This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD).
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD). This Phase 2 study is designed to evaluate the safety of two doses of CT1812 administered once daily for 6 months in adults aged 50 to 85 who have been diagnosed with mild to moderate Alzheimer's disease. Randomized participants will receive 100 mg of CT1812, 300 mg of CT1812, or placebo once daily for 182 days. Exploratory endpoints that evaluate the effect of CT1812 on biomarkers are also included.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
153
Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)
Adverse events were captured from the start of study-related procedures at Visit 1 (including diagnostic assessments or signing of ICF) onward during the course of this study. Adverse events were coded using MedDRA Version 27.0.TEAEs are events that occurred or worsened on or after the first application of study drug. Participants are counted once for each system organ class (SOC) and once for each preferred term (PT).
Time frame: Up to 210 Days
Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs).
Adverse events were captured from the start of study-related procedures at Visit 1 (including diagnostic assessments or signing of ICF) onward during the course of this study. Adverse events were coded using MedDRA Version 27.0.TEAEs are events that occurred or worsened on or after the first application of study drug. Participants are counted once for each system organ class (SOC) and once for each preferred term (PT).
Time frame: Up to 210 Days
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers
Change from baseline in CSF-Aβ, Tau, phospho-Tau, neurogranin, synaptotagmin, synaptosomal-associated protein-25 (SNAP25), neurofilament light chain (NfL), and Aβ-oligomers.Change from baseline is calculated as the observed value minus the baseline value.
Time frame: Baseline to Day 182
Amyloid Beta 1-42/Amyloid Beta 1-40 (Aβ42/40) in the Cerebrospinal Fluid (CSF) Biomarkers
Ratio of Amyloid Beta 1-42 (Aβ42) to Amyloid Beta 1-40 (Aβ40) Concentration from Baseline to Day 182.
Time frame: Baseline to Day 182
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21st Century Neurology/ Xenoscience Inc.
Phoenix, Arizona, United States
Imaging Endpoints
Scottsdale, Arizona, United States
Ki Health Partners, LLC dba New England Institute for Clinical Research
Stamford, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
Charter Research
Lady Lake, Florida, United States
ClinCloud, LLC
Maitland, Florida, United States
Allied Biomedical Research Institute
Miami, Florida, United States
Compass Research LLC- Bioclinica Research
The Villages, Florida, United States
ClinCloud
Viera, Florida, United States
Alzheimer's Memory Center
Charlotte, North Carolina, United States
...and 22 more locations