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 : January 26, 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
- Clinical 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects or their Legally Authorized Representative (LAR) must provide written informed consent to the study procedures prior to any study procedures.
- Subjects must have a caregiver/ study partner who in the opinion of the site principal investigator, has contact with the study subject for a sufficient number of hours per week to provide informative responses on the protocol assessments, oversee the administration of study drug, and is willing and able to participate in all clinic visits and some study assessments.
- Men or women 50-85 years of age (inclusive), meeting criteria for probable Dementia with Lewy Bodies (DLB)
- Men willing to comply with acceptable form of contraception or women of non-childbearing
- Willingness to undergo a lumbar puncture (LP) during the screening period and at the end of the 6-month treatment period.
- Formal education of eight or more years.
- Subjects living at home or in an assisted living facility.
- Subjects shall be generally healthy with mobility, vision and hearing sufficient for compliance with testing procedures.
- Must be able to complete all screening evaluations.
- Any neurological condition that may be contributing to cognitive impairment other than related to DLB
- History of transient ischemic attacks or stroke within 12 months of screening.
- Hospitalization (except for planned procedures) or change of chronic concomitant medication within one month prior to screening.
- Any major psychiatric diagnosis
- Subjects living in a continuous care nursing facility.
- Contraindication to the MRI examination for any reason.
- Screening MRI of the brain indicative of significant abnormality
- Clinically significant, advanced or unstable disease that may interfere with outcome evaluations
- History of cancer within 3 years of screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months.
- Seropositive for human immunodeficiency virus (HIV).
- History of acute/chronic hepatitis B or C and/or carriers of hepatitis B
- Clinically significant abnormalities in screening laboratory tests
- Disability that may prevent the subject from completing all study requirements
- Within 4 weeks of screening visit or during the course of the study, concurrent treatment with antipsychotic agents, antiepileptics, centrally active anti-hypertensive drugs, sedatives, opioids, mood stabilizers, or benzodiazepines
- Any disorder that could interfere with the absorption, distribution, metabolism or excretion of drugs
- Nootropic drugs except stable Alzheimer's disease (AD) meds
- Suspected or known drug or alcohol abuse
- Suspected or known allergy to any components of the study treatments.
- Enrollment in another investigational study or intake of investigational drug within the previous 30 days
- Any prior exposure to immunomodulators, anti Aβ vaccines, passive immunotherapies for AD and/or exposure to BACE inhibitors within the past 30 days.
- Anticipated use of nonsteroidal anti-inflammatory drugs (NSAIDs) for more than 2 days per week during the study period
- Contraindication to undergoing an LP
- Any condition, which in the opinion of the investigator or the sponsor makes the subject unsuitable for inclusion.
- Any vaccination within one week of the baseline visit.
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: Asra Warsiemail@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:||January 26, 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