CLINICAL TRIALS

GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease

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

Status
Recruiting

Start date
03/28/2019

Healthy
No

Contact

Michael J Detke, MD, PhD

415-910-5717

clinicaltrials@cortexyme.com

Conditions
Alzheimer Disease

Age
55 Years — 80 Years

Gender
All

Summary
This is a randomized, double-blind, placebo-controlled study that will assess the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate AD dementia.

Overview
This is a randomized, double-blind, placebo-controlled study that will assess the efficacy, safety, and tolerability of 2 dose levels of COR388 oral capsules in subjects with probable AD dementia according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. The study will enroll approximately 573 generally healthy male and female subjects ≥55 and ≤80 years of age. Enrolled subjects must have a documented diagnosis of mild to moderate AD dementia. The subject should not have other conditions or brain imaging abnormalities that can explain the symptoms of dementia. All subjects will be encouraged to have LPs (during screening, week 24 and week 48) in the absence of medical conditions that can increase the risk of the procedure in the opinion of the Investigator. Cerebrospinal fluid (CSF), saliva, and blood will be analyzed for measurements of biomarkers of AD and neuroinflammation, and for the presence of bacterial deoxyribonucleic acid (DNA) of Porphyromonas gingivalis (P. gingivalis [Pg]). A subset of sites will monitor subjects for clinical evidence of periodontitis at baseline, 24 and 48 weeks.

The study will consist of 3 periods: a screening period of up to 6 weeks, a treatment period of up to 48 weeks, and a safety follow-up period of 6 weeks.

Eligibility Criteria
Key Inclusion Criteria:

Subject has probable AD dementia according to the NIA-AA criteria.
Subject has an MMSE score 12 and 24 inclusive at both screening and Visit 2 and a ≤3-point difference between these visits.
Subject has brain MRI scan consistent with the diagnosis of AD performed during the screening period. Computed Tomography scan can be used only if the subject has an absolute contraindication for MRI.
Subject has a Modified Hachinski score ≤4 at screening.
Subjects with background symptomatic therapy with acetylcholine esterase inhibitors, and/or memantine, are allowed as long as the dose has been stable for 90 days prior to screening and no changes are planned during the study.
Subject has a primary caregiver willing to accept responsibility for supervising the treatment (e.g., administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.
Subject has body mass index <38 kg/m2 at Screening

Key Exclusion Criteria:

Subject has imaging consistent with a dementia diagnosis other than AD.
Subject has had an increase or restoration of cognition based on medical history.
Subject with history or current evidence of major psychiatric illness such as schizophrenia, bipolar disorder, or major depressive disorder that may interfere with the patient's ability to perform the study and all assessments. NOTE: Mild depression or depressive mood arising in the context of AD are not criteria for exclusion. The use of anti-depressants or the use of anti epileptic medication for non seizure-related treatment is allowed if the dose has remained stable for at least 60 days prior to enrollment.

Subject has any of the following laboratory findings at screening:

Alanine aminotransferase >3 x upper limit of normal (ULN), aspartate aminotransferase >3 x ULN, or history of clinically significant liver disease in the Investigator's judgment.
Hemoglobin ≤10 g/dl.
Creatinine clearance (CL) of <45 ml/min.
Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) >8.
Positive blood screen for Human Immunodeficiency Virus (HIV 1 and 2), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus antibodies (HCV-Ab) at Screening.

