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:11/25/2015)... CITY , Nov. 25, 2015 /PRNewswire/ - Aeterna ... affirms that its business and prospects remain fundamentally ... , Zoptrex™ (zoptarelin doxorubicin) recently received DSMB recommendation ... to completion following review of the final interim ... Phase 2 Primary Endpoint in men with heavily ...
(Date:11/25/2015)... ... November 25, 2015 , ... Jessica Richman and Zachary Apte, ... their initial angel funding process. Now, they are paying it forward to other ... stage investments in the microbiome space. In this, they join other successful ...
(Date:11/24/2015)... Therapeutics, Inc. (NASDAQ: HALO ) will be presenting at the ... on Wednesday, December 2 at 9:30 a.m. ET/6:30 a.m. PT . ... a corporate overview. th Annual Oppenheimer Healthcare Conference ... a.m. PT . Jim Mazzola , vice president of ... --> th Annual Oppenheimer Healthcare Conference in ...
(Date:11/24/2015)... , Nov. 24, 2015 /PRNewswire/ - Aeterna Zentaris ... of IIROC on behalf of the Toronto Stock Exchange, ... release there are no corporate developments that would cause ... --> --> About Aeterna ... . --> Aeterna Zentaris is a ...
Breaking Biology Technology:
(Date:10/29/2015)... , Oct. 29, 2015  Rubicon Genomics, ... for U.S. distribution of its DNA library preparation ... and Rubicon,s new ThruPLEX Plasma-seq kit. ThruPLEX Plasma-seq ... the preparation of NGS libraries for liquid biopsies--the ... diagnostic and prognostic applications in cancer and other ...
(Date:10/27/2015)... -- Munich, Germany , October ... automatically maps data from mobile eye tracking videos created ... that they can be quantitatively analyzed with SMI,s analysis ... , October 28-29, 2015. SMI,s Automated Semantic Gaze ... tracking videos created with SMI,s Eye Tracking Glasses ...
(Date:10/23/2015)... , Oct. 23, 2015 Research and ... the "Global Voice Recognition Biometrics Market 2015-2019" ... --> The global voice recognition biometrics ... 2014-2019. --> --> ... has been prepared based on an in-depth market analysis ...
Breaking Biology News(10 mins):