A Promising New Clinical Trial in the Treatment of Alzheimer's

[ABSTRACT]

IMAGE CREDIT: Biogen

The goal of Alzheimer’s research is to find a treatment that slows, stops or reverses the progression of the disease. Last Friday, Biogen Idec - as of this morning now Biogen - reported the results of preliminary studies that suggest that such a treatment may be in the works.

The drug, called aducanumab, has just finished its Phase 1 clinical trial, the phase which tests the drug’s safety and appropriate dosage. There were 166 subjects in this trial who had been diagnosed with mild Alzheimer’s disease or who had amyloid plaque build up without symptoms. The subjects were divided into roughly 5 groups. One group received a placebo. The other four groups received doses of 1 mg, 3 mg, 6 mg or 10 mg, respectively, for a period of 54 weeks. (Those taking the 6 mg dosage have not yet completed the 54 week course, and their data are still be collected.)

All subjects underwent PET scans to map amyloid build up at the start of the study, and they were repeated mid-way and again at the completion of the study. The subjects also took a battery of tests that measured cognition and functionality at base line and at the study’s completion.

The Good News

Researchers are encouraged by the fact that the PET scans showed that those who received the drug had statistically significant reductions in the amount of amyloid in their brains. Further, their cognitive and functional decline was less than those who received the placebo. These improvements were linked to the dosage that they received: those who received the highest doses of the drug had the most amyloid reduction and experienced the least cognitive decline. The fact that the responses were dose-related strongly suggests that these changes are directly related to the drug itself.

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