T3D-959 for Alzheimer's Disease

Overseen By John Didsbury, Ph.D., Chief Executive Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: T3D Therapeutics, Inc.

Must not be taking: Antidepressants, Antipsychotics

Disqualifiers: Psychiatric illness, Stroke, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 78 weeks

376 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) and stability of all concurrent medications according to the exclusion criteria. You may need to stop taking some medications, but the specific details are not provided in the protocol.

What is the purpose of this trial?

This study is a Phase 2b/3 clinical trial of a new candidate drug (T3D-959) to treat patients with mild-to-moderate Alzheimer's. The aims of the trial are to affirm potential therapeutic efficacy and safety observed in earlier clinical trials and assess the potential to modify the course of disease. The drug will be compared to placebo and administered orally to patients once a day for 78 weeks.

Research Team

John Didsbury, Chief Executive Officer, Ph.D

Principal Investigator

T3D Therapeutics, Inc.

Eligibility Criteria

This trial is for individuals with mild-to-moderate Alzheimer's Disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a caregiver or family member who can assist them throughout the study.

Inclusion Criteria

Subject (or legal representative) and caregiver must sign an Informed Consent to participate in the study

Subject has a caregiver who can report on the subject's cognition, function, behavior, safety, compliance, and adherence

Meets criteria for mild-to-moderate cognitive impairment with MMSE score of 14 through 26

Exclusion Criteria

Subject has a current diagnosis of a significant psychiatric illness per DSM-V

Other significant pathological findings on brain MRI

With glycosylated hemoglobin (HbA1c) ≥ 10 at screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive T3D-959 or placebo orally once a day

78 weeks

Regular visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• T3D-959

Trial Overview The trial is testing T3D-959, an oral medication that might help treat Alzheimer's. It will be given daily for 78 weeks and compared to a placebo to see if it's effective and safe, and whether it can alter the disease's progression.

Participant Groups

Group I: 30mg T3D-959 Experimental Treatment 1 Intervention

Experimental: 30mg T3D-959 Arm Description: Experimental: T3D-959 30 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 two size 0, 15mg capsules once per day in the morning.

Group II: Placebo, matching T3D-959 active capsules Placebo Group 1 Intervention

Placebo Comparator: 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 two size 0 placebo capsules once per day in the morning.

Who Is Running the Clinical Trial?

T3D Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

290+