Activmed Practices and Research

Methuen, Massachusetts 01844 Active, not recruiting

Albuquerque Neuroscience

Albuquerque, New Mexico 87109 Recruiting

Robert Kushner, MD

505-848-3773

robert@albneuro.com

Geraldine Dempsey, BSN, CCRC

505-848-3773

gerrie@albneuro.com

Glen Michael Dempsey, MD

Alexian Brothers Neurosciences Research

Elk Grove Village, Illinois 60007 Recruiting

Jennifer Coates, MPH

847-593-8553

jennifer.coates@amitahealth.org

Concetta Forchetti, MD

Alliance Research

Long Beach, California 90807 Terminated

Alzheimer's Research and Treatment Center

Lake Worth, Florida 33449 Recruiting

Jennifer Lipofsky

561-209-2400

jlipofsky@researchalz.com

David Watson, MD

Anchor Neuroscience

Pensacola, Florida 32502 Recruiting

Lynn Head-Jolliff, RN, BSN

850-433-6760

lheadjolliff@anchorneuroscience.com

Kevin Groom, MD

ANI Neurology, PLLC dba Alzheimer's Memory Center

Charlotte, North Carolina 28270 Recruiting

Marissa McRae

704-364-4000

mmcrae@amcneurology.com

Mohammad Boulori, MD

Anil Nair MD, Alzheimer's Disease Center

Quincy, Massachusetts 02169 Active, not recruiting

Ascension Via Christi Research

Wichita, Kansas 67214 Recruiting

Janie Krull

316-291-4673

janie.krull@ascension.org

Lisa Aragon

316-291-4673

lisa.aragon@ascension.org

Paul Murphy, MD

ATP Clinical Research, Inc.

Costa Mesa, California 92626 Recruiting

Banner Alzheimer's Institute

Phoenix, Arizona 85006 Recruiting

Jenna Leger

602-839-4894

jenna.leger@bannerhealth.com

Po-Heng Tsai, MD

Banner Sun Health

Sun City, Arizona 85351 Recruiting

Nadira Trncic

623-832-6590

nadira.trncic@bannerhealth.com

Bryan Spann, MD

Bioclinica Research

Orlando, Florida 32806 Recruiting

Matthew Bubalo

407-841-0502

matthew.bubalo@bioclinica.com

Ira Goodman, MD

Brain Matters Research

Delray Beach, Florida 33445 Recruiting

Jetliza Lesmes

561-381-9060

jlesmes@brainmattersresearch.com

Mark Brody, MD

Brain Matters Research at the Kane Center

Stuart, Florida 34997 Recruiting

Jetliza Lesmes

561-381-9060

jlesmes@brainmattersresearch.com

Mark Brody, MD

Brain Research Center

Amsterdam, 1081 GN Recruiting

Brain Research Center Den Bosch B.V.

Den Bosch, 5223 LA Recruiting

Thomas Dautzenberg

+ 31 (0)73 200 4111

t.dautzenberg@brainresearchcenter.nl

Paul Dautzenberg, MD

Brain Research Center Zwolle

Zwolle, 8025 AZ Recruiting

Ad Kamper, MD

Centre de Ressources Biologiques

Lille, 59037 Recruiting

Jean-Louis Vincent

+03 20 44 60 21

jean-louis.vincent@chru-lille.fr

Prof Florence Pasquier, MD

Centrum Medyczne NeuroProtect

Warszawa, 01-684 Recruiting

Marta Biel

+48 22 468 15 48

marta.biel@neuroprotect.pl

Maciej Czarnecki, MD

Centrum Medyczne Plejady

Kraków, 30-363 Withdrawn

CHRU de Nancy Hôpital de Brabois Service de Gériatrie

Vandoeuvre les Nancy, 54500 Recruiting

Georges Valérie

+03 83 15 52 58

v.georges@chru-nancy.fr

Anathase Benetos, MD

CITrials

Santa Ana, California 92705 Recruiting

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada 89106 Recruiting

Clinical Trial Network

Houston, Texas 77074 Recruiting

Contact

281-533-5000

Djamchild Lotfi

Cognition Health Birmingham (private)

