NCT04251182

Clinical Study Evaluating Efficacy and Safety of T3D-959 in Mild-to-moderate AD Subjects

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: T3D Therapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	15mg T3D-959	Oral administration once daily in the morning
DRUG	30 mg T3D-959	Oral administration once daily in the morning
DRUG	45 mg T3D-959	Oral administration once daily in the morning
DRUG	Placebos	Oral administration once daily in the morning

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-01-20
• Completion: 2023-02-17
• First posted: 2020-01-31
• Last updated: 2024-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study