Re: Study: Avid’s Imaging Dye Can Detect Alzheimer’s From Scan - ICAD 2010 presentation Sunday 11th July 2010
This is the relevant Abstract of the presentation - Sunday, July 11, 2010........snug
Session: Advances in PET Amyloid Imaging
Sunday, Jul 11, 2010, 1:00 PM - 3:00 PM
Presentation: O1-02-03 - Phase III Trial Results for the Amyoid PET Imaging Agent Florbetapir F 18 (18F-AV-45): Imaging to histopathologic correlations in an end of life human subject study
Pres. Time: Sunday, Jul 11, 2010, 1:30 PM - 1:45 PM
Location: Hall 1
Category: +Differential diagnosis
Author(s): Christopher M. Clark, MD1, Julie A. Schneider, MD2, Mark M. A. Mintun, MD3, Barry J. Bedell, MD, PhD4, Thomas G. Beach, MD, PhD5, Carl H. Sadowsky, MD6, P M. Doraiswamy, MD7, Jose Gamez, MD8, Marwan N. Sabbagh, MD9, Adam S. Fleisher, MD10, Frederick Schaerf, MD, PhD11, Malika Waseem, MD12, Michael J. Pontecorvo, PhD1, Franz F. Hefti, PhD1, Daniel M. Skovronsky, MD, PhD1, AV45-A07 Study Group.
1Avid Radiopharmaceuticals, Philadelphia, PA, USA, 2Rush University, Chicago, IL, USA, 3Washington University, St. Louis, MO, USA, 4Biospective Inc., Montreal, QC, Canada, 5Sun Health Research Institute, Sun City, AZ, USA, 6Nova SE University, Ft. Lauderdale, FL, USA, 7Duke University Medical Center, Durham, NC, USA, 8Galiz Research, Miami, FL, USA, 9Banner Sun Health Research Institute, Sun City, AZ, USA, 10Banner Alzheimer’s Institute, Phoenix, AZ, USA, 11Neuropsychiatric Research Center of Southwest Florida, Ft. Myers, FL, USA, 12Waseem, Exon, MD, USA.
A validated PET amyloid tracer could improve diagnosis and management of dementing disorders. We will report the results for the first Phase III multicenter validation study for an amyloid imaging agent, comparing cortical amyloid as evaluated by PET imaging with amyloid burden and plaque density as assessed at post mortem histology in patients with a variety of clinical diagnoses and cognitive performance levels.
Subjects with an estimated life expectancy < 6 months underwent a 10 min PET scan 50 min after iv injection of 10 mCi of florbetapir F 18. Images were rated visually (0 - 4 scale) for global and regional cortical uptake. Mean cortical to cerebellar standard uptake value ratios (SUVr) were also determined in six PET regions. After death brain sections from matching regions were evaluated for density of β-amyloid deposition using a fully-automated, quantitative immunohistochemistry analysis over the entire tissue section (IHC: Signet 4G8 anti-Aβ antibody) and semi-quantitative estimates of total plaque density on Bielschowsky silver stain (modified CERAD scoring). A planned interim analysis was conducted after the 6th autopsy, and the final analysis will be based on the first 35 subjects that came to autopsy.
Interim data showed strong correlations between the visual rating of global amyloid binding on the PET image and post mortem global amyloid burden assessed by global mean IHC (Spearman’s ρ=0.88, p=0.01) and mean modified CERAD score (ρ=0.92, p=0.004). Similar results were obtained for global SUVr (IHC: Pearson’s r=0.89, p=0.009; CERAD score: ρ=0.93, p=0.004). Full results for the Phase III trial on the 35 subjects in the efficacy cohort will be presented.
Preliminary results from an interim analysis of this multicenter Phase III demonstrated that both visual ratings and SUVr values of global florbetapir F 18 amyloid binding on a PET scan were strongly correlated with amyloid burden and plaque density at histopathology. The visual rating requires no special analysis software and thus may provide a method for interpreting amyloid scans in community setting. Final results from the full data set in the primary analysis are expected to be available and will be presented.
Disclosures: C.M. Clark, Avid Radiopharmaceuticals, Employee; J.A. Schneider, Avid Radiopharmaceuticals, Grants/Research Support; M.M.A. Mintun, Avid Radiopharmaceuticals, Consultant; B.J. Bedell, Avid Radiopharmaceuticals, Grants/Research Support; Biospective Inc, Employee; Biospective Inc, Stock Shareholder (directly purchased); Biospective Inc, Board Member/Officer; T.G. Beach, Avid Radiopharmaceuticals, Grants/Research Support; C.H. Sadowsky, Avid Radiopharmaceuticals, Grants/Research Support; P.M. Doraiswamy, Avid Radiopharmaceuticals, Grants/Research Support; BMS, Grants/Research Support; Medivation, Grants/Research Support; Lilly, Grants/Research Support; NINDS, Grants/Research Support; NIMH, Grants/Research Support; Eisai, Grants/Research Support; Elan, Grants/Research Support; AVID RP, Consultant; BMS, Consultant; ScheringPlough, Consultant; Medivation, Consultant; Neuroptix, Consultant; Neuronetrix, Consultant; Bayer, Consultant; Sonexa, Stock Shareholder (directly purchased); Forest, Paid speaker or teacher; Lundbeck, Paid speaker or teacher; J. Gamez, Avid Radiopharmaceuticals, Grants/Research Support; M.N. Sabbagh, Avid Radiopharmaceuticals, Grants/Research Support; Baxter, Grants/Research Support; Bayer, Grants/Research Support; Lilly, Grants/Research Support; Wyeth, Grants/Research Support; Elan, Grants/Research Support; BMS, Grants/Research Support; Power 3, Grants/Research Support; Amerisciences, Consultant; Lilly, Consultant; Eisai, Consultant; Pfizer, Consultant; GSK, Consultant; A.S. Fleisher, Avid Radiopharmaceuticals, Grants/Research Support; F. Schaerf, Avid Radiopharmaceuticals, Grants/Research Support; M. Waseem, Avid Radiopharmaceuticals, Grants/Research Support; M.J. Pontecorvo, Avid Radiopharmaceuticals, Employee; F.F. Hefti, Avid Radiopharmaceuticals, Employee; D.M. Skovronsky, Avid Radiopharmaceuticals, Employee; Avid Radiopharmaceuticals, Board Member/Officer.
EMBARGO: As a reminder: All abstracts accepted for presentation at ICAD are embargoed until the date and time of presentation at the conference, unless the Alzheimer's Association provides written notice of change of date and/or time in advance. Embargo is the prohibition for copyright reasons from releasing any content from a submitted or accepted abstract to the public until after it has been presented at ICAD. Prior to presentation at ICAD, authors may not release information to the news media or the public, nor publish the results in any manner, and must ensure that colleagues and other organizations or institutions are aware of this policy. Violation of the embargo may include retraction of the accepted abstract and/or loss of privileges of presenting research at ICAD in the future.