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
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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.
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Screening MRI of the brain indicative of significant abnormality.
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Clinically significant abnormalities in screening laboratory tests.
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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.)
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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.
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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 CT1812 100 mg CT1812 CT1812 at a dose of 100 n=180 group Placebo Placebo Placebo, n=180 group CT1812 200 mg CT1812 CT1812 at a dose of 300mg, 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 synthesize...
- 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 (Aฮฒ) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin. 18 months Change from baseline at 18 months.
Plasma measures of Aฮฒ 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 (40)
Banner Alzheimer's Institute
๐บ๐ธPhoenix, Arizona, United States
Banner Sun Health Research Institute
๐บ๐ธSun City, Arizona, United States
Brain Matters Research
๐บ๐ธDelray Beach, Florida, United States
Charter Research
๐บ๐ธOrlando, Florida, United States
Conquest Research, LLC
๐บ๐ธWinter Park, Florida, United States
Indiana University
๐บ๐ธIndianapolis, Indiana, United States
Case Western Reserve University / University Hospitals
๐บ๐ธBeachwood, Ohio, United States
Summit Headlands LLC
๐บ๐ธPortland, Oregon, United States
University of Texas Southwestern Medical Center
๐บ๐ธDallas, Texas, United States
Houston Methodist Neurological Institute
๐บ๐ธHouston, Texas, United States
University of Alabama at Birmingham
๐บ๐ธBirmingham, Alabama, United States
University of California
๐บ๐ธIrvine, California, United States
Stanford University
๐บ๐ธPalo Alto, California, United States
Yale University
๐บ๐ธNew Haven, Connecticut, United States
Georgetown University
๐บ๐ธWashington, District of Columbia, United States
Howard University
๐บ๐ธWashington, District of Columbia, United States
Mayo Clinic,Jacksonville
๐บ๐ธJacksonville, Florida, United States
JEM Research Institute
๐บ๐ธLake Worth, Florida, United States
K2 Medical Research, LLC
๐บ๐ธMaitland, Florida, United States
University of South Florida
๐บ๐ธTampa, Florida, United States
Rush University Medical Center
๐บ๐ธChicago, Illinois, United States
Sanders-Brown Center on Aging
๐บ๐ธLexington, Kentucky, United States
Brigham and Women's Hospital
๐บ๐ธBoston, Massachusetts, United States
Highlands Research Eastern MA
๐บ๐ธPlymouth, Massachusetts, United States
University of Michigan, Ann Arbor
๐บ๐ธAnn Arbor, Michigan, United States
Mayo Clinic, Rochester
๐บ๐ธRochester, Minnesota, United States
Washington University School of Medicine
๐บ๐ธSaint Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
๐บ๐ธLas Vegas, Nevada, United States
Mount Sinai School of Medicine
๐บ๐ธNew York, New York, United States
University of Rochester Medical Center
๐บ๐ธRochester, New York, United States
Wake Forest University Health Sciences
๐บ๐ธWinston-Salem, North Carolina, United States
Ohio State University
๐บ๐ธColumbus, Ohio, United States
Central States Research, LLC
๐บ๐ธTulsa, Oklahoma, United States
Oregon Health & Science University
๐บ๐ธPortland, Oregon, United States
Abington Neurological Associates
๐บ๐ธAbington, Pennsylvania, United States
University of Pennsylvania
๐บ๐ธPhiladelphia, Pennsylvania, United States
Butler Hospital
๐บ๐ธProvidence, Rhode Island, United States
Ralph H. Johnson VA MC
๐บ๐ธCharleston, South Carolina, United States
Baylor College of Medicine
๐บ๐ธHouston, Texas, United States
University of Wisconsin
๐บ๐ธMadison, Wisconsin, United States