Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies

Last updated: June 12, 2025
Sponsor: Cognition Therapeutics
Overall Status: Completed

Phase

2

Condition

Lewy Body Dementia

Parkinson's Disease

Parkinson's With Dementia

Treatment

CT1812

Clinical Study ID

NCT05225415
COG1201
R01AG071643
R01AG058660
  • Ages 50-85
  • All Genders

Study Summary

Multi-center, randomized, double-blind, placebo-controlled, 6- month study in subjects with mild to moderate Dementia with Lewy Bodies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men or women 50-85 years of age (inclusive), meeting criteria for probable Dementiawith Lewy Bodies (DLB).

  • 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 withoutfindings 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 interveningneurologic disease or clinical events (such as a stroke, head trauma etc.) and thesubject is without clinical symptoms or signs suggestive of such intervening events.

  • MMSE 18-27 inclusive

Exclusion

Exclusion Criteria:

  • Any neurological condition that may be contributing to cognitive impairment aboveand beyond those caused by the subject's DLB, including any co-morbidities detectedby clinical assessment or MRI (or CT scan due to contraindication of MRI, ifapproved by medical monitor)

  • Screening MRI (or historical MRI or CT scan due to contraindication of MRI ifapproved by medical monitor) or historical MRI/CT scan, if applicable. of the brainindicative of significant abnormality, including, but not limited to, priorhemorrhage 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 smallincidental meningioma is observed, the medical monitor may be contacted to discusseligibility.

  • Clinical, laboratory findings or medical history consistent with:

  1. Other primary degenerative dementia (fronto-temporal dementia, Huntington'sdisease, 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 nervoussystem (syphilis, present hypothyroidism, present vitamin B12 or folatedeficiency, other laboratory values etc.).

  • Any major psychiatric diagnosis, including schizophrenia, bipolar disorder, andcurrent major depressive disorder as per Diagnostic and Statistical Manual of MentalDisorders Fifth Edition

  • Clinically significant, advanced or unstable disease that may interfere with outcomeevaluations.

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: CT1812
Phase: 2
Study Start date:
May 19, 2022
Estimated Completion Date:
November 25, 2024

Study Description

The safety and efficacy of CT1812 at doses of 300 and 100mg will be evaluated over a 24 week double-blind treatment period in patient diagnosed with dementia with Lewy bodies.

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.

Connect with a study center

  • Barrow Neurological Institute

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Banner Sun Health Research Institute

    Sun City, Arizona 85351
    United States

    Site Not Available

  • University of Arizona - Health Sciences Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Parkinson's and Movement Disorder Institute

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Pacific Neuroscience Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • CenExel Rocky Mountain Clinical Research, LLC

    Englewood, Colorado 80113
    United States

    Site Not Available

  • New England Institute for Neurology and Headache (NEINH)

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • JEM Research Institute

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • University of Miami Miller School of Medicine Comprehensive Center for Brain Health

    Boca Raton, Florida 33433
    United States

    Site Not Available

  • Charter Research

    Lady Lake, Florida 32156
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34770
    United States

    Site Not Available

  • Charter Research

    Winter Park, Florida 32792
    United States

    Site Not Available

  • Rush University Medical Center Section of Parkinson Disease and Movement Disorder

    Chicago, Illinois 60612
    United States

    Site Not Available

  • IU Health Neuroscience Center, Goodman Hall

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Josephson Wallack Munshower Neurology, P.C

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • The University of Kansas Alzheimer's Disease Research Center

    Fairway, Kansas 66205
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Headlands Research Eastern Massachusetts, LLC

    Plymouth, Massachusetts 02360
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • UNC Department of Neurology

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Cleveland Clinic Main Campus

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Summit Headlands, LLC

    Portland, Oregon 97210
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Texas Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • Clinical Trial Network

    Houston, Texas 77074
    United States

    Site Not Available

  • University of Virginia Adult Neurology

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Evergreen Health Research

    Kirkland, Washington 98034
    United States

    Site Not Available

  • Universtiy of Washington Department of Neurology

    Seattle, Washington 98104
    United States

    Site Not Available

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