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Diabetes Drug Pioglitazone May Lower Risk of Alzheimer’s Disease

Data presented at Alzheimer’s conference

According to a report from Reuters, a new German study has suggested that treatment with the diabetes drug pioglitazone (Actos, Takeda; generics) may reduce the risk of developing Alzheimer's disease (AD), although conclusive proof could be years away.

The findings were presented July 14 at the Alzheimer's Association International Conference in Copenhagen.

Using data from German health care plans for 2004 to 2010, researchers tracked 146,000 subjects 60 years of age and older who did not have evidence of dementia at baseline. A total of 13,841 subjects (9.5%) eventually developed dementia. Among those taking pioglitazone, the risk of dementia was significantly reduced with each additional 3 months the drug was prescribed.

Dr. Anne Fink, a researcher at the German Center for Neurodegenerative Diseases in Bonn, speculated that pioglitazone helped prevent AD by reducing inflammation in the brain and nervous system. Last year, Takeda Pharmaceutical Company initiated a 5-year study to determine whether low doses of pioglitazone could delay the onset of mild cognitive impairment (MCI) caused by AD.

The phase III TOMMORROW trial is a global, randomized, double-blind, placebo-controlled, parallel-group trial. The study will use a genetic-based biomarker risk-assignment algorithm to determine the risk of individuals developing MCI due to AD within a 5-year period. The trial is enrolling approximately 5,800 cognitively normal subjects aged 65 to 83 years who have genetic variations known to increase the risk of early-onset AD.

Individuals assessed as low-risk will be assigned to receive placebo. Individuals assessed as high-risk will be assigned to receive low-dose pioglitazone or placebo.

The study’s primary objective is to evaluate the efficacy of low-dose pioglitazone compared with that of placebo in delaying the onset of MCI due to AD in cognitively normal individuals assessed as high-risk based on the risk assignment algorithm. The primary endpoint is the time to diagnosis of MCI due to AD for pioglitazone-treated subjects versus placebo-treated subjects in the high-risk stratum. Key secondary objectives include the effects of low-dose pioglitazone compared with placebo on the progression of cognitive decline and the effects of pioglitazone versus placebo on functional decline and instrumental activities of daily living. Pioglitazone is considered an investigational agent for these uses.

According to Reuters, previous studies in patients with type-2 diabetes have shown that those with poor blood sugar control were more likely to develop dementia. Moreover, patients taking thiazolidinediones, such as pioglitazone, had about a 20% lower risk of developing AD compared with those treated with insulin.

Sources: Reuters; July 14, 2014; and Takeda; August 26, 2014.

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