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

NCT05225415 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: COG1201R01AG071643
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 34

Brief Summary

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

Conditions

Dementia With Lewy Bodies

Keywords

Dementia

Outcome Measures

Primary Outcomes (1)

• Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)

  All adverse events (AE) summaries were restricted to TEAEs, which were defined as those AEs that occurred on or after the date of first dose and those existing AEs that worsened during the study. If it could not be determined whether the AE was treatment-emergent due to a partial onset date, then it was counted as such. Verbatim terms were mapped to System Organ Class (SOC) and preferred terms using MedDRA version 24.1.

  Up to 210 Days

Secondary Outcomes (8)

• Montreal Cognitive Assessment Scale (MoCA)

  Baseline, Day 28, Day 98, and Day 182

• Epworth Sleepiness Scale (ESS)

  Baseline, Day 28, Day 98, and Day 182

• Clinician Assessment of Fluctuation (CAF)

  Baseline, Day 28, Day 98, and Day 182

• Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)

  Day 28, Day 98, and Day 182

• ADCS - Activities of Daily Living (ADCS-ADL)

  Baseline, Day 28, Day 98, and Day 182

Study Arms (3)

CT1812 300 mg

ACTIVE COMPARATOR

CT1812 300 mg

Drug: CT1812

CT1812 100 mg

ACTIVE COMPARATOR

CT1812 100 mg

Drug: CT1812

Placebo

PLACEBO COMPARATOR

Placebo

Drug: CT1812

Interventions

CT1812 DRUG

Orally administered CT1812

CT1812 100 mg; CT1812 300 mg; Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women 50-85 years of age (inclusive), meeting criteria for probable Dementia with Lewy Bodies (DLB).
• MMSE 18-27 inclusive

You may not qualify if:

• 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:
• Other primary degenerative dementia (fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
• Other neurodegenerative condition (amyotrophic lateral sclerosis, etc.).
• Seizure disorder.
• 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.

Sponsors & Collaborators

• Cognition Therapeutics: lead
• National Institute on Aging (NIA): collaborator

Study Sites (34)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

University of Arizona - Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Pacific Neuroscience Institute

Santa Monica, California, 90404, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

CenExel Rocky Mountain Clinical Research, LLC

Englewood, Colorado, 80113, United States

Location

New England Institute for Neurology and Headache (NEINH)

Stamford, Connecticut, 06905, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

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

Boca Raton, Florida, 33433, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Charter Research

Lady Lake, Florida, 32156, United States

Location

Renstar Medical Research

Ocala, Florida, 34770, United States

Location

Charter Research

Winter Park, Florida, 32792, United States

Location

Rush University Medical Center Section of Parkinson Disease and Movement Disorder

Chicago, Illinois, 60612, United States

Location

IU Health Neuroscience Center, Goodman Hall

Indianapolis, Indiana, 46202, United States

Location

Josephson Wallack Munshower Neurology, P.C

Indianapolis, Indiana, 46256, United States

Location

The University of Kansas Alzheimer's Disease Research Center

Fairway, Kansas, 66205, United States

Location

University of Kentucky

Lexington, Kentucky, 40504, United States

Location

Headlands Research Eastern Massachusetts, LLC

Plymouth, Massachusetts, 02360, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia University

New York, New York, 10032, United States

Location

UNC Department of Neurology

Chapel Hill, North Carolina, 27599, United States

Location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Summit Headlands, LLC

Portland, Oregon, 97210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

University of Virginia Adult Neurology

Charlottesville, Virginia, 22903, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Evergreen Health Research

Kirkland, Washington, 98034, United States

Location

Universtiy of Washington Department of Neurology

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Galvin JE, Tolea MI, Scharre DW, Hamby ME, Iaci JF, Grundman M, Caggiano AO. Phase 2 study of zervimesine (CT1812) in participants with mild-to-moderate dementia with Lewy bodies (DLB). Alzheimers Dement. 2025 Dec;21(12):e71004. doi: 10.1002/alz.71004.

  PMID: 41416579 DERIVED

MeSH Terms

Conditions

Lewy Body Disease; Dementia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Anthony Caggiano
• Organization: Cogntion Therapeutics Inc

acaggiano@cogrx.com

914-221-6730

Study Officials

• Anthony Caggiano, MD

  Cognition Therapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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
• Expanded Access: Yes

Model Details: Double-blind, placebo-controlled

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 4, 2022
• Study Start: May 19, 2022
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-02

Locations

US (34)