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

NCT03823404 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: COR388-010
• Study Type: interventional
• Target: 643
• Locations: 6 countries
• Sites: 93

Brief Summary

This is a randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease (AD) dementia.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)

  Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) - Total Score The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. he scale ranges from 0 to 70, with higher scores indicating greater disease severity.

  Baseline to Week 48

• Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)

  The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory. The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.

  Baseline to Week 48

Secondary Outcomes (3)

• Clinical Dementia Rating-Sum of Boxes (CDR-SB)

  Baseline to Week 48

• Mini-Mental State Examination (MMSE)

  Baseline to Week 48

• Neuropsychiatric Inventory (NPI)

  Baseline to Week 48

Other Outcomes (3)

• Anti-P. Gingivalis IgG in Serum

  Baseline to Week 48

• Magnetic Resonance Imaging

  Baseline to Week 48

• Periodontal (or Gum) Pocket Depth

  Baseline to Week 48

Study Arms (3)

COR388 80 mg twice daily (BID)

EXPERIMENTAL

COR388 hydrochloric acid (HCl), 80 mg orally administered capsule, BID (twice daily) with water approximately 12 hours apart and no less than 6 hours apart

Drug: COR388 capsule

COR388 40 mg BID

EXPERIMENTAL

COR388 HCl, 40 mg orally administered capsule, BID with water approximately 12 hours apart and no less than 6 hours apart

Drug: COR388 capsule

Placebo BID

PLACEBO COMPARATOR

Placebo orally administered capsule, BID with water approximately 12 hours apart and no less than 6 hours apart

Drug: Placebo capsule

Interventions

COR388 capsule DRUG

BID (twice daily)

Also known as: atuzaginstat

COR388 40 mg BID; COR388 80 mg twice daily (BID)

Placebo capsule DRUG

BID

Also known as: atuzaginstat

Placebo BID

Eligibility Criteria

• Age: 55 Years - 80 Years
• Gender Eligibility Details: Male and female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has probable AD dementia according to the NIA-AA criteria.
• Subject has an Mini-Mental State Examination (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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Cortexyme Inc.: lead

Study Sites (93)

Xenoscience, Inc.

Phoenix, Arizona, 85004, United States

Location

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Banner Sun Health

Sun City, Arizona, 85351, United States

Location

ATP Clinical Research, Inc.

Costa Mesa, California, 92626, United States

Location

Alliance Research

Long Beach, California, 90807, United States

Location

Standford University

Palo Alto, California, 94305, United States

Location

CITRIALS

Riverside, California, 92506, United States

Location

CITRIALS

Santa Ana, California, 92705, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Southern California Research LLC

Simi Valley, California, 93065, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, 33912, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Indago Research and Health Center, Inc.

Hialeah, Florida, 33012, United States

Location

Alzheimer's Research and Treatment Center

Lake Worth, Florida, 33449, United States

Location

Qtrials, Inc.

Miami, Florida, 33144, United States

Location

Future Care Solutions, LLC

Miami, Florida, 33165, United States

Location

Miami Dade Medical Research Institute

Miami, Florida, 33176, United States

Location

Sensible Healthcare LLC

Ocoee, Florida, 34761, United States

Location

Bioclinica Research

Orlando, Florida, 32806, United States

Location

Anchor Neuroscience

Pensacola, Florida, 32502, United States

Location

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, 33713, United States

Location

Brain Matters Research at the Kane Center

Stuart, Florida, 34997, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Columus Memory Center

Columbus, Georgia, 31909, United States

Location

NeuroStudies.net, LLC

Decatur, Georgia, 30033, United States

Location

Northwest Clinical Trials

Boise, Idaho, 83704, United States

Location

Alexian Brothers Neurosciences Research

Elk Grove Village, Illinois, 60007, United States

Location

Ascension Via Christi Research

Wichita, Kansas, 67214, United States

Location

Activmed Practices and Research

Methuen, Massachusetts, 01844, United States

Location

The Boston Center for Memory

Newton, Massachusetts, 02459, United States

Location

Anil Nair MD, Alzheimer's Disease Center

Quincy, Massachusetts, 02169, United States

Location

Memory Center

Hattiesburg, Mississippi, 39401, United States

Location

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, 89106, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

The Cognitive Research Center of New Jersey

Springfield, New Jersey, 07081, United States

Location

Neurology Specialists of Monmouth County

West Long Branch, New Jersey, 07764, United States

Location

Albuquerque Neuroscience

Albuquerque, New Mexico, 87109, United States

Location

Disease Research & Neurology Center of Neurological Associates of Albany

Albany, New York, 12208, United States

Location

Integrative Clinical Trials LLC

Brooklyn, New York, 11229, United States

Location

Spri Clinicaltrials, Llc

Brooklyn, New York, 11235, United States

Location

Mid Hudson Medical Research

New Windsor, New York, 12553, United States

Location

ANI Neurology, PLLC dba Alzheimer's Memory Center

Charlotte, North Carolina, 28270, United States

Location

Insight Clinical Trials, LLC

Beachwood, Ohio, 44122, United States

Location

Neurology Diagnostics Inc.

