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

  • STATUS
    Recruiting
  • End date
    Jul 25, 2022
  • participants needed
    256
  • sponsor
    T3D Therapeutics, Inc.
Updated on 26 September 2021
Investigator
Director, Clinical Development
Primary Contact
Suncoast Clinical Research (4.7 mi away) Contact
+62 other location
cognitive impairment
dementia
mini-mental state examination
mental state examination
neuropsychological test

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.

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)

Details
Condition Dementia, Alzheimer's Disease, alzheimer, dementia alzheimer's type, Alzheimer Disease
Treatment placebos, 15mg T3D-959, 30 mg T3D-959, 45 mg T3D-959
Clinical Study IdentifierNCT04251182
SponsorT3D Therapeutics, Inc.
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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 <60 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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