T817MAEU201
Research type
Research Study
Full title
A Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of T 817MA in patients with mild cognitive impairment due to Alzheimer’s Disease or mild Alzheimer’s Disease.
IRAS ID
257933
Contact name
Richard Perry
Contact email
Sponsor organisation
FUJIFILM Toyama Chemical Co., Ltd.
Eudract number
2018-003567-66
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Research Summary
Alzheimer's Disease (AD) is a progressive, incurable disease. It is characterized by degeneration of large portions of the brains, resulting in a progressive decline in cognitive functions and behavior with the typical symptoms of memory loss in patients. The therapeutic options for AD are limited and only reduce the symptoms. There is a need for treatments that address the underlying pathological process of the disease.
T-817MA is a low molecular weight compound, which shows neuroprotection and preservation of neural network by acting on both neurons and glial cells. In the previous phase 2 study targeting mild to moderate AD patients, dose-dependent decreases in both p-tau and total tau in CSF were observed and the differences between 448 mg of T-817MA and placebo were statistically significant. The data may suggest a neuroprotective effect of T-817MA against tau-related AD pathology. T-817MA may show benefit by modifying pathology of tau-related diseases (tauopathies) such as mild cognitive impairment (MCI) due to AD or early AD, because tau-related pathological changes of AD are known to precede memory and functional impairment.
This study is a proof of concept study to investigate the neuroprotective effect of T-817MA in patients with MCI due to AD or mild AD based on p-tau as the primary endpoint. The efficacy and safety of T-817MA in patients with MCI due to AD or mild AD will be evaluated.Summary of Results
T817MAEU201 was a well-controlled study, well balanced at baseline and excellent retention. Treatment of 448 mg of T-817MA appeared to be safe and tolerable. No changes in CSF p-tau 181 were observed as a result of the intervention vs placebo.
REC name
West of Scotland REC 1
REC reference
19/WS/0015
Date of REC Opinion
4 Jul 2019
REC opinion
Further Information Favourable Opinion