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news.The Roskamp Institute has reported that its new drug application for the treatment of Alzheimer's disease has received positive validation from an independent human clinical study conducted at the Tokyo Medical University in Japan.
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The Japanese study was conducted over the course of a 20-month period, where a group of 15 amnestic mild cognitive impairment (MCI) patients with essential hypertension were divided into two groups. A group of eight participants were randomly allocated to take the drug, nilvadipine, while the other seven remaining participants were designated to take the drug, amlodipine.
The study found that the group treated with nilvadipine had stabilized their decline in memory over the 20 months; whereas, the group treated with Amlodipine had continued to suffer loss of cognitive function, which was double that of the small decline in the nilvadipine controlled group.
The Roskamp Institute plans to introduce nilvadipine to the FDA as a part of its Phase II study early next year.
Michael Mullan, director of the Roskamp Institute, said: “Although the study was conducted with a small sample size, this third- party validation is extremely encouraging, as there appears to be a strong protective effect from developing Alzheimer’s in memory-troubled patients who were given nilvadipine.”