 Recruiting Kayleigh Russell
601-579-5016
Kayleigh.russell@hattiesburgclinic.com
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas Nevada 89106 Recruiting Yolande Mucharbach
702-685-7070
muchary@ccf.org
Princeton Medical Institute
Princeton New Jersey 08540 Recruiting Claire Pasquale
609-921-6050
cpasquale@gminstitutes.com
The Cognitive Research Center of New Jersey
Springfield New Jersey 07081 Recruiting Kavita Doshi
973-850-4622
kdoshi@thecrcnj.com
Neurology Specialists of Monmouth County
West Long Branch New Jersey 07764 Active, not recruiting

Albuquerque Neuroscience
Albuquerque New Mexico 87109 Recruiting Robert Kushner, MD
505-848-3773
robert@albneuro.com
Disease Research & Neurology Center of Neurological Associates of Albany
Albany New York 12208 Recruiting Richard Holub, MD
518-426-0575
Research@naaresearch.com
Integrative Clinical Trials LLC
Brooklyn New York 11229 Active, not recruiting

Spri Clinicaltrials, Llc
Brooklyn New York 11235 Active, not recruiting

Mid Hudson Medical Research
New Windsor New York 12553 Recruiting Sashi Makam, MD
844-337-8839
crc@mhmresearch.com
ANI Neurology, PLLC dba Alzheimer's Memory Center
Charlotte North Carolina 28270 Recruiting Marissa McRae
704-364-4000
mmcrae@amcneurology.com
Insight Clinical Trials, LLC
Beachwood Ohio 44122 Recruiting Elisa Poggi
216-526-1843
epoggi1@gmail.com
Neurology Diagnostics Inc.
Dayton Ohio 45459 Recruiting Ridwan Ahmad
937-224-8200
ridwan.ahmad@neurologydiagnostics.com
Memory Health Center at Summit Research Network
Portland Oregon 97210 Recruiting Tawnya
503-228-2273
oregon@summitnetwork.com
Northeastern Pennsylvania Memory and Alzheimer's Center
Plains Pennsylvania 18507 Recruiting Luanne Paul
570-262-0664
Senior Adults Specialty Research
Austin Texas 78757 Recruiting Mario Velasquez
512-407-8628
mvelasquez@senioradults.net
Kerwin Research Center
Dallas Texas 75231 Recruiting Jennifer Vo
214-345-4449
Jennifervo@KerwinResearchCenter.com
Neurology Consultants of Dallas
Dallas Texas 75243 Recruiting Research Department
214-750-9977
research@neurologydallas.com
Houston Methodist Department of Neurology
Houston Texas 77030 Recruiting Stephanie Wenzlawsh
713-441-9484
swenzlawsh@houstonmethodist.org
Clinical Trial Network
Houston Texas 77074 Recruiting Contact
281-533-5000
University of Virginia Adult Neurology
Charlottesville Virginia 22903 Recruiting Colleen Webber, CCRC
434-243-5898
cmn6x@virginia.edu
Recognition Health
Fairfax Virginia 22031 Recruiting Study Specialist Team
571-418-0142
marketing@re-cognitionhealth.com
Northwest Clinical Research Center
Bellevue Washington 98007 Recruiting
425-453-0404
study@nwcrc.net
UW Alzheimer's Disease Research Center
Seattle Washington 98104 Recruiting Yeung Tutterow
206-897-6350
ylt2@uw.edu
Medical College of Wisconsin, Inc.
Milwaukee Wisconsin 53226 Recruiting Barb Blaney
414-955-0609

Cortexyme Inc.

Name Phone Email
Michael J. Detke, MD, PhD 415-910-5717 clincaltrials@cortexyme.com

NCT03823404

GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer's Disease