The US government has unveiled what it describes as ambitious plans to fight Alzheimer’s disease, including the development of effective prevention and treatments by 2025.
Kathleen Sebelius, the US Health and Human Services secretary, has launched the 'National Plan to Address Alzheimer’s Disease', part of an act which President Obama signed into law in January. These include the funding of two major clinical trials and the development of "new high-quality, up-to-date training and information for our nation’s clinicians".
The president’s proposed 2013 budget provides a $100 million increase for efforts to combat Alzheimer’s, which includes $80 million for further research. Ms Sebelius said "these actions are the cornerstones of an historic effort to fight Alzheimer’s", noting that “this is a national plan—not a federal one, because reducing the burden of Alzheimer’s will require the active engagement of both the public and private sectors".
Goundbreaking study with Colombian family
The HHS pledge was made as plans were announced for "the first-ever prevention trial in cognitively healthy individuals who are destined to develop Alzheimer's disease because of their genetic history".
The groundbreaking study, a collaboration between the National Institutes of Health, Banner Alzheimer's Institute, the University of Antioquia in Colombia and Roche's Genentech unit is the first to investigate whether an anti-amyloid treatment can stave off the disease.
The $100 million trial will study an experimental anti-amyloid antibody treatment called crenezumab in 300 people from "an extraordinarily large extended family in Colombia", who share a rare genetic mutation that typically triggers Alzheimer's symptoms around the age of 45. The trial will also include a smaller number of individuals in the USA and is designed to determine whether the drug can reduce participants' chances of developing "disabling and irreversible symptoms, preserve memory and thinking abilities, and slow the progression of Alzheimer's biomarkers".
The study will be supported with five-year NIH funding expected to total $16 million, as well as $15 million from BAI. Genentech will contribute the major share of cash, and head of research and early development at the unit, Richard Scheller, said if the trial "demonstrates that we can prevent the disease in this special group of patients, it may pave the way to preventing Alzheimer's in the general population".
Preclinical studies indicate that crenezumab, which Genentech is developing in collaboration with Swiss biotech AC Immune, works by binding to amyloid proteins and clearing them from the brain. It has been studied in both healthy individuals and people with Alzheimer's and currently is being evaluated in a Phase II clinical study in patients with mild to moderate symptoms. No significant safety issues have been detected to date.