Edgbaston, Birmingham B16 8LT Recruiting

Karen Faulkner, MD

441216550174

gziff@re-cognitionhealth.com

Karen Faulkner, MD

Cognition Health Ltd. (private) Guildford

Guildford, GU2 7YD Recruiting

Ahmad Ebadi

+441483388020

aebadi@re-cognitionhealth.com

Emer MacSweeney, MD

Cognition Health Ltd. (private) London

London, W1G 9JF Recruiting

Emer MacSweeney, MD

+442033553536

Emer MacSweeney, MD

Cognition Health Plymouth

Plymouth, Science Park PL5 8BT Recruiting

Hannah Smith

+(01752) 875604

hsmith@re-cognitionhealth.com

Stephen Pearson, MD

Columus Memory Center

Columbus, Georgia 31909 Recruiting

Jonathan Liss, MD

706-653-8455

cmc@lissmd.com

Jonathan Liss, MD

Disease Research & Neurology Center of Neurological Associates of Albany

Albany, New York 12208 Recruiting

Richard Holub, MD

518-426-0575

research@naaresearch.com

Richard Holub, MD

Euromedis Sp. z o.o.

Szczecin, 70-111 Recruiting

Jakub Burdanowski

+48 91 813 63 22

jakub.burdanowski@euromedis.pl

Marcin Ratajczak, MD

Fundacio Ace

Barcelona, 8028 Recruiting

Merce Boada, MD

+34 934304720

Merce Boada, MD

Future Care Solutions, LLC

Miami, Florida 33165 Active, not recruiting

Glasgow Memory Clinic

Glasgow, G20 0XA Recruiting

Hôpital de Brabois

Toulouse, Cedex 31059 Recruiting

Isabelle Carrie

+05 61 77 79 73

carrie.i@chu-toulouse.fr

Emmanuelle HULLIGER SAURT

+05 61 77 79 73

hulliger-saurt.e@chu-toulouse.fr

Pierre Jean Ousset, MD

Hôpitaux Universitaires de Strasbourg, Centre d'Investigation Clinique, Hôpital Hautepierre

Strasbourg, 67098 Recruiting

Thouma-La CHANTHAVINOUT

+33 (0) 3 88 12 84 23

thouma-la.chanthavinout@chru-strasbourg.fr

Frederic Blanc, MD

Hospital Clinic de Barcelona

Barcelona, 08036 Recruiting

Hospital de la Santa Creu i Sant Pau

Barcelona, 8005 Recruiting

Rafael Blesa Gonzalez, MD

+34618846138

Rafael Blesa Gonzalez, MD

Hospital General de Alicante

Alicante, 03010 Recruiting

Rosa Mª Sánchez Pérez, MD

+34 639 748 878

Rosa Mª Sánchez Pérez, MD

+34 665 478 784

Rosa Mª Sánchez Pérez, MD

Hospital Universitari General de Catalunya

Sant Cugat Del Vallès, 8195 Recruiting

Ernest Balaguer Martinez, MD

+34 937 151 575

Ernest Balaguer Martinez, MD

Hospital Universitario Marqués de Valdecilla

Santander, 39008 Recruiting

Pascual Sanchez Juan, MD

+34942204084

Pascual Sanchez Juan, MD

Hospital Universitario Ramón Y Cajal

Madrid, 28034 Recruiting

Guillermo Garcia Ribas, MD

+34629385547

Guillermo Garcia Ribas, MD

Houston Methodist Department of Neurology

Houston, Texas 77030 Recruiting

Stephanie Wenzlawsh

713-441-9484

swenzlawsh@houstonmethodist.org

Joseph Masdeu, MD

Indago Research and Health Center, Inc.