Dayton, Ohio, 45459, United States

Location

Memory Health Center at Summit Research Network

Portland, Oregon, 97210, United States

Location

Northeastern Pennsylvania Memory and Alzheimer's Center

Plains, Pennsylvania, 18507, United States

Location

Senior Adults Specialty Research

Austin, Texas, 78757, United States

Location

Kerwin Research Center

Dallas, Texas, 75231, United States

Location

Neurology Consultants of Dallas

Dallas, Texas, 75243, United States

Location

Houston Methodist Department of Neurology

Houston, Texas, 77030, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

University of Virginia Adult Neurology

Charlottesville, Virginia, 22903, United States

Location

Recognition Health

Fairfax, Virginia, 22031, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

UW Alzheimer's Disease Research Center

Seattle, Washington, 98104, United States

Location

Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, 53226, United States

Location

Hôpital de Brabois

Toulouse, Cedex, 31059, France

Location

Centre de Ressources Biologiques

Lille, 59037, France

Location

University Hospital La Timone, Department of Neurology and Neuropsychology

Marseille, 13385, France

Location

Service de Gériatrie

Nice, 6100, France

Location

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

Strasbourg, 67098, France

Location

CHRU de Nancy Hôpital de Brabois Service de Gériatrie

Vandœuvre-lès-Nancy, 54500, France

Location

Brain Research Center Den Bosch B.V.

's-Hertogenbosch, 5223 LA, Netherlands

Location

Brain Research Center

Amsterdam, 1081 GN, Netherlands

Location

PreCare Trial & Recruitment

Beek, 6191 JW, Netherlands

Location

Isala Zwolle - Interne geneeskunde Centrum voor ouderengeneeskunde

Zwolle, 8025 AB, Netherlands

Location

Brain Research Center Zwolle

Zwolle, 8025 AZ, Netherlands

Location

Indywidualna Specjalistyczna Praktyka Lekarska

Gdansk, 80-438, Poland

Location

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

Katowice, 40-123, Poland

Location

Krakowska Akademia Neurologii

Krakow, 31-505, Poland

Location

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

Siemianowice Śląskie, 41-100, Poland

Location

Euromedis Sp. z o.o.

Szczecin, 70-111, Poland

Location

Centrum Medyczne NeuroProtect

Warsaw, 01-684, Poland

Location

NZOZ Wrocławskie Centrum Alzheimerowskie

Wroclaw, 53-659, Poland

Location

Policlinica Gipuzkoa

San Sebastián, Gipuzkoa, 20014, Spain

Location

Hospital General de Alicante

Alicante, 03010, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 8005, Spain

Location

Fundacio Ace

Barcelona, 8028, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 8036, Spain

Location

Hospital Universitario Ramón Y Cajal

Madrid, 28034, Spain

Location

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, 8195, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Cognition Health Birmingham (private)

Edgbaston, Birmingham, B16 8LT, United Kingdom

Location

St Pancras Clinical Research (private)

Barbican, London, EC2Y 8EA, United Kingdom

Location

Cognition Health Plymouth

Plymouth, Science Park, PL5 8BT, United Kingdom

Location

Memory Assessment and Research Centre, Moorgreen Hospital

Southampton, UK, SO30 3JB, United Kingdom

Location

RICE - The Research Institute for the Care of Older People

Bath, BA1 3NG, United Kingdom

Location

Glasgow Memory Clinic

Glasgow, G20 0XA, United Kingdom

Location

Cognition Health Ltd. (private) Guildford

Guildford, GU2 7YD, United Kingdom

Location

Cognition Health Ltd. (private) London

London, W1G 9JF, United Kingdom

Location

Kingshill Research Centre Swindon

Swindon, SN3 6BW, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

COR388

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Karen Smith
• Organization: Quince Therapeutics, Inc.

ksmith@quincetx.com

650 722 9813

Study Officials

• Karen Smith, MD

  Quince Therapeutics Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 30, 2019
• Study Start: March 28, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: February 23, 2023
• Results First Posted: February 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (7); GB (9); ES (8); US (58); FR (6); NL (5)