Phase 2b/3 Study of T3D-959 for Mild-to-Moderate Alzheimer's Disease

This study is testing an experimental drug called T3D-959 for people with mild-to-moderate Alzheimer's disease. T3D-959 is a small molecule that works by regulating genes involved in how your body uses energy and fats. Researchers want to see if T3D-959 is safe and effective, and if it can help change the course of the disease. You would take T3D-959 or a placebo (an inactive substance) once a day for 78 weeks. To join, you need to be between 50 and 90 years old, have a caregiver, and have a biological diagnosis of Alzheimer's disease confirmed by a plasma biomarker (a test that looks for specific substances in your blood). Success will be measured by changes in your thinking abilities (ADAS-Cog13) and daily living skills (ADCS-iADL) after 78 weeks. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study with 376 planned participants. Participants will be assigned by chance to receive either T3D-959 or a placebo.
What's involved
You would take study medication once daily for 78 weeks. Safety, effectiveness, and other assessments will be evaluated during this time.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for four weeks after the end of the 78-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06964230

A Phase 2b/3 Clinical Study Evaluating T3D-959 in Mild-to-Moderate Alzheimer's Disease Subjects

Not Yet Recruiting
PHASE2Ages 50–90InterventionalTreatment
T3D Therapeutics, Inc.
~376 participants
Updated 2025-05-09 on ClinicalTrials.gov
What's tested:T3D-959Placebo Comparator

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline to end of treatment in ADAS-Cog13 and ADCS-iADL
Measured over 78 weeks
Alzheimer's Disease
1 sites across 1 states
North Carolina1
  • John Didsbury, Chief Executive Officer, Ph.D · STUDY_DIRECTOR · T3D Therapeutics, Inc.

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  • Change from baseline to end of treatment in ADAS-Cog13 and ADCS-iADL78 weeks

    Primary Efficacy Endpoint • Co-primary endpoints of Alzheimer's Disease Assessment Scale cognitive subscale, 13-items (ADAS-Cog13) with a score range of 0-85 (higher scores indicating greater dysfunction) and Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living (ADCS-iADL) with a score range of 0-56 (lower scores indicating worse performance), in subjects with a clinical diagnosis of mild-to-moderate AD and biological diagnosis of AD pathology. ADAS-cog 13