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

Dementia With Lewy Bodies Clinical Trial

— COG1201  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05225415
• Other study ID #: COG1201
• Secondary ID: R01AG071643
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 19, 2022
• Est. completion date: November 2024

Study information

• Verified date: May 2024
• Source: Cognition Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Dementia With Lewy Bodies
• Lewy Body Disease

Intervention

Drug:
• CT1812
Orally administered CT1812

Locations

Country	Name	City	State
United States	JEM Research Institute	Atlantis	Florida
United States	University of Colorado	Aurora	Colorado
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	University of Miami Miller School of Medicine Comprehensive Center for Brain Health	Boca Raton	Florida
United States	UNC Department of Neurology	Chapel Hill	North Carolina
United States	University of Virginia Adult Neurology	Charlottesville	Virginia
United States	Rush University Medical Center Section of Parkinson Disease and Movement Disorder	Chicago	Illinois
United States	Cleveland Clinic Main Campus	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	CenExel Rocky Mountain Clinical Research, LLC	Englewood	Colorado
United States	The University of Kansas Alzheimer's Disease Research Center	Fairway	Kansas
United States	Clinical Trial Network	Houston	Texas
United States	IU Health Neuroscience Center, Goodman Hall	Indianapolis	Indiana
United States	Josephson Wallack Munshower Neurology, P.C	Indianapolis	Indiana
United States	Evergreen Health Research	Kirkland	Washington
United States	Charter Research	Lady Lake	Florida
United States	University of Kentucky	Lexington	Kentucky
United States	Columbia University	New York	New York
United States	Renstar Medical Research	Ocala	Florida
United States	Stanford University	Palo Alto	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Headlands Research Eastern Massachusetts, LLC	Plymouth	Massachusetts
United States	Oregon Health and Science University	Portland	Oregon
United States	Summit Headlands, LLC	Portland	Oregon
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Pacific Neuroscience Institute	Santa Monica	California
United States	Universtiy of Washington Department of Neurology	Seattle	Washington
United States	New England Institute for Neurology and Headache (NEINH)	Stamford	Connecticut
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	University of Arizona - Health Sciences Center	Tucson	Arizona
United States	Charter Research	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Cognition Therapeutics	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of CT1812	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	Montreal Cognitive Assessment Scale (MoCA)	MOCA is a dementia screening assessment with a 0-30 range with lower scores meaning more impairment	Baseline, 3 months, 6 months
Secondary	Epworth Sleepiness Scale (ESS)	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
Secondary	Clinician Assessment of Fluctuation (CAF)	Assessment of cognitive fluctuations, with range of 1-16, with higher scores representing more severe fluctuations	Baseline, 3 months, 6 months
Secondary	ADCS-Clinical Global Impression of Change (CGIC)	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
Secondary	ADCS - Activities of Daily Living (ADCS-ADL)	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
Secondary	Movement Disorder Society - United Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III)	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
Secondary	Cognitive Drug Research Battery (CDR)	Computerized battery that captures reaction time, cognitive reaction time, vigilance, and power of attention	Baseline, 3 months, 6 months
Secondary	Neuropsychiatric Inventory (NPI)	Assessment of common behaviors associated with dementia	Baseline, 3 months, 6 months