Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies (COG1201)

April 12, 2024 updated by: Cognition Therapeutics

A Randomized, Double-blind, Placebo-controlled, Phase 2, 6-month Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Barrow Neurological Institute
        • Contact:
        • Principal Investigator:
          • Marwan Sabbagh
      • Sun City, Arizona, United States, 85351
      • Tucson, Arizona, United States, 85724
        • Terminated
        • University of Arizona - Health Sciences Center
    • California
      • Fountain Valley, California, United States, 92708
        • Withdrawn
        • Parkinson's and Movement Disorder Institute
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Sharon J Sha
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Pacific Neuroscience Institute
        • Contact:
          • Marisol Savage
          • Phone Number: 213-712-7731
        • Principal Investigator:
          • Melita Petrossian
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • CenExel Rocky Mountain Clinical Research, LLC
        • Principal Investigator:
          • Rajeev Kumar, MD
        • Contact:
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Recruiting
        • New England Institute for Neurology and Headache (NEINH)
        • Contact:
          • Katie Nejati
          • Phone Number: 131 203-914-1903
        • Contact:
        • Principal Investigator:
          • Peter McAllister
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • JEM Research Institute
        • Principal Investigator:
          • Linda Pao, MD
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Parkinson's Disease and Movement Disorders Center of Boca Raton
        • Contact:
        • Principal Investigator:
          • Stuart Isaacson
      • Boca Raton, Florida, United States, 33433
        • Recruiting
        • University of Miami Miller School of Medicine Comprehensive Center for Brain Health
        • Contact:
        • Principal Investigator:
          • Magdalena Tolea
      • Lady Lake, Florida, United States, 32156
      • Ocala, Florida, United States, 34770
        • Recruiting
        • Renstar Medical Research
        • Principal Investigator:
          • Anette V Nieves
        • Contact:
      • Winter Park, Florida, United States, 32792
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center Section of Parkinson Disease and Movement Disorder
        • Contact:
          • Phone Number: 312-563-2900
        • Principal Investigator:
          • Jori Fleisher
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Josephson Wallack Munshower Neurology, P.C
        • Contact:
        • Principal Investigator:
          • Kristi George, MD
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • IU Health Neuroscience Center, Goodman Hall
        • Principal Investigator:
          • Jared Brosch
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Active, not recruiting
        • The University of Kansas Alzheimer's Disease Research Center
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Recruiting
        • University of Kentucky
        • Contact:
        • Principal Investigator:
          • Greg Jicha
        • Contact:
    • Massachusetts
      • Plymouth, Massachusetts, United States, 02360
        • Recruiting
        • Headlands Research Eastern Massachusetts, LLC
        • Principal Investigator:
          • Donald Marks
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Bradley F Boeve
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Contact:
        • Principal Investigator:
          • Lawrence S Honig
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Department of Neurology
        • Contact:
        • Principal Investigator:
          • Andrea Bozoki
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Main Campus
        • Contact:
          • Babak Tousi
          • Phone Number: 216-237-6400
        • Principal Investigator:
          • Babak Tousi
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Contact:
        • Principal Investigator:
          • Douglas W Scharre
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph F, Quinn
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Summit Headlands, LLC
        • Principal Investigator:
          • Scott Losk
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern
        • Principal Investigator:
          • Brendan Kelley
        • Contact:
      • Houston, Texas, United States, 77074
        • Recruiting
        • Clinical Trial Network
        • Principal Investigator:
          • Nelson Berrios
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Adult Neurology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anelyssa D'Abreu
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Principal Investigator:
          • Matthew Barrett
        • Contact:
    • Washington
      • Kirkland, Washington, United States, 98034
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Universtiy of Washington Department of Neurology
        • Principal Investigator:
          • Kimiko Domoto-Reilly
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men or women 50-85 years of age (inclusive), meeting criteria for probable Dementia with 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 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: CT1812
Orally administered CT1812
Active Comparator: CT1812 300 mg
Drug: CT1812
Orally administered CT1812
Active Comparator: CT1812 100 mg
Drug: CT1812
Orally administered CT1812

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of CT1812
Time Frame: Baseline, Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 98, Day 126, Day 154, Day 182, Day 210
Incidence and Severity of Adverse Events
Baseline, Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 98, Day 126, Day 154, Day 182, Day 210

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment Scale (MoCA)
Time Frame: Baseline, 3 months, 6 months
MOCA is a dementia screening assessment with a 0-30 range with lower scores meaning more impairment
Baseline, 3 months, 6 months
Epworth Sleepiness Scale (ESS)
Time Frame: Baseline, 3 months, 6 months
The ESS is an assessment of subjective sleepiness over the prior two weeks. The scale is on 4 point scale (0 = no chance of dozing; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing) An ESS score > 10 is considered consistent with excessive daytime sleepiness
Baseline, 3 months, 6 months
ADCS-Clinical Global Impression of Change (CGIC)
Time Frame: Baseline, 3 months, 6 months
The ADCS-CGIC is a 7-point scale similar to other global change scales, where a higher score indicates marked improvement
Baseline, 3 months, 6 months
ADCS - Activities of Daily Living (ADCS-ADL)
Time Frame: Baseline, 3 months, 6 months
Assessment of functional impairment in activities of daily living. The total score range is from 0-78 with lower scores indicating greater functional impairment.
Baseline, 3 months, 6 months
Movement Disorder Society - United Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III)
Time Frame: Baseline, 3 months, 6 months
This exam covers 18 motor signs associated with parkinsonism covering bradykinesia, rigidity, tremor, and gait with a range of scores from 0-136, with higher scores supporting more severe symptoms. A score of 6 or greater suggest the presence of parkinsonism
Baseline, 3 months, 6 months
Cognitive Drug Research Battery (CDR)
Time Frame: Baseline, 3 months, 6 months
Computerized battery that captures reaction time, cognitive reaction time, vigilance, and power of attention
Baseline, 3 months, 6 months
Neuropsychiatric Inventory (NPI)
Time Frame: Baseline, 3 months, 6 months
Assessment of common behaviors associated with dementia
Baseline, 3 months, 6 months
Clinician Assessment of Fluctuation (CAF)
Time Frame: Baseline, 3 months, 6 months
Assessment of cognitive fluctuations, with range of 1-16, with higher scores representing more severe fluctuations
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cognition Therapeutics

Collaborators

National Institute on Aging (NIA)

Investigators

  • Study Director: Anthony Caggiano, MD, Cognition Therapeutics Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2022

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COG1201
  • R01AG071643 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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