COG1201: Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies
Study Details
Study Description
Brief Summary
Multi-center, randomized, double-blind, placebo-controlled, 6- month study in subjects with mild to moderate Dementia with Lewy Bodies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: CT1812 300 mg CT1812 300 mg |
Drug: CT1812
Orally administered CT1812
|
| Active Comparator: CT1812 100 mg CT1812 100 mg |
Drug: CT1812
Orally administered CT1812
|
| Placebo Comparator: Placebo Placebo |
Drug: CT1812
Orally administered CT1812
|
Outcome Measures
Primary Outcome Measures
- Safety and Tolerability of CT1812 [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
Secondary Outcome Measures
- Montreal Cognitive Assessment Scale (MoCA) [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) [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) [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) [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) [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) [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) [Baseline, 3 months, 6 months]
Computerized battery that captures reaction time, cognitive reaction time, vigilance, and power of attention
- Neuropsychiatric Inventory (NPI) [Baseline, 3 months, 6 months]
Assessment of common behaviors associated with dementia
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
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Men or women 50-85 years of age (inclusive), meeting criteria for probable Dementia with Lewy Bodies (DLB)
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Men willing to comply with acceptable form of contraception or women of non-childbearing
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Willingness to undergo a lumbar puncture (LP) during the screening period and at the end of the 6-month treatment period.
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Formal education of eight or more years.
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Subjects living at home or in an assisted living facility.
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Subjects shall be generally healthy with mobility, vision and hearing sufficient for compliance with testing procedures.
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Must be able to complete all screening evaluations.
Exclusion Criteria:
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Any neurological condition that may be contributing to cognitive impairment other than related to DLB
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History of transient ischemic attacks or stroke within 12 months of screening.
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Hospitalization (except for planned procedures) or change of chronic concomitant medication within one month prior to screening.
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Any major psychiatric diagnosis
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Subjects living in a continuous care nursing facility.
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Contraindication to the MRI examination for any reason.
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Screening MRI of the brain indicative of significant abnormality
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Clinically significant, advanced or unstable disease that may interfere with outcome evaluations
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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.
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Seropositive for human immunodeficiency virus (HIV).
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History of acute/chronic hepatitis B or C and/or carriers of hepatitis B
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Clinically significant abnormalities in screening laboratory tests
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Disability that may prevent the subject from completing all study requirements
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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
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Any disorder that could interfere with the absorption, distribution, metabolism or excretion of drugs
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Nootropic drugs except stable Alzheimer's disease (AD) meds
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Suspected or known drug or alcohol abuse
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Suspected or known allergy to any components of the study treatments.
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Enrollment in another investigational study or intake of investigational drug within the previous 30 days
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Any prior exposure to immunomodulators, anti Aβ vaccines, passive immunotherapies for AD and/or exposure to BACE inhibitors within the past 30 days.
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Anticipated use of nonsteroidal anti-inflammatory drugs (NSAIDs) for more than 2 days per week during the study period
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Contraindication to undergoing an LP
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Any condition, which in the opinion of the investigator or the sponsor makes the subject unsuitable for inclusion.
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Any vaccination within one week of the baseline visit.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Banner Sun Health | Sun City | Arizona | United States | 85251 |
| 2 | Parkinson's and Movement Disorder Institute | Fountain Valley | California | United States | 92708 |
| 3 | New England Institute for Clinical Research | Stamford | Connecticut | United States | 06905 |
| 4 | Josephson Wallack Munshower Neurology, P.C | Indianapolis | Indiana | United States | 46256 |
| 5 | Ohio State University | Columbus | Ohio | United States | 43210 |
| 6 | University of Virginia Adult Neurology | Charlottesville | Virginia | United States | 22903 |
Sponsors and Collaborators
- Cognition Therapeutics
- National Institute on Aging (NIA)
Investigators
- Study Director: Anthony Caggiano, MD, Cognition Therapeutics Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COG1201
- R01AG058660