Alzheimer’s drug shows promise for patients in phase III trial

At the Alzheimer’s Association International Conference 2016 (AAIC 2016), held in Toronto, Canada, researchers reveal how a drug called LMTX shows promise for halting the formation of tau tangles.

Alzheimer’s disease is estimated to affect 5.4 million people in the United States, and by 2050, it is expected to affect around 13.8 million Americans, unless new treatments are identified that tackle the disease at its roots.

For years, scientists have worked to find ways to combat the two prime suspects for Alzheimer’s development: tau tangles and amyloid plaques – clumps of beta-amyloid protein, which are believed to disrupt nerve cell communication.

 Medical News Today have reported on some interesting developments in this field; a study earlier this month, for example, revealed the creation of a vaccine that researchers say could halt the formation of tangles and plaques.

 While an undoubtedly exciting development, it will still be another 3-5 years before this vaccine can be tested in humans, and this long road to human trials been the case for the vast majority of Alzheimer’s studies – until now.

 Dr. Serge Gauthier – of the Departments of Neurology & Neurosurgery, Psychiatry, and Medicine at McGill University in Canada – and colleagues have completed the first ever phase III trial of a drug that targets the tau protein, and the drug in question – LMTX – proved beneficial for a small subgroup of patients.

 According to the researchers, LMTX – developed by TauRx Pharmaceuticals – is a tau aggregation inhibitor (TAI), meaning it targets the tau protein in the brain and prevents it from forming tangles that contribute to Alzheimer’s disease.

 For their phase III trial, Dr. Gauthier and colleagues enrolled 891 patients of an average age of 70.6 years who had mild or moderate Alzheimer’s disease. Subjects were recruited from 115 sites over 16 countries across Asia, Europe, North America, and Russia.

 Participants were randomized to receive one of three treatments for 15 months: oral LMTX at a dose of 150 milligrams daily, oral LMTX at a dose of 250 milligrams daily, or a control dose of 8 milligrams of LMTX daily – the placebo – in order to maintain blinding to treatment.

 Around 85 percent of subjects were also using other forms of approved treatment for Alzheimer’s, the team reports.

 At study baseline and every 13 weeks thereafter, subjects underwent brain imaging and standard tests of cognitive functioning and day-to-day functioning, including the Alzheimer’s Disease Assessment Scale cognitive subscale (ADAS-Cog) and Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).

 Results of LMTX efficacy and safety were assessed as a whole and by disease severity, region, and the use of other Alzheimer’s treatments.

 Across the full study population, LMTX at both doses was found to have no benefit for cognitive functioning, daily functioning, or brain atrophy – the loss of nerve cells – compared with the placebo.