This multi-centre, placebo-controlled clinical trial (Protocol TRx-237-005) is aimed at assessing the efficacy of LMTX in people diagnosed with mild Alzheimer’s disease. The study is also evaluating the safety and pharmacokinetic profile of LMTX, and incorporates imaging endpoints in all subjects.
In July, TauRx announced that the Company had achieved its target enrolment of 833 subjects into its first Phase III clinical trial (Protocol TRx-237-015); this study recruited subjects with mild and moderate Alzheimer’s disease. The third global study, TauRx’s Phase III clinical trial (Protocol TRx-237-007) in patients with behavioural variant frontotemporal dementia (bvFTD), continues to recruit subjects, and is on track to complete enrolment by early 2015.
Professor Claude Wischik , Chairman and co-founder of TauRx, said "Reaching our enrolment targets for both of our Phase III Alzheimer’s disease clinical trials is a major milestone for our Company and it is particularly apt that we can announce this on World Alzheimer’s Day. This achievement brings us another step closer to our objective to offer the first tau-targeted disease-modifying treatment for Alzheimer’s disease – an important treatment advance for patients."
He added "Having recently participated in the G8 Dementia Summit legacy meetings, I am acutely aware of the call from governments, physicians, carers, patients and international Alzheimer’s groups for innovative treatments to slow or stop the inevitable cognitive decline to dementia. With both of our studies now set for completion in 2016, TauRx may be in the unique position of turning this hope into practical reality in the very near future."
Professor Wischik attributed the completion of enrolment into the clinical trials to the support of more than 100 global clinical research centres and dedicated physician investigators, a motivated TauRx project team lead by Dr. Jiri Hardlund as well as the contributions of its partner companies.
He singled out two partner companies for their efforts in achieving enrolment targets: Worldwide Clinical Trials, a global Clinical Research Organisation that is managing the studies on behalf of TauRx, and MediciGroup, Inc. [dba MediciGlobal Ltd] a specialty patient recruitment firm that brings innovative approaches to accelerate global patient recruitment and retention for clinical trials.
With both clinical trials in Alzheimer’s disease now fully recruited, TauRx and its partners are turning their attention towards the bvFTD clinical trial. "LMTX™ has potential for the treatment of bvFTD because it targets aggregations of both the tau and TDP-43 proteins, which each account for about half of the cases," Wischik said. "Patients and families living with bvFTD are encouraged to contact the nearest research centre to be included in this Phase III clinical trial before the window of opportunity closes shortly," he added.
Interested people and families living with bvFTD are encouraged to visit www.taurx.com or www.FTDGlobalStudy.com to find a clinical research centre in their area, and to see if they meet the medical criteria for the TRx-237-007 trial for behavioural variant frontotemporal dementia-[bvFTD].
About the TRx-237-015 clinical trial for mild to moderate Alzheimer’s
This Phase III double-blind, placebo-controlled trial (TRx-237-015) is designed to assess the safety and efficacy of LMTX in patients diagnosed with mild to moderate Alzheimer’s disease. The treatment period is 15 months. The main measures are the change in study subjects’ cognitive performance at the beginning and the end of the study in three commonly used clinical assessments: The Alzheimer’s Disease Assessment Scale – Cognitive Subscale (known as ADAS-cog11); the Modified Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (known as ADCS-CGIC) and the Alzheimer’s Disease Cooperative Study – Activities of Daily Living scale (known as ADCS-ADL).
About the TRx-237-005 Phase III clinical trial for mild Alzheimer’s
This Phase III double-blind, placebo-controlled clinical trial is designed to assess the safety and efficacy of LMTX in up to 700 patients diagnosed with mild Alzheimer’s. The study involves approximately 100 clinical sites primarily in the U.S. and Europe . The clinical efficacy measures are the same as the TRx-237-015 trial. In addition reduction in decline in glucose uptake in the temporal lobe is being measured by FDG/PET imaging and reduction in the rate of brain shrinkage shown by MRI.
About the TRx-237-007 clinical trial for mild Alzheimer’s
This Phase III double-blind placebo-controlled study is designed to evaluate the safety and efficacy of LMTX in patients diagnosed with behavioural variant Frontotemporal Dementia (bvFTD). The treatment period is 12 months. The study is planned to involve 180 patients and ~70 study sites located in Canada , U.S., U.K., Germany , The Netherlands , Australia and Singapore . The main measures of efficacy are the change in study subjects’ performance at the beginning and the end of the study in two commonly used clinical assessments: (1) the Addenbrookes’s Cognitive Examination (Revised), known as ACE-R; and (2) the Modified Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change, known as ADCS-CGIC.