Open-label extension study of LMTM in Alzheimers & bvFTD patients
Research type
Research Study
Full title
An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia
IRAS ID
159477
Contact name
Lawrence Wong
Contact email
Sponsor organisation
TauRx Therapeutics Ltd
Eudract number
2014-002013-37
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.
Behavioral variant frontotemporal dementia (bvFTD) is a rare, progressive neurodegenerative disease characterized by progressive deterioration of behavior and language, associated with atrophy of the frontal and temporal lobes. It typically occurs sometime in the 50s, though it can occur as early as age 20 or as late as age 80. There are currently no licensed treatments for any form of FTD.
As there is a need to develop new medications for these diseases, the investigational product for this trial (TRx0237), is believed to have the potential to offer benefits over current treatments.
There are currently a few studies ongoing to assess the efficacy, safety and
tolerability of TRx0237 and this study is an open-label extension to provide subjects who have completed participation in a Phase 2 or Phase 3 trial continued access to therapy and to evaluate the long-term safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with AD or a rare form of dementia (Behavioral Variant Frontotemporal Dementia).Appropriateness of continued treatment will be re-evaluated every 12 months on the basis of benefit and safety/tolerability; informed consent must be obtained for each subsequent extension. A 4-week post-treatment follow-up visit will be scheduled for all subjects if they discontinue prematurely or do not re-enroll for a subsequent extension phase. The study will continue until alternate options for access to treatment are available, i.e., commercialization or, depending on country, on a Named Patient or compassionate basis or via a Managed Access Program.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/1153
Date of REC Opinion
4 Sep 2014
REC opinion
Favourable Opinion