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Alzheimer DiseasePhase 2NCT04251182

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

A Phase 2 study testing 15mg T3D-959, 30 mg T3D-959 and 45 mg T3D-959 in people with Alzheimer Disease, run by T3D Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer Disease
What is being tested?
15mg T3D-959, 30 mg T3D-959 and 45 mg T3D-959
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
1 siteUnited States
Study dates
1 Mar 2021to 17 Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Have a clinical diagnosis of mild-to-moderate AD (Stage 4 or 5) according to the NIA-AA (National Institute of Aging - Alzheimer's Association) criteria at screening
  • Meet criteria for mild-to-moderate cognitive impairment with Mini-Mental State Examination (MMSE) score of 14 through 26 at the screening visit.
  • Neuroimaging evidence consistent with the diagnosis of AD
  • Modified Hachinski </= 4 at screening
  • Clinical Dementia Rating is 0.5 to 2.0 at screening and Clinical Dementia Rating - Sum of Boxes is ≥ 3 at screening
  • Visual and auditory acuity adequate for neuropsychological testing
  • No evidence of hepatic impairment or renal insufficiency

Who cannot join

  • Have a current diagnosis of a significant psychiatric illness per the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V)
  • With untreated clinical depression (GDS >/= 6 at screening and baseline)
  • Have a current diagnosis of a neurological disease other than AD
  • With glycosylated hemoglobin (HbA1c) >/= 7.7 at screening
  • With a diagnosis of unstable diabetes
  • With clinically significant thyroid disease at screening TSH >5
Show all 29Show fewer
  • Have any of the following values at the screening visit:
  • ALT and/or AST value that is twice the upper limit of normal
  • Total bilirubin value that exceeds 2 mg/dL
  • Creatinine level >1.5 mg/dL in men or > 1.4 mg/dL in women
  • Positive urinalysis (other than trace result) unless a cause other than renal impairment
  • Glomerular filtration rate (GFR) values <54 mL/min/1.73 m2
  • Gamma-glutamyl transpeptidase (GGT) value that is twice the upper limit of normal
  • Is positive for hepatitis B or anti-hepatitis C virus antibodies at the screening
  • Have a history of moderate or severe congestive heart failure, NYHA class III or IV
  • Have experienced a previous cardiovascular event (myocardial infarct, by-pass surgery, or PTCA) within the past 12 months prior to the baseline
  • Have blood pressure reading at screening that is greater than 160/100 mmHg
  • Have a clinically significant unstable illness
  • Have a history of HIV infection
  • Have a history of alcohol, drug abuse or dependence
  • Have a history of cancer within 5 years of the screening
  • Have any surgical or medical condition which may significantly alter the absorption of any drug substance
  • Females who are pregnant, nursing or of childbearing potential and not practicing effective contraception
  • Is required to take excluded medications as specified protocol
  • Have a known or suspected intolerance or hypersensitivity to the study drug, closely related compounds
  • Resides in hospital or moderate to high dependency continuous care facility
  • Are non-ambulatory, or wheelchair-bound
  • Have evidence of clinically relevant pathology that in the investigator's opinion could interfere with the study results or put the subject's safety at risk
  • History of swallowing difficulties

Trial locations and contacts

1 site in 1 country.

United States1 site

  • T3D Therapeutics

    Durham, North Carolina, 27709

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

Study Design \& Methods: Phase 2 multi-center, randomized, double blind, placebo-controlled study of T3D959 15 mg, 30 mg, 45 mg, or matching placebo administered orally once daily for 24 weeks. There will be equal allocation of subject numbers across the four groups. Stratified randomization will be conducted on the basis of ApoE4 genotype so that subjects are randomized into one of the four dose groups within each stratum of ApoE4 status: ApoE4-positive (at least one E4 allele) vs ApoE4-negative (no E4 alleles).

Following informed consent, subjects will enter the screening phase of the study.

