Navigation Links
Use Biomarkers in Alzheimer's Disease Clinical Trials, Says Expert Group

WASHINGTON, Jan. 4, 2012 /PRNewswire-USNewswire/ -- A group of thought leaders in Alzheimer's disease says the science is solid and the time has come for more widespread use of biomarkers in Alzheimer disease (AD) clinical trials, to speed the identification of effective disease-modifying treatments for this incurable disorder. Recommendations by the Alzheimer's Disease Biomarker Expert Working Group, convened by the not-for-profit Alliance for Aging Research in cooperation with the Food and Drug Administration, are published this month in a special issue of Neurobiology of Aging.

Co-chaired by Dr. John C. Morris of Washington University, St. Louis, and Dr. Dennis J. Selkoe of Harvard, the Working Group systematically examined published research and determined the current status of biomarkers for AD, their potential for use in the design and conduct of clinical trials, and additional data that might be needed to fully establish their usefulness.

"The commissioned papers in this peer-reviewed journal provide a way forward to the FDA and to industry in the use of biomarkers in AD trials," said Dr. Morris, professor of neurology at the Washington University School of Medicine.  "Our consensus is that certain available AD biomarkers have been sufficiently studied and validated in many populations and can be strongly recommended for use in clinical trials," he said.

Morris and Selkoe noted that the benefits of using AD biomarkers in clinical trials include a greater precision than cognitive assessment tools in measuring dementia progression, requiring fewer participants studied for less time and reducing the cost of trials. Biomarkers can allow for selective enrollment of "relatively rapid decliners," meaning fewer participants and less time to demonstrate treatment effect. They also said biomarkers enhance an investigator's confidence that patients are accurately diagnosed with AD.

"We view this white paper as representing a tipping point and a message to regulators that certain biomarkers already hold much promise to improve the process of testing new disease-modifying therapies for Alzheimer's," said Dr. Selkoe, professor at the Center for Neurologic Diseases at Brigham and Women's Hospital, Harvard and Harvard Medical School. "We recommend that investigators embrace the use of these biomarkers, as more frequent uptake can further hone their effectiveness."

The Working Group recommended that certain AD biomarkers – structural MRI, brain amyloid imaging and cerebrospinal fluid levels of amyloid beta-protein 42 (AB42) and tau – should be used for enrollment and as an outcome in AD clinical trials, along with current clinical assessments, such as neuropsychological testing and the mini-mental state exam (MMSE) and assessment of activities of daily living (ADL).  However, the Group also noted that AD biomarkers must undergo validation and reliability studies in non-research settings before their clinical utility in clinical practice can be determined.

Biomarkers for AD can be divided broadly into those that identify the aspects of the molecular pathology of AD and those that reflect the "downstream" consequences of that pathology. The neuropathological hallmarks that define AD are the amyloid plaques and neurofibrillary tangles found in the brains of AD patients upon autopsy. Amyloid plaques develop when the AB 42 protein accumulates in increasingly insoluble forms, and neurofibrillary tangles develop when tau proteins accumulate inside neurons and form insoluble filaments. Both AB 42 and tau can be measured in cerebrospinal fluid.

Certain imaging tests detect more "downstream" events that follow events initiated at the molecular level. For example, structural magnetic resonance imaging (MRI) can help detect neuronal loss and brain shrinkage caused by AD.

The Alliance for Aging Research and a coalition of non-profit organizations it chairs known as ACT-AD, for Accelerate Cure/Treatments for Alzheimer's Disease, is at the forefront of efforts to advance the development of transformational therapies for Alzheimer's disease. There are currently no approved therapies that can prevent, cure or even substantially slow the progression of dementia caused by AD, whose costs topped $172 billion in 2010. The cost of AD is expected to rise to well over $1 trillion in 2050, even without adjusting for inflation, according to the Alzheimer's Association.

"The Alliance is committed to working closely with scientific leaders and the Food and Drug Administration to provide an expert perspective about how to use AD biomarkers most effectively for therapeutic discovery." said Daniel P. Perry, president and CEO of the Alliance. "The incorporation of biomarkers into Alzheimer's disease clinical trials can help us make real progress in the discovery of new treatments to break the back of this disease."

The private, not-for-profit Alliance for Aging Research is a national citizen advocacy organization working to improve the lives of Americans as they grow older by advancing biomedical and behavioral research in aging and health. The Alliance was founded in 1986 to promote and accelerate medical and scientific research into aging. As America's Baby Boom is transformed into an unprecedented Senior Boom, the Alliance is a valued and respected voice in the nation's capital: developing, implementing and advocating programs in research, health education and public policy.

SOURCE Alliance for Aging Research
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Biomarkers - Technologies, Markets and Companies
2. Global Biomarkers Industry
3. Quanterix Digital ELISA Measures Low Abundance Biomarkers of Inflammation in Crohns Disease
4. Biomarkers: Technological and Commercial Outlook 2011-2021 - Discovering the Pharma and Diagnostics Opportunities
5. Reportlinker Adds Biomarkers: Technologies and Global Markets
6. New Biomarkers Study Could Lead to Better Malaria Vaccine Design
7. Transgenomic, Inc. Presentations to Describe High-Sensitivity Detection of Cancer Biomarkers at the 2011 American Association for Cancer Research Meeting
8. Reportlinker Adds Biomarkers - Technologies, Markets and Companies
9. Vermillion Announces Notice of Allowance of Patent for Breast Cancer Biomarkers
10. Reportlinker Adds Biomarkers - Technologies, Markets And Companies
11. Biomarkers in Late Stage Clinical Trials: Applications, Opportunities and Activities of Leading Players
Post Your Comments:
(Date:11/24/2015)... ... November 24, 2015 , ... The United States Golf Association (USGA) today announced ... Section Award. Presented annually since 1961, the USGA Green Section Award recognizes an individual’s ... , Clarke, of Iselin, N.J., is an extension specialist of turfgrass pathology ...
(Date:11/24/2015)... - iCo Therapeutics ("iCo" or "the Company") (TSX-V: ICO) ... quarter ended September 30, 2015. Amounts, unless specified ... under International Financial Reporting Standards ("IFRS"). ... Andrew Rae , President & CEO of iCo ... value enriching for this clinical program, but also ...
(Date:11/24/2015)... /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ:  AEZS) (TSX: AEZ) (the ... the Toronto Stock Exchange, confirms that as of the ... developments that would cause the recent movements in the ... --> About Aeterna Zentaris Inc. ... Aeterna Zentaris is a specialty biopharmaceutical company engaged in ...
(Date:11/24/2015)... ... 2015 , ... This fall, global software solutions leader SAP and AdVenture Capital ... and pitch their BIG ideas to improve health and wellness in their schools. , ... win the title of SAP's Teen Innovator, an all-expenses paid trip to Super Bowl ...
Breaking Biology Technology:
(Date:11/10/2015)... 10, 2015  In this report, the ... of product, type, application, disease indication, and ... report are consumables, services, software. The type ... biomarkers, efficacy biomarkers, and validation biomarkers. The ... diagnostics development, drug discovery and development, personalized ...
(Date:11/4/2015)... York , November 4, 2015 ... a new market report published by Transparency Market Research "Home ... Growth, Trends and Forecast 2015 - 2022", the global home ... US$ 30.3 bn by 2022. The market is estimated ... forecast period from 2015 to 2022. Rising security needs ...
(Date:10/29/2015)... , Oct. 29, 2015 Daon, a global ... it has released a new version of its ... North America have already installed ... also includes a FIDO UAF certified server component ... preparing to activate FIDO features. These customers include some ...
Breaking Biology News(10 mins):