Central States Research | Tulsa, OK
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About
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.
Full description
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.
Enrollment
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Inclusion criteria
Exclusion criteria
Screening MRI of the brain indicative of significant abnormality.
Clinically significant abnormalities in screening laboratory tests.
Clinical or laboratory findings consistent with:
A participant known to be actively infected with hepatitis B or hepatitis C at screening. History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C [HCV] antibody). Participants who have evidence of resolved hepatitis infection (e.g., HCV RNA negative) may be considered following discussion with the Medical Monitor.
A current DSM-V diagnosis of active major depression or GDS > 6, schizophrenia, or bipolar disorder.
Primary purpose
Allocation
Interventional model
Masking
540 participants in 3 patient groups, including a placebo group
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Central trial contact
Diana Executive Assistant
Data sourced from clinicaltrials.gov
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