Hialeah, Florida 33012 Recruiting

Indywidualna Specjalistyczna Praktyka Lekarska

Gdańsk, 80-438 Recruiting

Adam Włodarczyk

+48 503 642 588

aswlodarczyk@gmail.com

Wiesław Jerzy Cubala, MD

Insight Clinical Trials, LLC

Beachwood, Ohio 44122 Recruiting

Elisa Poggi

216-526-1843

epoggi1@gmail.com

Mark Stillman, MD

Integrative Clinical Trials LLC

Brooklyn, New York 11229 Active, not recruiting

Isala Zwolle - Interne geneeskunde Centrum voor ouderengeneeskunde

Zwolle, 8025 AB Not yet recruiting

Lonneke Buitenhuis

+31 38 424 8221

l.buitenhuis@isala.nl

Ad Kamper, MD

JEM Research Institute

Atlantis, Florida 33462 Recruiting

Meslissa Daggerhart, MBA, CCRP

561-968-2933

mdaggerhart@jemri.net

Mark Goldstein, MD

Kerwin Research Center

Dallas, Texas 75231 Recruiting

Jennifer Vo

214-345-4449

jennifervo@kerwinresearchcenter.com

Diana Kerwin, MD

Kingshill Research Centre Swindon

Swindon, SN3 6BW Recruiting

Carol Hall

01793327954

carol.hall11@nhs.net

Sabarigirivasan Muthukrishnan, MD

Krakowska Akademia Neurologii

Kraków, 31-505 Recruiting

Marta Pinkosz

+48 663 506 020

marta.pinkosz@neurologia.org.pl

Andrzej Szczudlik, MD

MD Clinical

Hallandale Beach, Florida 33009 Recruiting

Evelyn Quiles

954-455-5757

equiles@mdclinical.org

Beth Safirstein, MD

Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin 53226 Recruiting

Barb Blaney

414-955-0609

Malgorzata Franczak, MD

Memory Assessment and Research Centre, Moorgreen Hospital

Southampton, UK SO30 3JB Recruiting

Clive Holmes, MD

Memory Center

Hattiesburg, Mississippi 39401 Recruiting

Kayleigh Russell

601-579-5016

kayleigh.russell@hattiesburgclinic.com

Richard Schwartz, MD

Memory Health Center at Summit Research Network

Portland, Oregon 97210 Recruiting

Tawnya

503-228-2273

oregon@summitnetwork.com

Scott Losk, MD

Miami Dade Medical Research Institute

Miami, Florida 33176 Recruiting

Ramon Avellana

305-722-7210

ravellana@miamimedresearch.com

Mabel Cruz

mcruz@miamimedresearch.com

Orlando Puente, MD

Mid Hudson Medical Research

New Windsor, New York 12553 Recruiting

Sashi Makam, MD

844-337-8839

crc@mhmresearch.com

Sashi Makam, MD

NEURO-CARE Sp. z o.o. Sp. Komandytowa

Siemianowice Śląskie, 41-100 Recruiting

Weronika Czarnik

+0048 539 333 444

w.czarnik@neuro-care.pl

Gabriela Klodowska, MD

Neurology Consultants of Dallas

Dallas, Texas 75243 Recruiting

Research Department

214-750-9977

research@neurologydallas.com

Duc Tran, MD

Neurology Diagnostics, Inc.

