Alzheimer’s research will get a sizable boost this year, with an $11 million grant from the federal government and the promise of up to $55 million by 2018.
The National Institute on Aging allocated the funds to further the Alzheimer’s Disease Cooperative Study (ADCS), a long-term project that many researchers hope could result in more effective treatments – and perhaps even a cure for the disease.
"The ADCS is a key initiative in the federal program to discover, develop, and test new Alzheimer’s treatments and diagnostic tools," Dr. Richard J. Hodes, director of the National Institute on Aging, wrote in a press statement. "Over the years, it has proved invaluable in advancing our understanding about the disease and how to conduct research in this challenging area. I am particularly excited that this round of studies will use what we have learned by testing interventions presymptomatically, as early as we can in the development of the disease, where we now think the best hope lies for keeping Alzheimer’s at bay."
ADCS is a consortium of academic medical centers and clinics set up by NIH in 1991 to collaborate on the development of Alzheimer’s treatments and diagnostic tools. This newest round of studies will test drug and exercise interventions in people in the early stages of the disease, evaluate a medication to reduce agitation in people with Alzheimer’s dementia, and search for a way to speed testing of drugs in clinical trials. The grant makes possible four new studies:
• The Anti-Amyloid Treatment in Asymptomatic Alzheimer’s disease (A4) secondary prevention trial will test an amyloid-clearing drug in the presymptomatic stage of the disease. The study population will consist of 1,000 symptom-free older volunteers who have had positron emission tomography brain images confirming abnormal levels of amyloid. The 3-year trial will probably test a single agent, but the specifics have yet to be announced. However, it’s likely to be a monoclonal antibody, several of which have already shown some activity against beta-amyloid brain plaques, according to principal investigator Dr. Reisa A. Sperling, who is the director of the Center for Alzheimer’s Research and Treatment and professor of neurology at Harvard Medical School, Boston.
• The year-long Exercise MCI Trial seeks to determine how exercise could impact the progression of mild cognitive impairment. Sedentary patients with MCI will be randomized to one of two exercise programs: gentle stretching or vigorous aerobic workouts. Endpoints include changes in cognition, cerebrospinal fluid biomarkers, and brain imaging.
• The Prazosin Treatment for Disruptive Agitation in Alzheimer’s Disease will determine whether prazosin is well tolerated in frail, elderly people as a treatment for agitation. Dr. Elaine R. Peskind, the Friends of Alzheimer’s Research Professor of Psychiatry and Behavioral Sciences at the University of Washington in Seattle, is heading the project, which seeks 120 patients with Alzheimer’s who experience at least two disruptive episodes per week. Patients will be randomized to the drug or placebo for 24 weeks. Endpoints are changes on the Clinical Global Impression of Change and Neuropsychiatric Inventory total score. In 2009, Dr. Peskind and her team conducted a small placebo-controlled trial of 22 Alzheimer’s patients with agitation/aggression. Findings from that study showed that the drug improved behavioral symptoms in patients.
• The CSF Pharmacodynamic Trial will examine how some drugs in development affect levels of beta-amyloid and tau levels over time. The results will help determine whether a drug is a fit candidate for further investigation and a clinical trial.
The announcement of a continuing federal commitment is a valuable contribution to the Alzheimer’s fight, but much more is needed, said William H. Thies, Ph.D., chief medical and scientific officer of the Alzheimer’s Association, Chicago.
"The studies announced today are significant steps in the fight to better treat and eventually prevent Alzheimer’s disease," Dr. Thies said in an interview. "However, because of the chronic underfunding of Alzheimer’s research, there are many more equally valid and necessary investigations that are not happening. The Alzheimer’s Association believes that if we are to more quickly unravel the important questions about Alzheimer’s disease cause, risk, treatment, and prevention, we must make a greater commitment to research."
The first-ever U.S. National Plan to Address Alzheimer’s Disease was unveiled in May 2012, and now this plan must be effectively implemented, he added. "An additional $100 million has been recommended for 2013 for Alzheimer’s research, and now must be confirmed."
Dr. Hodes, Dr. Sperling, Dr. Peskind, and Dr. Thies did not report any financial conflicts of interest.