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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dementia With Lewy Bodies

In brief

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

Key facts

Study ID

NCT05225415

Run by

Cognition Therapeutics

People needed

130

Starts

2022-05-19

Expected to finish

2024-11-25

Last updated by the study team

2026-03-12

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.