Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies (COG1201)
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|ClinicalTrials.gov Identifier: NCT05225415|
Recruitment Status : Recruiting
First Posted : February 4, 2022
Last Update Posted : June 2, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Dementia With Lewy Bodies||Drug: CT1812||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind, placebo-controlled|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||June 22, 2022|
|Estimated Primary Completion Date :||April 15, 2024|
|Estimated Study Completion Date :||April 15, 2024|
Active Comparator: CT1812 300 mg
CT1812 300 mg
Orally administered CT1812
Active Comparator: CT1812 100 mg
CT1812 100 mg
Orally administered CT1812
Placebo Comparator: Placebo
Orally administered CT1812
- Safety and Tolerability of CT1812 [ Time Frame: 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
- Montreal Cognitive Assessment Scale (MoCA) [ Time Frame: Baseline, 3 months, 6 months ]MOCA is a dementia screening assessment with a 0-30 range with lower scores meaning more impairment
- Epworth Sleepiness Scale (ESS) [ Time Frame: 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
- Clinician Assessment of Fluctuation (CAF) [ Time Frame: 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) [ Time Frame: 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
- ADCS - Activities of Daily Living (ADCS-ADL) [ Time Frame: 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.
- Movement Disorder Society - United Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) [ Time Frame: 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) [ Time Frame: Baseline, 3 months, 6 months ]Computerized battery that captures reaction time, cognitive reaction time, vigilance, and power of attention
- Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 3 months, 6 months ]Assessment of common behaviors associated with dementia
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|Ages Eligible for Study:||50 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
- Any neurological condition that may be contributing to cognitive impairment other than related to DLB.
Clinical, laboratory findings or medical history consistent with:
- Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
- Other neurodegenerative condition (Parkinson's disease, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05225415
|Contact: Diana Executive Assistantemail@example.com|
|Study Director:||Anthony Caggiano, MD||Cognition Therapeutics Inc.|
|Responsible Party:||Cognition Therapeutics|
|Other Study ID Numbers:||
R01AG058660 ( U.S. NIH Grant/Contract )
|First Posted:||February 4, 2022 Key Record Dates|
|Last Update Posted:||June 2, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Lewy Body Disease
Central Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases