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

Recruiting in Palo Alto (17 mi)

+46 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: T3D Therapeutics, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Blake Swearingen, MS

Principal Investigator

T3D Therapeutics, Inc.

Eligibility Criteria

Inclusion Criteria

You have mild-to-moderate cognitive impairment.

Have a reliable caregiver, an identified adult who, in the opinion of the investigator has sufficient contact to knowledgeably report on the subject's daily cognition, function, behavior, safety, compliance and adherence. Same caregiver(s) must assist the subject throughout the duration of the trial.

You have a clinical dementia rating of 0.5 to 2.0 or a sum of boxes ≥ 3 at screening.

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Treatment Details

Interventions

15mg T3D-959 (Other)
30 mg T3D-959 (Other)
45 mg T3D-959 (Other)
Placebos (Other)

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 45mg T3D-959Experimental Treatment1 Intervention

T3D-959 45 mg dose: Subjects will ingest three size 0, 15mg capsules once per day in the morning.

Group II: 30mg T3D-959Experimental Treatment1 Intervention

T3D-959 30 mg dose: Subjects will ingest two size 0, 15mg capsules and one placebo capsule once per day in the morning.

Group III: 15mg T3D-959Experimental Treatment1 Intervention

T3D-959 15 mg dose: T3D-959 is a small molecule dual nuclear receptor agonist that regulates transcription of genes, in particular those involved in glucose energy and lipid metabolism. T3D-959 is 15-times more potent for PPAR delta than for the secondary target of the drug, PPAR gamma. The 15 mg strength contains 15mg T3D-959, pregelatinized starch NF, magnesium stearate NF, and size 0, hard gelatin, white/white, opaque, unmarked capsules. Subjects will ingest one size 0, 15mg capsule and two placebo capsules once per day in the morning.

Group IV: PlaceboPlacebo Group1 Intervention

Placebo, matching T3D-959 active capsules, is pregelatinized starch NF, magnesium stearate NF, and size 0, hard gelatin, white/white, opaque, unmarked capsules. Subjects randomized to placebo will ingest three size 0 placebo capsules once per day in the morning.