• Alzheimer’s Disease Neuroimaging Initiative Announced – October 13, 2004
  
  
• FDA-HST Announces Memorandum of Understanding - August 9, 2004
  
  
• Medicare Proposes to Cover PET Scans for Patients Suspected of Alzheimer’s Disease - June 17, 2004
  

Alzheimer’s Disease Neuroimaging Initiative Announced – October 13, 2004

The National Institute on Aging, together with other government agencies and a number of pharmaceutical companies, announced today the launch of a new $60M, 5-year public-private partnership to study whether serial MRI and PET imaging can measure the progression of Alzheimer’s Disease.  The initiative involves the National Institute of Biomedical Imaging and Bioengineering, the Food and Drug Administration, as well as Pfizer, Wyeth, Eli Lilly, Merck, GlaxoSmithKline, Astra/Zeneca, Norvartis, Eisai, Elan, the Institute for the Study of Aging, and the Alzheimer’s Association.

Additional information can be found at the NIA web site.



FDA-HST Announces Memorandum of Understanding - August 9, 2004

The U.S. Food and Drug Administration (FDA) and the Harvard-MIT Division of Health Sciences and Technology (HST) have executed a memorandum of understanding (MOU), dated 29 March 2004, which formalizes a collaborative research relationship.

Under the auspices of this MOU, the FDA and HST are collaborating in research that, among other things, seeks to characterize the use of imaging biomarkers in clinical trials and regulatory approval.

“This MOU reflects the mutual interest we and the FDA have in identifying the potential of imaging biomarkers,” said A. Gregory Sorensen, HST faculty member and the director of the MGH-HST Center for Biomarkers in Imaging. “Bringing together the strengths of the academic community and the FDA to critically examine the strengths, weaknesses, and possibilities of imaging biomarkers will allow us to better understand how to use these new tools to improve the development of novel therapies.”

The announcement, which appeared in the 2 August 2004 Federal Register (v. 69, no. 147, p. 46157) (Download .pdf)

The MOU can be viewed in its entirety (Download .pdf)


Medicare Proposes to Cover PET Scans for Patients Suspected of Alzheimer’s Disease - June 17, 2004

The Centers for Medicare & Medicaid Services (CMS) recently announced that it intends to expand Medicare coverage of PET (positron emission tomography) imaging for Medicare patients with suspected Alzheimer’s disease.

The CMS announcement (Read Press Release)

Washington Post story on this announcement (Read Press Release)