Study to Evaluate the Effect of CT1812 Treatment on Amyloid Beta Oligomer Displacement Into CSF in Subjects With Mild to Moderate Alzheimer's Disease
- Registration Number
- NCT03522129
- Lead Sponsor
- Cognition Therapeutics
- Brief Summary
This is a multi-center, Phase 1b, randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to moderate AD.
- Detailed Description
This is a multi-center, Phase 1b, randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to moderate AD. The primary endpoint is the change from the baseline CSF Amyloid beta oligomer concentration after dosing with CT1812 versus placebo. The change from baseline will be measured through a number of exploratory endpoints as indicated below. For each subject, the baseline CSF oligomer concentration will be computed as the average of the measurements from hours -4, -3, -2 and -1 and 0.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Treatment- CT1812 560 mg CT1812 - Placebo Comparator - Placebo Placebo - Active Treatment- CT1812 280 mg CT1812 - Active Treatment- CT1812 90 mg CT1812 -
- Primary Outcome Measures
Name Time Method Measuring the displacement of Amyloid beta oligomers into cerebrospinal fluid (CSF) 48 hours evidence of oligomer displacement as demonstrated by a clear rise in CSF oligomer concentration relative to baseline and placebo
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Clinilabs Drug Development Corporation
🇺🇸New York, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States