Once eligibility is confirmed and before the start of the first dose of study drug, subjects will be randomized on a 1:1:1:1 basis to placebo or T3D959 treatment (15mg, 30mg, 45mg) for the 24-week treatment period. Investigators, subjects, and caregivers will be blinded to the treatment assignment.

Study schedule visits: screening, baseline, weeks 4, 8, 16, 24 and 28 (F/U visit)

Being tested
15mg T3D-959, 30 mg T3D-959, 45 mg T3D-959, Placebos
Keywords
mild-to-moderate Alzheimer Disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 15mg T3D-959Drug

    Also called T3D-959

    Oral administration once daily in the morning

  • 30 mg T3D-959Drug

    Also called T3D-959

    Oral administration once daily in the morning

  • 45 mg T3D-959Drug

    Also called T3D-959

    Oral administration once daily in the morning

  • PlacebosDrug

    Also called T3D-959 Placebo

    Oral administration once daily in the morning

Study groups in NCT04251182
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo, 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.
Receives: Drug: Placebos
15mg T3D-959ExperimentalT3D-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.
Receives: Drug: 15mg T3D-959
30mg T3D-959ExperimentalT3D-959 30 mg dose: Subjects will ingest two size 0, 15mg capsules and one placebo capsule once per day in the morning.
Receives: Drug: 30 mg T3D-959
45mg T3D-959ExperimentalT3D-959 45 mg dose: Subjects will ingest three size 0, 15mg capsules once per day in the morning.
Receives: Drug: 45 mg T3D-959

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of T3D-959 on cognition

    Change in cognition as assessed by The Alzheimer's Disease Assessment Scale 11-task cognitive subscale (ADAS-Cog11) from baseline to end of treatment visit, compared to placebo

    Measured: 28 weeks (Subjects are on active treatment for 24 weeks followed by a 4-week follow-up)

  2. Efficacy of T3D-959 on function

    Change in global function as assessed by Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) from baseline to end of treatment visit, compared to placebo

    Measured: 28 weeks (Subjects are on active treatment for 24 weeks followed by a 4-week follow-up)

  3. Safety and tolerability of T3D-959

    Safety will be assessed by 1) AEs, clinical labs, ECG, weight, vital signs 2) Geriatric Depression Scale (GDS) 3)Columbia Suicide Severity Rating Scale (C-SSRS)

    Measured: 28 weeks (Subjects are on active treatment for 24 weeks followed by a 4-week follow-up)

Secondary outcomes (2)

  1. Efficacy of T3D-959 on executive function

    Change in executive function as assessed by the Digit Symbol Coding Test (DSCT) from baseline to end of treatment visit, compared to placebo

    Measured: 28 weeks (Subjects are on active treatment for 24 weeks followed by a 4-week follow-up)

  2. Efficacy of T3D-959 on plasma Aβ 42/40 ratio biomarker level

    Change in Aβ 42/40 ratio plasma biomarker from baseline to end of treatment visit, compared to placebo

    Measured: 28 weeks (Subjects are on active treatment for 24 weeks followed by a 4-week follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2020
  2. Study start1 Mar 2021
  3. Primary completion20 Jan 2023
  4. Study completion17 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized, double-blind, placebo-controlled design evaluating three dose levels (15 mg, 30 mg, 45 mg) of T3D-959 in subjects with mild-to-moderate Alzheimer's Disease. Subjects will be stratified by ApoE4 genotype and assigned to one of four dose groups (1:1:1:1 ratio) in a randomized fashion.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04251182
Sponsor's protocol ID
T3D959-202
Other IDs
1R01AG061122
Status last verified
Jul 2024
First submitted
24 Jan 2020
Last updated
19 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: A Clinical Study Report (CSR) will be generated within 9 months after database lock. Aggregate study data will be made available in this report.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 15mg T3D-959, 30 mg T3D-959 and 45 mg T3D-959 in people with Alzheimer Disease, run by T3D Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of T3D-959 on cognition (time frame: 28 weeks (Subjects are on active treatment for 24 weeks followed by a 4-week follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04251182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.

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