A Trial of LMTM in Patients Taking Medication for AD (TRx-237-008)
Research type
Research Study
Full title
A Double-Blind, Placebo-Controlled, Randomised, 4-Week Safety and Tolerability Study of LMTM in Subjects with Mild to Moderate Alzheimer’s Disease on Pre-Existing Stable Acetylcholinesterase Inhibitor and/or Memantine Therapy
IRAS ID
96766
Contact name
Mark Dale
Contact email
Sponsor organisation
TauRx Therapeutics Ltd
Eudract number
2011-005292-17
ISRCTN Number
0
Clinicaltrials.gov Identifier
0
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 being performed in patients with mild to moderate Alzheimer??s disease to assess the safety and tolerability of TRx0237. This study is designed as a double-blind, placebo-controlled Phase 2 study to assess the safety and tolerability of TRx0237 daily when co-administered with an acetylcholinesterase inhibitor (AChEI) and/or memantine to patients with mild to moderate Alzheimer??s disease. Placebo tablets will include 4 mg LMTM as a urinary and faecal colorant to maintain blinding. Eligible patients will receive at the baseline visit to one of the following two treatment groups: the TRx0237 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 12 weeks, including a screening period of up to 28 days, a double-blind treatment period of 4 weeks, and a post-treatment assessment 14 to 28 days 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 6 months.
REC name
North West - Haydock Research Ethics Committee
REC reference
12/NW/0441
Date of REC Opinion
31 Jul 2012
REC opinion
Further Information Favourable Opinion