New Delhi: A drug has shown “marked beneficial" effects on patients with Alzheimer’s disease in a large-scale phase 3 clinical trial, scientists announced at the Alzheimer’s Association International Conference (AAIC) in Toronto on Wednesday.

The drug showed significant reduction in the rate of progression of the disease, but only in patients using it, and no other, as their Alzheimer’s medication.

TauRx Therapeutics Ltd carried out a study of its drug LMTX on 891 subjects. Called TRx-237-015, the study was a randomised double-blind placebo-controlled study in subjects with mild or moderate Alzheimer’s disease. It compared treatment for 15 months with LMTX and a placebo.

“In a study of this size, across a combined mild to moderate patient population, it is both encouraging to see improvements of this magnitude in the standard cognitive and functional tests and reassuring to see the supporting brain scan evidence of a slowing in disease progression during 15 months of treatment," said Serge Gauthier, director of the Alzheimer’s Disease Research Unit in Canada-based McGill University.

“In a field that has been plagued by consistent failures of novel drug candidates in late-stage clinical trials and where there has been no practical therapeutic advance for over a decade, I am excited about the promise of LMTX as a potential new treatment option for these patients," Gauthier said, while presenting the findings at the Toronto conference.

This is the first treatment in which a clinical effect has been supported by evidence of delay in progression of brain atrophy, as shown by MRI scans, Singapore-based TauRx Therapeutics said in a press release.

Since patients taking other standard medication comprised a majority of trial patients, the treatment benefits seen in those taking LMTX as their only medication could not be seen when all patients taking LMTX were taken into account in the primary analysis model.

When taken as the only therapy, the drug slowed down the rate of progression of brain atrophy or loss of neurons by up to 38% when measured on MRI scans.

TauRx’s tau aggregation inhibitors have been developed from nearly 30 years of research. These focus on the tau tangles that cause dementia, hence slowing and even pausing memory loss.

“The results we have seen in this study confirm the results we saw in our Phase 2 study, where an earlier version of the drug was also given as monotherapy. The results we see in those patients not taking Alzheimer’s disease medications show the considerable potential of LMTX as a monotherapy for both mild and moderate Alzheimer’s disease," said Claude Wischik, professor of Psychiatric Geratology at Aberdeen University and co-founder of TauRx.

Wischik highlighted that these results support that targeting the tau tangle will prove to be an important area of drug research for the disease. “However, the reason for the observed loss of efficacy of LMTX when taken in combination with currently available treatments for Alzheimer’s disease is not as yet understood," he added.

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