Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies
NCT ID: NCT05225415
Last Updated: 2025-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2022-05-19
2024-11-25
Brief Summary
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Detailed Description
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Patients will be randomized 1:1:1 to placebo, 100mg CT1812 or 300mg CT1812. Oral CT1812 will be taken daily. Subjects meeting eligibility requirement and signing informed consent will be assessed by repeated psychometric/neurologic testing, safety procedures and PK and PD sample collection at defined intervals throughout the study. Plasma and CSF biomarkers will also be followed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CT1812 300 mg
CT1812 300 mg
CT1812
Orally administered CT1812
CT1812 100 mg
CT1812 100 mg
CT1812
Orally administered CT1812
Placebo
Placebo
CT1812
Orally administered CT1812
Interventions
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CT1812
Orally administered CT1812
Eligibility Criteria
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Inclusion Criteria
* MRI, or CT scan due to contraindication of MRI if approved by medical monitor) obtained during screening consistent with the clinical diagnosis of DLB and without findings of significant exclusionary abnormalities. An historical MRI (or CT scan), up to 1 year prior to screening, may be used if there is no history of intervening neurologic disease or clinical events (such as a stroke, head trauma etc.) and the subject is without clinical symptoms or signs suggestive of such intervening events.
* MMSE 18-27 inclusive
Exclusion Criteria
* Screening MRI (or historical MRI or CT scan due to contraindication of MRI if approved by medical monitor) or historical MRI/CT scan, if applicable. of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct \> 1 cm3, \>3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma). If a small incidental meningioma is observed, the medical monitor may be contacted to discuss eligibility.
* Clinical, laboratory findings or medical history consistent with:
1. Other primary degenerative dementia (fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
2. Other neurodegenerative condition (amyotrophic lateral sclerosis, etc.).
3. Seizure disorder.
4. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).
* Any major psychiatric diagnosis, including schizophrenia, bipolar disorder, and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition
* Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.
50 Years
85 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Cognition Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Anthony Caggiano, MD
Role: STUDY_DIRECTOR
Cognition Therapeutics Inc.
Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
University of Arizona - Health Sciences Center
Tucson, Arizona, United States
Stanford University
Palo Alto, California, United States
Pacific Neuroscience Institute
Santa Monica, California, United States
University of Colorado
Aurora, Colorado, United States
CenExel Rocky Mountain Clinical Research, LLC
Englewood, Colorado, United States
New England Institute for Neurology and Headache (NEINH)
Stamford, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
University of Miami Miller School of Medicine Comprehensive Center for Brain Health
Boca Raton, Florida, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Charter Research
Lady Lake, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Charter Research
Winter Park, Florida, United States
Rush University Medical Center Section of Parkinson Disease and Movement Disorder
Chicago, Illinois, United States
IU Health Neuroscience Center, Goodman Hall
Indianapolis, Indiana, United States
Josephson Wallack Munshower Neurology, P.C
Indianapolis, Indiana, United States
The University of Kansas Alzheimer's Disease Research Center
Fairway, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Headlands Research Eastern Massachusetts, LLC
Plymouth, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Columbia University
New York, New York, United States
UNC Department of Neurology
Chapel Hill, North Carolina, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Summit Headlands, LLC
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas Southwestern
Dallas, Texas, United States
Clinical Trial Network
Houston, Texas, United States
University of Virginia Adult Neurology
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Evergreen Health Research
Kirkland, Washington, United States
Universtiy of Washington Department of Neurology
Seattle, Washington, United States
Countries
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Related Links
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Title: "Together we can light the way for Dementia with Lewy Bodies research."
Other Identifiers
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COG1201
Identifier Type: -
Identifier Source: org_study_id
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