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

Phase 2

Active, not recruiting

• Conditions: Dementia With Lewy Bodies
• Interventions: Drug: CT1812

• 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.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-04
• Study Start: 2022-05-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 130

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

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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.

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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