Use of [123I] AV39 and SPECT Imaging as a Marker of Protein Disposition in Subjects With Alzheimer Disease Compared to Healthy Subjects
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
|Official Title:||Evaluation of [123I] AV39 and SPECT as a Marker of Beta-Amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects|
- Assess the dynamic uptake and washout of 123-I AV39
- Blood metabolite characterization of 123-I AV39 in healthy and AD subjects to determine the metabolic fate and nature of metabolites
- Evaluate the test/retest reproducibility of 123-I AV39 and SPECT in AD subjects and healthy controls
|Study Start Date:||February 2007|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Approximately 20 patients with Alzheimer's disease (AD) and 10 healthy controls will be recruited to participate in this study. Healthy controls will be examined to ensure that there is no evidence of neurodegenerative changes including cognitive decline.
All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations.
Subjects will be asked to undergo a bolus injection of 123-I AV39. Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I AV39 in plasma (both protein bound and free) over a period of up to 6 hours.
Subjects may be asked to undergo a second imaging visit between 2 and 6 weeks following the initial imaging visit following similar procedures to the initial imaging visit to evaluate the reproducibility of the imaging measure using this procedure. The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition.
The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I AV39. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the AD patients and controls will be compared.
For those subjects undergoing repeat imaging visits, the data from the initial scan will be compared to the second scan to determine which offers the reproducibility of the imaging outcome measure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439010
|United States, Connecticut|
|Molecular NeuroImaging, LLC|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Danna Jennings, MD||Molecular NeuroImaging, LLC|