A Phase 2b/3 Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Evaluate the Safety and Efficacy of T3D-959 in Subjects With Mild-to-Moderate Alzheimer's Disease
T3D Therapeutics, Inc.
Summary
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.
Description
This study is a randomized, double-blind, placebo-controlled study of T3D-959 30mg in subjects with clinical mild-to-moderate Alzheimer's Disease and a biological diagnosis of AD pathology, as defined by a validated plasma biomarker (presently %p-tau217 plasma biomarker). This study is designed as a seamless group sequential design where estimates of treatment effect on cognitive and functional scales will be evaluated in an interim analysis by independent statisticians. The sample size will be re-estimated to ensure the study is sufficiently powered to demonstrate efficacy of T3D-959 in cogni…
Eligibility
- Age range
- 50–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female subject aged 50-90 years old inclusive at the time of Informed Consent 2. Subject (or legal representative) and caregiver must sign an Informed Consent to participate in the study. 3. Subject has a caregiver, an identified adult who, in the opinion of the investigator, has sufficient contact to knowledgeably report on the subject's cognition, function, behavior, safety, compliance and adherence. Same caregiver should, whenever possible, assist the subject throughout the duration of the trial 4. Subject has a biological diagnosis of AD pathology, as assess…
Interventions
- DrugT3D-959
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 capsules contain 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.
- OtherPlacebo Comparator
Placebo used to compare to T3D-959 drug
Location
- T3D Therapeutics, Inc.Durham, North Carolina