Future Opportunities to Leverage the Alzheimer's Disease Neuroimaging Initiative Workshop Summary (2011) / Chapter Skim
Currently Skimming:
Workshop Summary
Workshop Summary
Pages 1-18
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 1... ...
.1 Held in Honolulu, HI, on July 12, 2010, the session was designed to explore future opportunities to leverage the Alzheimer's Disease Neuroimaging Initiative (ADNI) , with particular focus on the second phase of the ADNI project, ADNI 2.
|
From page 2... ...
valley of Death Translational research in the neurosciences is advancing as a result of sophisticated tools and the availability of solid data, but the burden of disease remains great. For translational research in general, an ongoing challenge is bridging the "valley of death," the gap between federally funded early research and innovation and product development that is generally conducted by commercial entities.
|
From page 3... ...
A second phase, ADNI 2, has now been funded and will be based on a similar public–private partnership model. The overall goals and research objectives of ADNI 2 include following the cognitively normal and MCI subjects from ADNI 1 and adding more groups of these subjects, along with early AD and early MCI cohorts.
|
From page 4... ...
The Alzheimer's Association, through the World Wide Alzheimer's Disease Neuroimaging Initiative (WW-ADNI) , is planning to standardize the methods used for conducting the science to help ensure the data from all international sites can be readily compiled and analyzed.
|
From page 5... ...
, the Fast Forward initiative of the Multiple Sclerosis Society, the ALS Association, the Huntington's Dieasese Society of America, and the International Retinal Research Foundation. Examples of public–private partnerships that address multiple neurological disorders include the new degenerative dementia-focused Competence Network of the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung)
|
From page 6... ...
These two commonalities may not currently exist for other dementias, so expansion may be premature. Instead, as will be discussed in the final section of this report, a need was identified to expand the worldwide ADNI efforts to include larger cohorts of individuals that help to identify sensitive biomarkers (which may include genetics, behavioral, physiological, and biochemical biomarkers)
|
From page 7... ...
Researchers believed that the effect of a drug on the pathophysiological mechanisms of AD in the brain could be evaluated in clinical trials by using neuroimaging and fluid biomarkers. Development of the neuroimaging initiative began in 2002, with planning meetings involving the NIH, the FDA, academia, and industry.
|
From page 8... ...
More than 150 publications have been based on ADNI data, Buckholtz said, focusing on a variety of research issues, including: which measures or combinations of measures are best for assessing progression from MCI to Alzheimer's disease, and from normal cognition to MCI; which measures are most sensitive to change over time; and which measures are associated in either a positive or negative direction with each other. ADNI data also have been analyzed for power calculations to determine the sample sizes needed to detect a change in clinical trials.
|
From page 9... ...
A new PET amyloid imaging ligand, called AV-45, will be used to image brain beta-amyloid in all subjects. As ADNI comes to a close, an application has been submitted to the NIH for ADNI 2, which, if funded, would enroll and assess additional early and late MCI, normal control, and mild AD subjects, as well as follow the original and ADNI-GO cohorts for an additional 5 years.
|
From page 10... ...
. Consistent with the goals of WW-ADNI, Sawada noted that many of the tests in the clinical test battery used in J-ADNI are compatible with the North American ADNI test battery, and the study protocols were designed to allow for possible clinical data exchange with the U.S.
|
From page 11... ...
, PET Tau imaging, and functional MRI. There is an interest in genotype-driven research, possibly including wholegenome sequencing of beta-amyloid-positive cognitively normal individuals.
|
From page 12... ...
IMI is the European Commission's research plan to foster drug development by promoting public–private partnerships between academia and other public research entities, and the pharmaceutical industry. Frisoni noted that 15 projects have been funded already, including research on AD, cancer, diabetes, pain, depression, schizophrenia, respiratory diseases, and basic pharmacology.
|
From page 13... ...
partnership to develop a global computational infrastructure to advance integrated imaging analysis and foster global science on neurodegenerative conditions. Australian Imaging Biomarkers and Lifestyle Flagship Study In late 2005, Australia's national science agency, the Commonwealth Science and Industrial Research Organization (CSIRO)
|
From page 14... ...
Later, additional contributions for specific projects were obtained from Pfizer for blood biomarker analysis costs; the Alzheimer's Association for costs associated with data release via the ADNI/ LONI website; the Alzheimer's Drug Discovery Foundation to cover 3 years of PiB/MRI imaging; and an anonymous foundation for genetic analysis and extended amyloid imaging. Additional funding was also obtained from the National Health and Medical Research Council.
|
From page 15... ...
ADNI is valuable to industry partners as it provides clinical data from which to evaluate the longitudinal course of the disease, effect sizes on outcome measures, effects of varying covariates, and the use of acetylcholinesterase inhibitors (AChEIs)
|
From page 16... ...
. The new criteria are based on the core clinical feature of a hippocampal pattern of memory loss reflecting the earliest and most typical stages of disease, supported by at least one or more AD biomarkers reflecting either molecular neuropathology or downstream brain effects (presence of medial temporal lobe atrophy; abnormal CSF biomarker; specific pattern on functional neuroimaging with PET; or proven AD autosomal dominant mutation within the immediate family)
|
From page 17... ...
As a result companies have no incentive to go back and redo clinical trials of off-patent products in presymptomatic individuals. Therefore, without changes in IP rules it will be difficult for companies to invest in the development of treatments for neurodegenerative disorders, such as AD.
|
From page 18... ...
Panelists noted their concerns that resources may still be constrained, and broadening ADNI efforts beyond AD could create competition for funding. The sentiment was that there is a need to push for targeted funding of a longitudinal study of a presymptomatic AD cohort, and to identify novel ways to engage industry and incentivize long-term investment in study of the prodromal cohort.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.