Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies
Multi-center, randomized, double-blind, placebo-controlled, 6- month study in subjects with mild to moderate Dementia with Lewy Bodies.
- Dementia With Lewy Bodies
- Eligible Ages
- Between 50 Years and 85 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Double-blind, placebo-controlled
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
CT1812 300 mg
|CT1812 300 mg||
CT1812 100 mg
|CT1812 100 mg||
- Cognition Therapeutics
Study ContactAsra Warsi
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.