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15mg T3D-959 for Alzheimer's Disease

Phase 2
Waitlist Available
Research Sponsored by T3D Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Clinical Dementia Rating is 0.5 to 2.0 at screening and Clinical Dementia Rating - Sum of Boxes is ≥ 3 at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks (subjects are on active treatment for 24 weeks followed by a 4-week follow-up)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in improving Alzheimer's symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a clinical dementia rating of 0.5 to 2.0 or a sum of boxes ≥ 3 at screening.
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You have mild-to-moderate cognitive impairment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks (subjects are on active treatment for 24 weeks followed by a 4-week follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks (subjects are on active treatment for 24 weeks followed by a 4-week follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of T3D-959 on cognition
Efficacy of T3D-959 on function
Safety and tolerability of T3D-959
Secondary outcome measures
Efficacy of T3D-959 on executive function
Efficacy of T3D-959 on plasma Aβ 42/40 ratio biomarker level

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
15mg T3D-959
2021
Completed Phase 2
~250
30 mg T3D-959
2021
Completed Phase 2
~250
45 mg T3D-959
2021
Completed Phase 2
~250

Find a Location

Who is running the clinical trial?

T3D Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,655 Previous Clinical Trials
28,003,920 Total Patients Enrolled
Clinilabs, Inc.OTHER
8 Previous Clinical Trials
399 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA ratified 15mg T3D-959 for medical use?

"Based on the available data, our team has assigned 15mg T3D-959 a safety rating of 2. This assessment is due to it being in Phase 2 clinical trials - there are some findings that suggest its security but none supporting efficacy."

Answered by AI

Are there vacancies in the current clinical trial that could be filled by applicants?

"Clinicaltrials.gov has officially noted that this investigation, which was originally advertised on March 1st 2021 before being modified most recently on July 27th 2022, is presently not accepting patients into the trial. Nevertheless, there are 546 other studies actively recruiting individuals at this moment in time."

Answered by AI

Do I qualify to participate in this medical experiment?

"This clinical trial seeks to enrol 256 individuals with Alzheimer's disease between the ages of 50 and 90. To be accepted, applicants must meet certain criteria including a Clinical Dementia Rating score ranging from 0.5 - 2.0, have an identified adult caregiver who can provide reliable information regarding the subject's cognition, function and behaviour on a daily basis throughout the duration of the study, as well as having mild-to-moderate cognitive impairment based upon their Mini Mental State Examination (MMSE) score at screening which should fall within 14 - 26 range."

Answered by AI

What is the geographical scope of this experiment's implementation?

"Patients can be enrolled in this trial at Community Hospital of Anderson and Madison County Inc. in Anderson, Indiana, ANI Neurology, PLLC dba Alzheimer's Memory Center in Charlotte, North carolina, Las Vegas Medical Research in Las Vegas Nevada as well as other 38 sites."

Answered by AI

Is this investigation recruiting participants aged less than 55 years?

"As specified in the trial's selection guidelines, patients between 50 and 90 years old are eligible to participate."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
ClinCloud Clinical Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
~62 spots leftby Mar 2025