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Purpose

This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease.

Condition

Eligibility

Eligible Ages
Between 50 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Ages 50-85 years. 2. Diagnosis of either MCI due to AD or mild AD dementia. 3. MMSE 20-30 (inclusive). 4. Amyloid PET scan of the brain or CSF biomarkers consistent with AD. 5. Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease, as based on central read.

Exclusion Criteria

  1. Screening MRI of the brain indicative of significant abnormality. 2. Clinically significant abnormalities in screening laboratory tests. 3. Clinical or laboratory findings consistent with: 1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.). 2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.). 3. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12, other laboratory values etc.) 4. A participant known to be actively infected with hepatitis B or hepatitis C at screening. History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C [HCV] antibody). Participants who have evidence of resolved hepatitis infection (e.g., HCV RNA negative) may be considered following discussion with the Medical Monitor. 5. A current DSM-V diagnosis of active major depression or GDS > 6, schizophrenia, or bipolar disorder.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
CT1812 100 mg 		CT1812 at a dose of 100 n=180 group
  • Drug: CT1812
    Study Drug
    Other names:
    • Study Drug Active
Active Comparator
CT1812 200 mg 		CT1812 at a dose of 300mg, n=180 group
  • Drug: CT1812
    Study Drug
    Other names:
    • Study Drug Active
Placebo Comparator
Placebo 		Placebo, n=180 group
  • Drug: Placebo
    Non-active study drug
    Other names:
    • Matching Placebo

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
David Geldmacher

Banner Alzheimer's Institute
Phoenix, Arizona 85006
Contact:
Pallavi Joshi

Banner Sun Health Research Institute
Sun City, Arizona 85351
Contact:
Alireza Atri

University of California
Irvine, California 92697
Contact:
S. Ahmad Sajjadi

Stanford University
Palo Alto, California 94304
Contact:
Sharon Sha

Yale University
New Haven, Connecticut 06510
Contact:
Ryan O'Dell

Georgetown University
Washington, District of Columbia 20057
Contact:
Raymond Scott Turner

Howard University
Washington, District of Columbia 20060
Contact:
Thomas Obisesan

Brain Matters Research
Delray Beach, Florida 33445
Contact:
Paayal Patel

Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida 33912
Contact:
John Huffaker

Mayo Clinic,Jacksonville
Jacksonville, Florida 32216
Contact:
Neill Graff-Radford

JEM Research Institute
Lake Worth, Florida 33462
Contact:
Linda Pao

K2 Medical Research, LLC
Maitland, Florida 32751
Contact:
Sheila Baez-Torres

Advanced Clinical Research Network, Corp
Miami, Florida 33135
Contact:
Gil Fernandez-Yera, MD

Charter Research
Orlando, Florida 32803
Contact:
Diana P Balsalobre

Headlands Research Orlando
Orlando, Florida 32819
Contact:
Theodore Lee, MD

University of South Florida
Tampa, Florida 33613
Contact:
Ram Bishnoi

Conquest Research, LLC
Winter Park, Florida 32789
Contact:
Rekha Gandhi

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Neelum Aggarwal

Indiana University
Indianapolis, Indiana 46202
Contact:
Jared Bosh

Sanders-Brown Center on Aging
Lexington, Kentucky 40504
Contact:
Gregory Jicha, MD, PhD

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Seth Gale

Highlands Research Eastern MA
Plymouth, Massachusetts 02360
Contact:
Donald Marks

University of Michigan, Ann Arbor
Ann Arbor, Michigan 48109
Contact:
Judith Heidebrink

Mayo Clinic, Rochester
Rochester, Minnesota 55901
Contact:
Jonathan Graff-Radford

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Joy Snider

Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada 89106
Contact:
Charles Bernick

Mount Sinai School of Medicine
New York, New York 10029
Contact:
Mary Sano

Columbia University Medical Center
New York, New York 10032
Contact:
Karen Bell, MD

University of Rochester Medical Center
Rochester, New York 14620
Contact:
Anton Porsteinsson

Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Contact:
Suzanne Craft

Case Western Reserve University / University Hospitals
Beachwood, Ohio 44122
Contact:
Charles Duffy

Ohio State University
Columbus, Ohio 43210
Contact:
Douglas Scharre

Central States Research, LLC
Tulsa, Oklahoma 74136
Contact:
Michael Karathanos

Summit Headlands LLC
Portland, Oregon 97210
Contact:
Scott Losk

Oregon Health & Science University
Portland, Oregon 97239
Contact:
Aimee Pierce

Abington Neurological Associates
Abington, Pennsylvania 19001
Contact:
David Weisman

University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Sanjeev Vaishnavi

Butler Hospital
Providence, Rhode Island 02906
Contact:
Meghan Riddle

Ralph H. Johnson VA MC
Charleston, South Carolina 29401
Contact:
Jessica Broadway

Vanderbilt University Medical Center Center for Cognitive Medicine
Nashville, Tennessee 37212
Contact:
Patricia Andrews, MD

University of Texas Southwestern Medical Center
Dallas, Texas 75390
Contact:
Brendan Kelley

Baylor College of Medicine
Houston, Texas 77030
Contact:
Melissa Yu

Houston Methodist Neurological Institute
Houston, Texas 77030
Contact:
Juan Toledo Atucha

University of Texas Health Science Center
San Antonio, Texas 78229
Contact:
Arash Salardini, MD

University of Wisconsin
Madison, Wisconsin 53726
Contact:
Cynthia Carlsson

More Details

NCT ID
NCT05531656
Status
Recruiting
Sponsor
Cognition Therapeutics

Study Contact

Theresa Devins, DrPH, MS
888-745-1050
clinicaltrials@cogrx.com

Detailed Description

This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo for approximately 18 months (72 weeks) in approximately 540 participants diagnosed with early Alzheimer's disease Participants will be randomized 1:1:1 to receive either 100mg or 200mg of CT1812 or placebo. CT1812 or placebo will be administered as 2 capsules to be taken orally once daily.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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