A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease
Synaptic Therapy Alzheimer's Research Trial (START): A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease Over 18 Months.
2 other identifiers
interventional
540
1 country
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2023
Typical duration for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2022
CompletedFirst Posted
Study publicly available on registry
September 8, 2022
CompletedStudy Start
First participant enrolled
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
September 22, 2025
July 1, 2025
3.8 years
August 8, 2022
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale.
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.
18 months
Secondary Outcomes (5)
Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)
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
Cerebrospinal fluid (CSF) concentrations of beta-amyloid (Aβ) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin.
18 months
Plasma measures of Aβ fragments, ptau, and Neurofilament light (NfL)
18 months
Volumetric Magnetic Resonance Imaging (MRI) including hippocampal and whole brain volume change
18 months
Study Arms (3)
CT1812 100 mg
ACTIVE COMPARATORCT1812 at a dose of 100 n=180 group
CT1812 200 mg
ACTIVE COMPARATORCT1812 at a dose of 300mg, n=180 group
Placebo
PLACEBO COMPARATORPlacebo, n=180 group
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cognition Therapeuticslead
- National Institute on Aging (NIA)collaborator
- Alzheimer's Clinical Trials Consortiumcollaborator
Study Sites (50)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
University of California
Irvine, California, 92697, United States
Stanford University
Palo Alto, California, 94304, United States
Sutter Institute for Medical Research
Sacramento, California, 95816, United States
Yale University
New Haven, Connecticut, 06510, United States
Georgetown University
Washington D.C., District of Columbia, 20057, United States
Howard University
Washington D.C., District of Columbia, 20060, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Mayo Clinic,Jacksonville
Jacksonville, Florida, 32216, United States
JEM Research Institute
Lake Worth, Florida, 33462, United States
K2 Medical Research, LLC
Maitland, Florida, 32751, United States
Advanced Clinical Research Network, Corp
Miami, Florida, 33135, United States
Charter Research
Orlando, Florida, 32803, United States
Headlands Research Orlando
Orlando, Florida, 32819, United States
Brain Matters Research Stuart
Stuart, Florida, 34997, United States
University of South Florida
Tampa, Florida, 33613, United States
Conquest Research, LLC
Winter Park, Florida, 32789, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Sanders-Brown Center on Aging
Lexington, Kentucky, 40504, United States
John Hopkins University
Baltimore, Maryland, 21224, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Highlands Research Eastern MA
Plymouth, Massachusetts, 02360, United States
University of Michigan, Ann Arbor
Ann Arbor, Michigan, 48109, United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55901, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14620, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Case Western Reserve University / University Hospitals
Beachwood, Ohio, 44122, United States
Ohio State University
Columbus, Ohio, 43210, United States
Central States Research, LLC
Tulsa, Oklahoma, 74136, United States
Summit Headlands LLC
Portland, Oregon, 97210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Abington Neurological Associates
Abington, Pennsylvania, 19001, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Ralph H. Johnson VA MC
Charleston, South Carolina, 29401, United States
Vanderbilt University Medical Center Center for Cognitive Medicine
Nashville, Tennessee, 37212, United States
Vanderbilt University Medical Center Center for Cognitive Medicine
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Houston Methodist Neurological Institute
Houston, Texas, 77030, United States
University of Texas Health Science Center
San Antonio, Texas, 78229, United States
University of Wisconsin
Madison, Wisconsin, 53726, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anthony Caggiano, MD
Cognition Therapeutics
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
August 8, 2022
First Posted
September 8, 2022
Study Start
June 28, 2023
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
September 22, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share