NCT05531656Active, not recruitingPhase 2
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.
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 540 (estimated)
- First submitted
- 8 Aug 2022
- Start date
- 28 Jun 2023
- Primary completion date
- 31 May 2027
- Lead sponsor
- Cognition Therapeutics
- Diseases
- Alzheimer disease
- NCT number
- NCT05531656
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 540
- From 28 Jun 2023 to the primary completion date, 31 May 2027
- 49 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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.)
Other
- Screening MRI of the brain indicative of significant abnormality.
Who the study is looking for
- 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.
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (49)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Abington Neurological Associates Coordinator of this site? Confirm its status | Abington | United States | Unknown status |
| University of Michigan, Ann Arbor Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| John Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Case Western Reserve University / University Hospitals Coordinator of this site? Confirm its status | Beachwood | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Ralph H. Johnson VA MC Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Brain Matters Research Coordinator of this site? Confirm its status | Delray Beach | United States | Unknown status |
| Neuropsychiatric Research Center of Southwest Florida Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Houston Methodist Neurological Institute Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of California Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| JEM Research Institute Coordinator of this site? Confirm its status | Lake Worth | United States | Unknown status |
| Cleveland Clinic Lou Ruvo Center for Brain Health Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Sanders-Brown Center on Aging Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| K2 Medical Research, LLC Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| Advanced Clinical Research Network, Corp Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Vanderbilt University Medical Center Center for Cognitive Medicine Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Mount Sinai School of Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Headlands Research Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Charter Research Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Banner Alzheimer's Institute Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Highlands Research Eastern MA Coordinator of this site? Confirm its status | Plymouth | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Summit Headlands LLC Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Butler Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Sutter Institute for Medical Research Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| University of Texas Health Science Center Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Brain Matters Research Stuart Coordinator of this site? Confirm its status | Stuart | United States | Unknown status |
| Banner Sun Health Research Institute Coordinator of this site? Confirm its status | Sun City | United States | Unknown status |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Central States Research, LLC Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Howard University Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Georgetown University Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| Conquest Research, LLC Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.