A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Evaluate the Safety and Efficacy of Three Dose Strengths of T3D-959 in Subjects with Mild-to-Moderate Alzheimer's Disease.
Study Design \& Methods: Phase 2 multi-center, randomized, double blind, placebo-controlled study of T3D959 15 mg, 30 mg, 45 mg, or matching placebo administered orally once daily for 24 weeks. There will be equal allocation of subject numbers across the four groups. Stratified randomization will be conducted on the basis of ApoE4 genotype so that subjects are randomized into one of the four dose groups within each stratum of ApoE4 status: ApoE4-positive (at least one E4 allele) vs ApoE4-negative (no E4 alleles). Following informed consent, subjects will enter the screening phase of the study. Once eligibility is confirmed and before the start of the first dose of study drug, subjects will be randomized on a 1:1:1:1 basis to placebo or T3D959 treatment (15mg, 30mg, 45mg) for the 24-week treatment period. Investigators, subjects, and caregivers will be blinded to the treatment assignment. Study schedule visits: screening, baseline, weeks 4, 8, 16, 24 and 28 (F/U visit)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
Oral administration once daily in the morning
Oral administration once daily in the morning
Oral administration once daily in the morning
T3D Therapeutics
Durham, North Carolina, United States
Efficacy of T3D-959 on cognition
Change in cognition as assessed by The Alzheimer's Disease Assessment Scale 11-task cognitive subscale (ADAS-Cog11) from baseline to end of treatment visit, compared to placebo
Time frame: 28 weeks (Subjects are on active treatment for 24 weeks followed by a 4-week follow-up)
Efficacy of T3D-959 on function
Change in global function as assessed by Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) from baseline to end of treatment visit, compared to placebo
Time frame: 28 weeks (Subjects are on active treatment for 24 weeks followed by a 4-week follow-up)
Safety and tolerability of T3D-959
Safety will be assessed by 1) AEs, clinical labs, ECG, weight, vital signs 2) Geriatric Depression Scale (GDS) 3)Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 28 weeks (Subjects are on active treatment for 24 weeks followed by a 4-week follow-up)
Efficacy of T3D-959 on executive function
Change in executive function as assessed by the Digit Symbol Coding Test (DSCT) from baseline to end of treatment visit, compared to placebo
Time frame: 28 weeks (Subjects are on active treatment for 24 weeks followed by a 4-week follow-up)
Efficacy of T3D-959 on plasma Aβ 42/40 ratio biomarker level
Change in Aβ 42/40 ratio plasma biomarker from baseline to end of treatment visit, compared to placebo
Time frame: 28 weeks (Subjects are on active treatment for 24 weeks followed by a 4-week follow-up)
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Oral administration once daily in the morning