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Tau-Based Alzheimer's Disease Therapy Appears to Arrest Disease Progression, Improve Cognition in Phase 2

Caroline Cassels,
August 1, 2008 (Chicago, Illinois) New research suggests that a treatment that targets neurofibrillary tangles arrests disease progression and improves cognitive function in patients with mild-to-moderate Alzheimer's disease (AD).

According to investigators, the results of the randomized, double-blind, placebo-controlled phase 2b study of methylthioninium chloride (MTC, Rember), a tau-aggregation inhibitor, mark the first time a tau-based therapy has been shown to have a disease-modifying effect on AD.

"The data from this study strongly suggest that this kind of treatment could halt disease progression at an early Braak stage. In other words, when the pathology is just beginning to kill neurons," said principal investigator Claude Wischik, MB ChB, from Aberdeen University, United Kingdom, and chairman of TauRx Therapeutics that developed the drug.

The phase 2 study, presented for the first time here at ICAD 2008: Alzheimer's Association International Conference on Alzheimer's Disease, involved 321 patients with mild-to-moderate AD from 17 centers in Singapore and the United Kingdom.

The primary objective of the 24-week trial was to compare the effects of oral MTC (at 30, 60, and 100 mg, 3 times per day) and placebo on cognitive function, measured using the Alzheimer's disease assessment scale-cognition (ADAS-cog). This was followed by a 60-week blinded active-treatment extension of the trial.

Among the secondary outcomes were the safety and tolerability of the drug, and the effect of MTC on a range of scales, including the Mini-Mental State Examination (MMSE), the Clinical Dementia Rating scale, sum of boxes (CDRsb), the Clinical Global Impression of Change (CGIC), the Alzheimer's Disease Functional Assessment and Change Scale (ADFACS), and the Neuropsychiatric Inventory (NPI).

But most important, said Dr. Wischik, the investigators were interested in examining the drug's disease-modifying potential.

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