By Michael Mullan, M.D., Ph.D.
Herald-Tribune
In the global fight against Alzheimer’s disease, Sarasota’s Roskamp Institute stands on the front line. As academic centers around the world study ways to prevent the onset of this degenerative disease or ease the symptoms, our research team has developed a new drug with the potential to modify the course of this devastating condition.
In February, a collaborative, nine-country European research team launched a large-scale phase III clinical trial to evaluate the effectiveness of Nilvadipine in more than 500 Alzheimer’s patients. To put this into context, there are only eight phase III clinical trials under way worldwide; it is usually the last step in the regulatory process before a drug can move into clinical practice. It’s a tremendous achievement for a small research institute like ours to be part of the scientific effort to overcome this disease.
In our studies of neurodegenerative disorders, the Roskamp Institute team discovered that Nilvadipine, a drug approved in Europe for treatment of hypertension, can stop the accumulation of the toxic amyloid protein in the brain — a process implicated in Alzheimer’s disease by members of the Roskamp Institute team 20 years ago. In 2010, our institute completed a phase I/II clinical trial in Europe that focused on Nilvadipine’s safety. The results indicated that patients were able to tolerate the drug safely and appeared to benefit from treatment.
Now, we are looking forward to results from the next step: the multi-center phase III clinical trial organized by a consortium of medical teams from nine European countries.
The consortium, called NILVAD (Nilvadipine/Alzheimer’s Disease), will involve participants from Ireland, England, Hungary, Greece, France, Sweden, Germany, Italy and the Netherlands. Patients with mild to moderate cognitive deficits will be followed for an 18-month period to see if the medication can cut the progression of the disease in half.
Other important Alzheimer’s research is under way in academic centers in Europe and the United States, where finding ways to prevent or mitigate the disease has become a national health priority.
An estimated 5.4 million Americans have Alzheimer’s disease or similar dementias, and the number of cases is growing as the population ages. In January, President Obama set a goal of developing effective ways to treat and prevent Alzheimer’s disease by 2025 and launched the National Alzheimer’s Plan.
We are also learning much about the prevention of Alzheimer’s Disease. We now know that the tight medical control of hypertension, diabetes and cardiac disease can reduce our risk of the disease.
And although we don’t yet know the perfect diet to offset the disease it’s becoming clear that a diet rich in certain unsaturated fats, naturally occurring compounds like resveratrol (derived from red wine) and perhaps others derived from green tea may be beneficial in slowing the disease.
We know also that exercise is a critical part of the prevention of Alzheimer’s disease and understanding how much and how often is the subject of ongoing research.
Other researchers have focused on slowing the progression of Alzheimer’s disease. That has led to the development of medications like Aricept and Namenda, which modify the neurotransmitters in the brain and prevent cell death.
Another research project focuses on modifying the “tau” proteins in the brain, which can cause tangles of proteins in brains of Alzheimer’s patients. In laboratory studies with mice, recently an anti-tau drug called bexarotene appeared to reduce plaque buildup in the brain associated with Alzheimer’s. This is an important finding that may lead to clinical studies with patients in the next few years.
All of us at the Roskamp Institute hope these global research efforts will result in new strategies to prevent Alzheimer’s disease, reduce the symptoms and finally find an effective treatment.
Ultimately there is unlikely to be a single “magic bullet” to prevent or cure Alzheimer’s disease. Much more likely, we will move toward cocktails of medications, diet and exercise which, in combination, will stop the disease.
The phase III trial of Nilvadipine in Europe is a critical step toward this end and we at the Rosk- amp Institute are proud to be a part of this worldwide effort to defeat this devastating disease.
Michael Mullan, M.D., Ph.D., is president and chief executive of The Roskamp Institute.
