This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease.
This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo for approximately 18 months (72 weeks) in approximately 540 participants diagnosed with early Alzheimer's disease Participants will be randomized 1:1:1 to receive either 100mg or 200mg of CT1812 or placebo. CT1812 or placebo will be administered as 2 capsules to be taken orally once daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
540
Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale.
The Clinical Dementia Rating (CDR) is a clinical scale that describes 5 levels of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia as absent, questionable, mild, moderate, or severe (global CDR scores of 0, 0.5, 1, 2, or 3, respectively). The score is based on interviews with the participant and study partner, using a structured interview. A sum of boxes score (CDR-SB) provides an additional measure of change where each category has a maximum possible score of 3 points and the total score is a sum of the category scores giving a total possible score of 0 to 18 with higher scores indicating more impairment.
Time frame: 18 months
Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)
Change from baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13) at 18 months.
Time frame: 18 months
Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI.
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI at 18 months.
Time frame: 18 months
Cerebrospinal fluid (CSF) concentrations of beta-amyloid (Aβ) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin.
Change from baseline at 18 months.
Time frame: 18 months
Plasma measures of Aβ fragments, ptau, and Neurofilament light (NfL)
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University of Alabama at Birmingham
Birmingham, Alabama, United States
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Irvine, California, United States
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Palo Alto, California, United States
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Sacramento, California, United States
Yale University
New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
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Delray Beach, Florida, United States
...and 40 more locations
Change from baseline at 18 months.
Time frame: 18 months
Volumetric Magnetic Resonance Imaging (MRI) including hippocampal and whole brain volume change
Change from baseline at 18 months.
Time frame: 18 months