A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease
- Registration Number
- NCT05531656
- Lead Sponsor
- Cognition Therapeutics
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 540
- Ages 50-85 years.
- Diagnosis of either MCI due to AD or mild AD dementia.
- MMSE 20-30 (inclusive).
- Amyloid PET scan of the brain or CSF biomarkers consistent with AD.
- Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease, as based on central read.
-
Screening MRI of the brain indicative of significant abnormality.
-
Clinically significant abnormalities in screening laboratory tests.
-
Clinical or laboratory findings consistent with:
- Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
- Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
- Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12, other laboratory values etc.)
-
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.
-
A current DSM-V diagnosis of active major depression or GDS > 6, schizophrenia, or bipolar disorder.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo, n=180 group CT1812 200 mg CT1812 CT1812 at a dose of 300mg, n=180 group CT1812 100 mg CT1812 CT1812 at a dose of 100 n=180 group
- Primary Outcome Measures
Name Time Method Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale. 18 months The Clinical Dementia Rating (CDR) is a clinical scale that describes 5 levels of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia as absent, questionable, mild, moderate, or severe (global CDR scores of 0, 0.5, 1, 2, or 3, respectively). The score is based on interviews with the participant and study partner, using a structured interview. A sum of boxes score (CDR-SB) provides an additional measure of change where each category has a maximum possible score of 3 points and the total score is a sum of the category scores giving a total possible score of 0 to 18 with higher scores indicating more impairment.
- Secondary Outcome Measures
Name Time Method Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13) 18 months Change from baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13) at 18 months.
Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI. 18 months Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI at 18 months.
Cerebrospinal fluid (CSF) concentrations of beta-amyloid (Aβ) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin. 18 months Change from baseline at 18 months.
Plasma measures of Aβ fragments, ptau, and Neurofilament light (NfL) 18 months Change from baseline at 18 months.
Volumetric Magnetic Resonance Imaging (MRI) including hippocampal and whole brain volume change 18 months Change from baseline at 18 months.
Trial Locations
- Locations (46)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
University of California
🇺🇸Irvine, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Howard University
🇺🇸Washington, District of Columbia, United States
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Mayo Clinic,Jacksonville
🇺🇸Jacksonville, Florida, United States
JEM Research Institute
🇺🇸Lake Worth, Florida, United States
K2 Medical Research, LLC
🇺🇸Maitland, Florida, United States
Advanced Clinical Research Network, Corp
🇺🇸Miami, Florida, United States
Charter Research
🇺🇸Orlando, Florida, United States
Headlands Research Orlando
🇺🇸Orlando, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Conquest Research, LLC
🇺🇸Winter Park, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Sanders-Brown Center on Aging
🇺🇸Lexington, Kentucky, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Highlands Research Eastern MA
🇺🇸Plymouth, Massachusetts, United States
University of Michigan, Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic, Rochester
🇺🇸Rochester, Minnesota, United States
Washington University School of Medicine
🇺🇸St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
🇺🇸Las Vegas, Nevada, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Case Western Reserve University / University Hospitals
🇺🇸Beachwood, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Central States Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Summit Headlands LLC
🇺🇸Portland, Oregon, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Abington Neurological Associates
🇺🇸Abington, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Butler Hospital
🇺🇸Providence, Rhode Island, United States
Ralph H. Johnson VA MC
🇺🇸Charleston, South Carolina, United States
Vanderbilt University Medical Center Center for Cognitive Medicine
🇺🇸Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Houston Methodist Neurological Institute
🇺🇸Houston, Texas, United States
University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States