Sarasota, Fla.— New data from a clinical trial of Alzheimer’s Disease using a drug called Nilvadipine identified by researchers at the Roskamp Institute show that patients with very mild (very early stage) Alzheimer’s disease show less cognitive decline over an 18-month period than placebo-treated patients. On the key clinical measure of memory, the very early stage Alzheimer cases who were taking Nilvadipine performed better than their placebo-treated counterparts. For patients with mild Alzheimer’s (a slightly more advanced stage), the use of language was better preserved after Nilvadipine treatment. In overall measures of mental ability in very early stage patients, compared to placebo, there was a nearly 50 percent reduction in the rate of decline in those taking Nilvadipine, which has been previously used to treat hypertension in many European countries and Japan, though not approved in the United States. The new analysis was a follow up of data collected by a European network of collaborators with the Roskamp Institute scientists in a study called NILVAD and headed by Dr. Brian Lawlor at Trinity College Dublin.
In other studies, the Roskamp Institute’s researchers have shown that Nilvadipine can lower the levels of two toxic proteins (called amyloid and tau) in the brains of mice that spontaneously develop Alzheimer pathology. Importantly, these findings are consistent with those in the human clinical trial where examination of cerebrospinal fluid samples from Alzheimer patients suggested that the improved mental functioning was associated with increased release of toxic amyloid out of the brain.
However, scientists strongly cautioned that the study also showed that the drug was not helpful, and may have even increased cognitive decline, in individuals who began the treatment much later in the disease process. “Understanding how this drug may be beneficial in very early stage patients is obviously important for further development of new treatments for Alzheimer’s Disease,” says Dr. Michael Mullan, Executive Director of the Roskamp Institute. The Institute’s scientists have been awarded National Institutes of Health funding to develop second-generation drugs designed to replicate the
potential beneficial effects of Nilvadipine without some of the unwanted side effects such as unnecessary lowering of blood pressure. Dr. Mullan added, “the development of drugs for Alzheimer’s Disease has been fraught with multiple late-stage clinical failures, but one area of consensus which has emerged is that for effectiveness of many experimental drugs the treatment must start very early in the disease process. I believe we are seeing the same effect with this treatment, and we must endeavor to increase both the potency and early use of such medicines.”
Dr. Rudolph Tanzi, a Professor of Neurology at Harvard Medical School who is familiar with the results commented, “The possibility that Nilvadipine may impact the three main pathologies of Alzheimer’s disease (amyloid, tau and neuroinflammation) makes it potentially very useful among current therapies. While more trials are needed, the hope is this drug will ultimately be effective for both presymptomatic prevention and treating early-stage patients.”
The results are published today in the scientific journal Frontiers in Neurology.
More than 5.7 million Americans are living with Alzheimer’s Disease—which is the 6th leading cause of death, according to the Alzheimer’s Association—and is the most expensive disease in the country, costing $21 million per hour. The study took place over 18 months in nine European countries and was largely funded by the European Commission.
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