More coverage this weekend in The New York Times of the Health and Human Services' (HHS) National Alzheimer’s Project Act (NAPA), aimed at developing effective treatments and cures for Alzheimer’s disease (AD) and related dementias by 2025. Last week, we blogged about the announcement of a proposed 2013 budget that would call for a $100 million increase in monies devoted to a five-pronged research and education initiative to fight AD. In Sunday’s Op-Ed section, The Times wrote that the Obama administration plan on the whole, “is a long shot, but the payoff could be huge.”
One of the centerpieces of the plan is a clinical trial of the drug Crenezumab, designed to test whether the therapy could prevent Alzheimer’s in those whose “genetic heritage guarantees that they will one day develop the disease.” Most trial participants will come from the world’s largest family to experience Alzheimer’s, made up of 5,000 people from Medellín, Colombia and its surrounding areas, where family members with a specific genetic mutation begin to show cognitive impairment at around age 45, and advanced stage dementia at around 51.
A prevailing theory in Alzheimer’s research is that plaques or clumps of a small protein called beta-amyloid in the brain may play a major role in causing Alzheimer’s. Crenezumab attacks these plaques.
The truly big payoff will come if the drug succeeds in this group and lays the groundwork for preventing or slowing the progress of Alzheimer’s that appears late in life. The researchers will be gathering data on a variety of biomarkers — glucose activity in the brain, shrinkage of the brain, certain proteins in cerebral spinal fluid, for example — to see which if any are related to preventing amyloid plaques and the loss of mental abilities.
If the drug prevents the deterioration of particular biomarkers and ultimately sustains mental capacity, then the same markers might be useful in identifying and treating older people likely to develop the disease. And federal regulators might be willing to approve other prevention drugs based on their short-term effects on biomarkers, speeding the conduct of clinical trials.