Dayton, Ohio 45459 Recruiting

Ridwan Ahmad

937-224-8200

ridwan.ahmad@neurologydiagnostics.com

Joel Vandersluis, MD

Neurology Specialists of Monmouth County

West Long Branch, New Jersey 07764 Active, not recruiting

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida 33912 Recruiting

Bernardo Avila

239-939-7777

neurocontact@ergclinical.com

Wendy Bond, MD

NeuroStudies.net, LLC

Decatur, Georgia 30033 Recruiting

Jenn Cavin

404-475-0552

jcavin@neurostudies.net

Marshall Nash, MD

Northeastern Pennsylvania Memory and Alzheimer's Center

Plains, Pennsylvania 18507 Recruiting

Luanne Paul

570-262-0664

Mario Cornacchione, MD

Northwest Clinical Research Center

Bellevue, Washington 98007 Recruiting

Northwest Clinical Trials

Boise, Idaho 83704 Recruiting

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

Katowice, 40-123 Recruiting

Anna Blaszta

+48 602 643 900

annablaszta@vp.pl

Lech Szczechowski, MD

NZOZ Wrocławskie Centrum Alzheimerowskie

Wrocław, 53-659 Recruiting

Katarzyna Łuszczek

+48 691288132

katarina.sc@alzheimer.wroclaw.pl

Marzena Zboch, MD

Policlinica Gipuzkoa

San Sebastián, Gipuzkoa 20014 Recruiting

Gurutz Linazasoro, MD

+34943002818

Gurutz Linazasoro, MD

PreCare Trial & Recruitment

Beek, 6191 JW Recruiting

Vivienne van de Walle, MD

+31 (0)46 475 8687

info@ptr.nu

Vivienne van de Walle, MD

Princeton Medical Institute

Princeton, New Jersey 08540 Recruiting

Qtrials, Inc.

Miami, Florida 33144 Terminated

ReCognition Health

London, W1G 9JF Recruiting

Study Specialist Team

571-418-0142

marketing@re-cognitionhealth.com

Raymond Turner, MD

RICE - The Research Institute for the Care of Older People

Bath, Recruiting

Marianne Roots

44 (0)1225 476420

mr699@bath.ac.uk

Roy Jones, MD

Senior Adults Specialty Research

Austin, Texas 78757 Recruiting

Mario Velasquez

512-407-8628

mvelasquez@senioradults.net

Jaron Winston, MD

Sensible Healthcare LLC

Ocoee, Florida 34761 Recruiting

Kelly Taylor, MD

407-654-2724

drtaylor@sensiblehealthcare.net

Kelly Taylor, MD

Service de Gériatrie

Nice, 6100 Recruiting

Justine Lemaire

04 92 03 47 78

lemaire.j@chu-ice.fr

Renaud David, MD

Southern California Research LLC

Simi Valley, California 93065 Active, not recruiting

Spri Clinicaltrials, Llc

Brooklyn, New York 11235 Active, not recruiting

St Pancras Clinical Research (private)

Barbican, London EC2Y 8EA Recruiting

Cristina Perez

+0203 8651142

cristinaperez@stpancrasclinical.com

John Ndikum, MD

Standford University

Palo Alto, California 94305 Recruiting

Amanda Ng

650-485-9560

amandang@standford.edu

Sharron Sha, MD

Stedman Clinical Trials

Tampa, Florida 33613 Recruiting

Shaun Crittenden

813-971-8311

shaun_crittenden@stedmanclinicaltrials.com

Mary Stedman, MD

Suncoast Neuroscience Associates, Inc.

Saint Petersburg, Florida 33713 Recruiting

Chelsea Morris Rizer

727-202-2629

cmorris@suncoastneuroresearch.com

Alberto Vasquez, MD

Syrentis Clinical Research

Santa Ana, California 92705 Active, not recruiting

The Boston Center for Memory

Newton, Massachusetts 02459 Recruiting

Crystal Tarrago, CRC

617-699-6927

crystal@bostonmemory.com

Paul Solomon, MD

The Cognitive Research Center of New Jersey

Springfield, New Jersey 07081 Recruiting

Kavita Doshi

973-850-4622

kdoshi@thecrcnj.com

Chelsea Nigro

973-850-4622

cnigro@thecrcnj.com

Michelle Papka, MD

University Hospital La Timone, Department of Neurology and Neuropsychology

Marseille Cedex 5, 13385 Recruiting

Julie Pelat

+33 491385928

julie.pelat@ap-hm.fr

Mathieu Ceccaldi, MD

University of Virginia Adult Neurology

Charlottesville, Virginia 22903 Recruiting

Colleen Webber, CCRC

434-243-5898

cmn6x@virginia.edu

Carol Manning, MD

UW Alzheimer's Disease Research Center

Seattle, Washington 98104 Recruiting

Yeung Tutterrow

206-897-6350

ylt2@uw.edu

Charles Bernick, MD

Xenoscience, Inc.

Phoenix, Arizona 85004 Recruiting

Randi Carr

602-274-9500

rcarr@xenoscience.com

Stephen Flitman, MD

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