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

Cognition Therapeutics130 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

130

Conditions

Dementia With Lewy Bodies

Interventions

CT1812DRUG

Orally administered CT1812

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (34)

Outcomes

Primary Outcomes

Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)

All adverse events (AE) summaries were restricted to TEAEs, which were defined as those AEs that occurred on or after the date of first dose and those existing AEs that worsened during the study. If it could not be determined whether the AE was treatment-emergent due to a partial onset date, then it was counted as such. Verbatim terms were mapped to System Organ Class (SOC) and preferred terms using MedDRA version 24.1.

Time frame: Up to 210 Days

Secondary Outcomes

Montreal Cognitive Assessment Scale (MoCA)

MOCA is a dementia screening assessment with a 0-30 range with lower scores meaning more impairment

Time frame: Baseline, Day 28, Day 98, and Day 182

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) Total score sums up all sub-scores and can range from 0 to 24. A higher score is associated with increased sleepiness. An ESS score ≥10 is considered abnormal and consistent with excessive daytime sleepiness An ESS score \> 10 is considered consistent with excessive daytime sleepiness

Time frame: Baseline, Day 28, Day 98, and Day 182

Clinician Assessment of Fluctuation (CAF)

Assessment of cognitive fluctuations, with range of 1-16, with higher scores representing more severe fluctuations

Time frame: Baseline, Day 28, Day 98, and Day 182

Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)

The ADCS-CGIC is a 7-point scale similar to other global change scales, where a higher score indicates marked improvement. The 7 responses and corresponding numeric scores for each response of the ADCS-CGIC are: Marked improvement (1), Moderate improvement (2), Minimal improvement (3), No change (4), Minimal worsening (5), Moderate worsening (6), Marked worsening (7). The observed scores at each visit were summarized. A responder was defined as a participant who responded as "Marked improvement, Moderate improvement, Minimal improvement, No change" and non-responder was defined as a participant who responded as "Minimal worsening, Moderate worsening, Marked worsening."

Data from ClinicalTrials.gov

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