Regulatory Focus™ > News Articles > NIH Announces Support for Alzheimer's Clinical Trial, Regulatory Science Initiative

NIH Announces Support for Alzheimer's Clinical Trial, Regulatory Science Initiative

Posted 14 January 2013 | By

The National Institutes of Health (NIH) has announced the launch of four new clinical trials, part of a long-running initiative that hopes to find new treatments for-and maybe even entirely prevent-Alzheimer's disease.

The studies will be conducted by the Alzheimer's Disease Cooperative Study (ADCS), a consortium of academic medical centers, and will test the effects of drugs and exercise on people in the early stages of the disease, NIH wrote in a statement.

Researchers also hope to test a "cutting-edge approach to speed testing of drugs in clinical trials," a potential boon to regulatory professionals working in the Alzheimer's disease space. Any such regulatory science tools would eventually require validation if a product uses it to support a product submission to the US Food and Drug Administration (FDA), but researchers said for now they are just looking to the tool as a validation of a theory.

The five-year project could pump as much as $55 million into the four trials, and the project is being lauded by NIH officials as a "critical" initiative in the country's goal to prevent and treat Alzheimer's by 2025.

"The ADCS is a key initiative in the federal program to discover, develop and test new Alzheimer's treatments and diagnostic tools. Over the years, it has proved invaluable in advancing our understanding about the disease and how to conduct research in this challenging area," said National Institute on Aging (NIA) Director Richard Hodes. "I am particularly excited that this round of studies will use what we have learned by testing interventions pre-symptomatically, 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."

Four Trials, Four Approaches

To that end, the four clinical trials sponsored by NIH seemed geared toward testing several different approaches in the hopes that at least one-and hopefully more-might be effective.

  • The first trial, on the development of amyloid protein-based plaque in the brain, hopes to assess whether earlier treatment of plaque buildup even before the onset of Alzheimer's might prove to be effective to delay or prevent the disease.
  • The second trial aims to assess whether regular physical activity (aerobic exercise, in particular) is sufficient to influence cognitive decline.
  • A third trial, "Prazosin for Treating Agitation," looks to test an existing generic drug, Prazosin, in the hopes that it might reduce agitation in a way that would be well-tolerated in the frail and elderly. Existing treatments, NIH noted, can have deleterious side effects and may be ineffective.
  • The fourth and final trial, "CSF Pharmacodynamic Trial," seeks to "employ advanced methods that sample cerebrospinal fluid (CSF) and plasma levels over time," NIH explained. "These methods will track levels of several Alzheimer's-related proteins to help researchers better understand how a drug influences Alzheimer's pathology and to help guide decisions on whether a drug warrants further clinical testing."

"With this newly funded work, the goal is to expand the range of individuals participating in ADCS clinical trials from those at risk for the disorder to those with Alzheimer's dementia, so that the full spectrum of the disease is represented," concluded Laurie Ryan, director of disease clinical trials at NIA. 

Tags: NIH

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