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Trial Shows Current Drug Slows Alzheimer’s Onset

Michela Gallagher

Michela Gallagher (Johns Hopkins University)

11 March 2015. A clinical trial testing a current drug to treat epilepsy shows the drug can delay development of Alzheimer’s disease in its earliest stages. Results of the study, conducted by researchers at Johns Hopkins University for AgeneBio Inc., two year-old pharmaceutical company in Baltimore, appear online in the journal NeuroImage: Clinical.

The intermediate-stage trial tested a low-dose form of the druglevetiracetam, originally developed to treat certain seizures associated with epilepsy, by decreasing abnormal excitement in the brain. AgeneBio is testing its low-dose formulation, code-named AGB101, to amnestic mild cognitive impairment, considered an indicator and predictor of Alzheimer’s disease. 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.

Amnestic mild cognitive impairment 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 this condition.

The trial was led by AgeneBio’s 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. AGB101 sharply reduces the normal dose of levetiracetam prescribed for epilepsy, designed 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.

The study evaluated 69 patients with amnestic mild cognitive impairment, with 54 randomly assigned to receive AGB101 once a day at 1 of 3 dosage levels and 17 receiving a placebo. Participants’ cognitive functions were assessed on several tests and indexes, including mental status, selective memory, paired associations, visual retention, and basic activities of daily living. The trial also tested participants’ hippocampus activity, using functional MRI that provides images of neural activity in the brain. These assessments were made before administering AGB101 or the placebo, then at 2, 6, and 8 weeks following the first baseline measures.

The findings show patients receiving AGB101 at all dosage levels scoring higher on the memory tests than participants receiving the placebo. Likewise, patients receiving AGB101 show reduced hippocampus activity to normal ranges compared to the placebo group. The researchers found no differences between the two highest dosages — 125 and 250 milligrams — of AGB101 on either the memory tests or hippocampus activity results.

In January, AgeneBio received funding from Alzheimer’s Drug Discovery Foundation to conduct a phase 3 or late-stage clinical trial with larger numbers of patients. That trial is expected to start in the second half of 2015 and continue to 2018.

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