A Trial of LMTM in Patients with Alzheimer's Disease (TRx-237-015)
Research type
Research Study
Full title
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-Month Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Mild to Moderate Alzheimer's Disease
IRAS ID
114243
Contact name
Mark Dale
Contact email
Sponsor organisation
TauRx Therapeutics Ltd
Eudract number
2012-002866-11
Research summary
Alzheimer's disease is the most common form of dementia for which there is no cure which worsens as it progresses eventually leading to death. Treatments commonly used to treat this illness, only predominantly address certain aspects, but do not directly affect the core pathology of the disease. As there is a need to develop new medications for this disease, the investigational product for this trial (TRx0237), is believed to have the potential to offer benefits over current treatments. This study is designed as a double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety and tolerability of TRx0237 daily to patients with mild to moderate Alzheimer??s disease. Placebo tablets in the placebo group will include 4 mg LMTM as a urinary and faecal colorant to maintain blinding. In addition, all patients will receive two blank tablets of different size per day to maintain the blind. Eligible patients will be randomised at the baseline visit to one of the following three treatment groups: TRx0237 150 mg/day, TRx0237 250 mg/day or the placebo group. Patients enrolled into this study will have a diagnosis according to the National Institute on Aging / Alzheimer??s Association criteria of all cause dementia and probable Alzheimer??s disease. The allowable severity of AD will be mild to moderate, as indicated by a Mini-Mental Status Examination (MMSE) score of 14 to 26. The total duration of participation for an individual patient will be approximately 60 weeks, including a screening period of up to 28 days, a double-blind treatment period of 52 weeks, and a post-treatment assessment 4 weeks following completion of randomised treatment. Additional follow-up visits may be scheduled as needed to monitor the resolution or stabilisation of adverse effects. It is anticipated that the study will have an overall duration of approximately 26 months.
REC name
North West - Haydock Research Ethics Committee
REC reference
12/NW/0711
Date of REC Opinion
23 Jan 2013
REC opinion
Further Information Favourable Opinion