Phase III Study of the Correlation Between Florbetapir F18 PET Imaging and Amyloid Pathology in the Brain
A Phase III Study of the Correlation Between Florbetapir F 18 (18F-AV-45) PET Imaging and Amyloid Pathology
1 other identifier
interventional
226
1 country
25
Brief Summary
The study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid by dissection of the brain at autopsy. Amyloid in the brain is a key feature of Alzheimer's Disease (AD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2008
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
May 7, 2012
CompletedMay 22, 2012
May 1, 2012
1.2 years
March 5, 2009
April 6, 2012
May 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Correlation of Florbetapir-PET Image and Amyloid Plaque Density
Spearman's rank order correlation of the median semi-quantitative visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
at autopsy up to 12 months post-scan
Specificity Analysis
Specificity of florbetapir-PET scan in younger healthy controls presumed to be negative for amyloid. Specificity results are reported as the number of subjects who had a negative scan based on majority of 3 blinded readers.
50-60 min after injection
Secondary Outcomes (1)
Regional Correlation Analysis
at autopsy up to 12 months post-scan
Study Arms (2)
Autopsy Cohort
EXPERIMENTALEnd-of-life subjects (life expectancy \< 6 months) consenting to brain donation at autopsy.
Specificity Cohort
EXPERIMENTALYounger healthy controls presumed to be devoid of beta-amyloid plaques.
Interventions
Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration
Eligibility Criteria
You may qualify if:
- Have a projected life expectancy of ≤ 6 months as determined by the principal investigator (e.g. terminal medical condition) or are already enrolled in a longitudinal study of aging with an autopsy component;
- Can tolerate a 10 minute PET scan; and
- Give informed consent for study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die.
- Cognitively and neurologically healthy males and females 18 to 40 years of age;
- Who had no known risk factors for AD, including:
- Known genetic risk factors for AD, including an ApoE ε4 allele (note: ApoE genotype was determined after enrollment and was not disclosed to healthy control subjects). Scans from subjects carrying an ApoE ε4 allele were not included in the primary specificity analysis, but were included in an exploratory analysis;
- First degree relative with a known progressive dementing disorder;
- History of cognitive decline;
- History of neurologic, neurodegenerative, or psychiatric disease;
- History of head trauma; or
- Evidence of brain abnormality on a MRI scan;
- Who performed in an age-appropriate normal range on the Wechsler Logical Memory I \& II, story A;
- Who could tolerate a 10-minute PET scan; and
- Who provided informed consent before any study procedures were performed.
You may not qualify if:
- Have primary brain tumor, known metastases to the brain, central nervous system (CNS) lymphoma;
- Have any major, focal structural loss of brain matter;
- Are aggressively being treated with life sustaining measures (e.g. currently on respirator; receiving high dose chemotherapy);
- Have a clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous positive test for hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);
- Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
- Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, secretase inhibitor);
- Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
- Are females of childbearing potential who are pregnant or not using adequate contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Research Site
Phoenix, Arizona, 85006, United States
Research Site
Scottsdale, Arizona, 85258, United States
Research Site
Sun City, Arizona, 85351, United States
Research Site
Little Rock, Arkansas, 72211, United States
Research Site
Irvine, California, 92697, United States
Research Site
San Francisco, California, 94109, United States
Research Site
Fort Myers, Florida, 33912, United States
Research Site
Miami, Florida, 33137, United States
Research Site
Miami Beach, Florida, 33140, United States
Research Site
Miami Springs, Florida, 33166, United States
Research Site
Orlando, Florida, 32835, United States
Research Site
Sarasota, Florida, 34231, United States
Research Site
St. Petersburg, Florida, 33709, United States
Research Site
West Palm Beach, Florida, 33407, United States
Research Site
Baltimore, Maryland, 21221, United States
Research Site
Hattiesburg, Mississippi, 39401, United States
Research Site
St Louis, Missouri, 63141, United States
Research Site
Albany, New York, 12208, United States
Research Site
New Hyde Park, New York, 11040, United States
Research Site
Durham, North Carolina, 27710, United States
Research Site
Centerville, Ohio, 45459, United States
Research Site
Oklahoma City, Oklahoma, 73112, United States
Research Site
Charleston, South Carolina, 29425, United States
Research Site
Johnson City, Tennessee, 37614, United States
Research Site
Bennington, Vermont, 05201, United States
Related Publications (2)
Clark CM, Schneider JA, Bedell BJ, Beach TG, Bilker WB, Mintun MA, Pontecorvo MJ, Hefti F, Carpenter AP, Flitter ML, Krautkramer MJ, Kung HF, Coleman RE, Doraiswamy PM, Fleisher AS, Sabbagh MN, Sadowsky CH, Reiman EP, Zehntner SP, Skovronsky DM; AV45-A07 Study Group. Use of florbetapir-PET for imaging beta-amyloid pathology. JAMA. 2011 Jan 19;305(3):275-83. doi: 10.1001/jama.2010.2008.
PMID: 21245183RESULTClark CM, Pontecorvo MJ, Beach TG, Bedell BJ, Coleman RE, Doraiswamy PM, Fleisher AS, Reiman EM, Sabbagh MN, Sadowsky CH, Schneider JA, Arora A, Carpenter AP, Flitter ML, Joshi AD, Krautkramer MJ, Lu M, Mintun MA, Skovronsky DM; AV-45-A16 Study Group. Cerebral PET with florbetapir compared with neuropathology at autopsy for detection of neuritic amyloid-beta plaques: a prospective cohort study. Lancet Neurol. 2012 Aug;11(8):669-78. doi: 10.1016/S1474-4422(12)70142-4. Epub 2012 Jun 28. Erratum In: Lancet Neurol. 2012 Aug;11(8):658.
PMID: 22749065DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Avid Radiopharmaceuticals
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Avid Radiopharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 6, 2009
Study Start
December 1, 2008
Primary Completion
March 1, 2010
Study Completion
May 1, 2010
Last Updated
May 22, 2012
Results First Posted
May 7, 2012
Record last verified: 2012-05