CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
T3D-959drug
Likely dose
T3D-959 3mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02560753
NCT02560753Phase 2Completed
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Phase 2a Feasibility Study of T3D-959 in Subjects With Mild to Moderate Alzheimer's Disease

T3D Therapeutics, Inc.·interventional·Posted Sep 25, 2015·Updated Jul 30, 2018

In Brief

A Phase 2 clinical trial evaluating T3D-959 for Alzheimer's Disease. Completed, enrolled 36 participants across 3 sites.

Detailed Summary

The study is a randomized, parallel, 4-dose design in subjects with mild-to-moderate Alzheimer's Disease. Subjects will be randomized to one of 4 doses of T3D-959. Subjects will be evaluated for changes from baseline in cerebral metabolic rate of glucose (FDG-PET imaging), functional connectivity of the hippocampus (BOLD-fMRI), and cognitive function (ADAS-Cog11 and DSST) as well as assessed for safety and tolerability to T3D-959. An expanded access extension is planed to provide access to study medication to subjects who have completed the main study and requested continued use.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 25, 2015
Enrollment StartJul 1, 2015
Primary CompletionMay 30, 2016
Study CompletionJun 30, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.8 years ago

Interventions

T3D-959drug

The 3mg dosage is supplied as 1mg capsules (three capsules, taken once daily by mouth) The 10mg dosage is supplied as 5mg capsules (two capsules, taken once daily by mouth) The 30mg dosage is supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth) The 90mg dosage is supplied as 15mg capsules (six capsules, taken once daily by mouth)