Alzheimer's Research: The Role of Secondary Prevention, Exercise, Agitation Treatment and Biomarkers

Alzheimer's Research: The Role of Secondary Prevention, Exercise, Agitation Treatment and Biomarkers

01.25.13 | By

Last week, the National Institutes of Health announced its support of four new studies aimed at finding new treatments for Alzheimer's disease. The research projects, which are being administered under the Alzheimer's Disease Cooperative Study (ADCS), reflect the breadth of emerging ideas and the range of stakeholders within the biopharmaceutical ecosystem (government, private companies, academia) working together to tackle this elusive and devastating disease.

The four studies will aim to address four main critical areas:

  • Secondary prevention in a pre-symptomatic population
  • Use of aerobic exercise in older adults with mild cognitive impairment
  • Treatment of disruptive agitation with a generic alpha blocker medication well tolerated in frail and elderly people
  • Long-term evaluation of cerebrospinal fluid and blood plasma biomarkers used to better understand drugs' mechanisms

The long-anticipated first project - the A4 (anti-amyloid treatment in asymptomatic Alzheimer's disease) trial - has created quite a buzz. Led by principal investigator Reisa Sperling, MD, Harvard Medical School, the trial will enroll 1,000 symptom-free participants aged 70-85 who have been shown via a radioactive imaging agent to have amyloid plaques in their brains. Accumulation of amyloid protein is thought to be a fundamental cause of Alzheimer's.

Late last week, Reuters covered the announcement that the drug to be studied in the A4 trial is Eli Lilly and Company's monoclonal antibody solanezumab. As the article points out, two earlier trials of solanezumab fell short of slowing disease progression among study participants with mild-to-moderate symptoms. However, combined data from two Phase III trials demonstrated for the first time a slowing in cognitive decline in patients with only mild symptoms. Over the three-year period of the A4 trial, cognitive tests will be conducted to determine if the medicine helps maintain cognitive health, and imaging tests will monitor structural and functional changes in the brain.

Dr. Sperling also mentioned that the final data from the trial will not be seen until 2018. Meanwhile, other Alzheimer's drugs will be tested beginning next year as part of her project, including a promising class of drugs called beta secretase inhibitors.

This circuitous development path is all too familiar when it comes to Alzheimer's (and other disease states, for that matter). A report issued by PhRMA last year, entitled "Researching Alzheimer's Medicines: Setbacks and Stepping Stones," illustrated that for every research project that succeeded in treating symptoms of Alzheimer's, 34 failed to yield a new medicine.

The A4 trial and the scores of other efforts underway in biopharmaceutical research labs and academic research centers across the U.S. are encouraging. And as reflected in last year's Research and Hope Awards, which honored individuals and teams in academia, the biopharma sector, patient advocacy and caregiving who have contributed significantly to the advancement of hope and research in the fight against Alzheimer's, eventual success will require continued engagement and diligence from many stakeholders in the biopharmaceutical ecosystem.

Other tidbits and resources of interest:

Basic info on Alzheimer's is available on the National Institute on Aging's website.

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