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Trial to Test Drug to Delay Early-Onset Alzheimer’s

Brain scan (National Institute of Mental Health)

(National Institute of Mental Health)

28 January 2015. A clinical trial is planned to test a current drug for epilepsy as a way to delay the early onset of Alzheimer’s disease. The late-stage trial undertaken by AgeneBio Inc., a start-up pharmaceutical company in Baltimore, is funded by a $900,000 grant from Alzheimer’s Drug Discovery Foundation.

The trial aims to address amnestic mild cognitive impairment, considered an indicator and predictor of Alzheimer’s disease. The condition is marked by memory, language, and judgement difficulties greater than expected age-related problems, but not reaching the severity of dementia. AgeneBio says about 5.6 million people in the U.S. and 25 million worldwide have amnestic mild cognitive impairment.

The company cites data from National Institute on Aging showing even modest delays in the onset of Alzheimer’s disease can return sizable benefits to individuals, as well as their families and communities. For each one-year delay in the onset of Alzheimer’s disease, says AgeneBio, there’s a 10 percent reduction in the prevalence of the disorder.

The study is testing a low-dose form of the drug levetiracetam, originally developed to treat certain seizures associated with epilepsy, by decreasing abnormal excitement in the brain. AgeneBio devised this formulation, code-named AGB101, at about 1/15th the regular dose of levetiracetam for epilepsy, to reduce hyperactivity in the hippocampus, the part of the brain associated with memory. Overactivity in the hippocampus is believed to disrupt normal memory functions, beginning in the entorhinal cortex, considered the gateway for making memories.

Because levetiracetam has been on the market for more than a decade — marketed by UCB Pharmaceuticals as Keppra and in generic form — it is well-tolerated and has a known safety profile. The trial is scheduled to start in the second half of 2015 and continue to 2018.

AgeneBio is commercializing research by its founder Michela Gallagher, a professor of psychology and neuroscience at Johns Hopkins University in Baltimore, whose research includes the neurobiological basis of cognitive impairment in the aging process. Gallagher serves as the company’s chief scientist.

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