Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects with Mild to Moderate Dementia with Lewy Bodies
- Registration Number
- NCT05225415
- Lead Sponsor
- Cognition Therapeutics
- Brief Summary
Multi-center, randomized, double-blind, placebo-controlled, 6- month study in subjects with mild to moderate Dementia with Lewy Bodies.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- 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
-
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.
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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
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Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo CT1812 Placebo CT1812 300 mg CT1812 CT1812 300 mg CT1812 100 mg CT1812 CT1812 100 mg
- Primary Outcome Measures
Name Time Method Safety and Tolerability of CT1812 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
- Secondary Outcome Measures
Name Time Method Clinician Assessment of Fluctuation (CAF) Baseline, 3 months, 6 months Assessment of cognitive fluctuations, with range of 1-16, with higher scores representing more severe fluctuations
ADCS-Clinical Global Impression of Change (CGIC) 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
Epworth Sleepiness Scale (ESS) 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
Montreal Cognitive Assessment Scale (MoCA) Baseline, 3 months, 6 months MOCA is a dementia screening assessment with a 0-30 range with lower scores meaning more impairment
Movement Disorder Society - United Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) 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
Cognitive Drug Research Battery (CDR) Baseline, 3 months, 6 months Computerized battery that captures reaction time, cognitive reaction time, vigilance, and power of attention
ADCS - Activities of Daily Living (ADCS-ADL) 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.
Neuropsychiatric Inventory (NPI) Baseline, 3 months, 6 months Assessment of common behaviors associated with dementia
Trial Locations
- Locations (33)
IU Health Neuroscience Center, Goodman Hall
🇺🇸Indianapolis, Indiana, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
CenExel Rocky Mountain Clinical Research, LLC
🇺🇸Englewood, Colorado, United States
UNC Department of Neurology
🇺🇸Chapel Hill, North Carolina, United States
The University of Kansas Alzheimer's Disease Research Center
🇺🇸Fairway, Kansas, United States
Cleveland Clinic Main Campus
🇺🇸Cleveland, Ohio, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
University of Arizona - Health Sciences Center
🇺🇸Tucson, Arizona, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
University of Miami Miller School of Medicine Comprehensive Center for Brain Health
🇺🇸Boca Raton, Florida, United States
Josephson Wallack Munshower Neurology, P.C
🇺🇸Indianapolis, Indiana, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Universtiy of Washington Department of Neurology
🇺🇸Seattle, Washington, United States
Summit Headlands, LLC
🇺🇸Portland, Oregon, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Pacific Neuroscience Institute
🇺🇸Santa Monica, California, United States
Charter Research
🇺🇸Winter Park, Florida, United States
Rush University Medical Center Section of Parkinson Disease and Movement Disorder
🇺🇸Chicago, Illinois, United States
Columbia University
🇺🇸New York, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Virginia Adult Neurology
🇺🇸Charlottesville, Virginia, United States
Evergreen Health Research
🇺🇸Kirkland, Washington, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Headlands Research Eastern Massachusetts, LLC
🇺🇸Plymouth, Massachusetts, United States
New England Institute for Neurology and Headache (NEINH)
🇺🇸Stamford, Connecticut, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Stanford University
🇺🇸Palo Alto, California, United States