How T3D-959 works
According to some researchers, Alzheimer’s disease is a metabolic disease caused by age-related metabolic dysfunctions.
It is hoped that by acting on the PPAR proteins, T3D-959 may correct these metabolic dysfunctions and ease the symptoms of the disease.
T3D-959 in clinical trials
Initial human safety data has not been published but was presented at a conference and is listed on the company’s website. 96 healthy participants were administered ascending doses up to 200 mg over 7 days with no adverse events and no maximum tolerated dose (the dosage at which side effects are no longer acceptable) reached.
Based on the promising preclinical and safety results, a Phase 1/2 open-label feasibility study (NCT02560753) of T3D-959 in 36 people with mild-to-moderate Alzheimer’s disease was conducted. Participants were randomly assigned to varying doses of T3D-959 administered by mouth once a day for 14 days. The primary endpoints were the change in cerebral metabolic rate for glucose (sugar) and oxygen in the regions of the brain typically affected by Alzheimer’s disease. Changes in these two parameters were observed through positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). Secondary endpoints included changes from baseline in cognitive test scores.
Preliminary results were revealed by the company in a presentation at the 2016 Alzheimer’s Association International Conference. They showed that T3D-959 led to rapid improvement in cognitive tests in more than half (53 percent) of all the participants (a total of 36) with mild-to-moderate Alzheimer’s disease.
Final results of the trial were published on the clinical trial website and also presented at the 2016 Clinical Trials in Alzheimer’s Disease Conference, the 2018 Annual American Society for Experimental Neurotherapeutics, and the 2018 Alzheimer’s Association International Conference. The results showed that the drug was safe and well-tolerated at each of the different dosages. The trial results also showed the potential efficacy for cognitive improvements and changes in brain glucose metabolism.
T3D Therapeutics is planning another Phase 2 trial called PIONEER to begin dosing patients in early 2020. T3D recently received a $9 million grant from the US National Institute of Aging (NAI) to help fund the phase 2 trial. The trial is planning to enroll up to 252 patients with mild to moderate Alzheimer’s who will receive one of three doses of T3D-959 or a placebo for 24 weeks.
Last updated: Sept. 4, 2019
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