Alzheimers Disease Clinical Trial
Official title:
Evaluation of [123I] AV83 and SPECT as a Marker of Beta-Amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
The underlying goal of this study is to assess 123-I AV83 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects.
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 AV83. Subjects will undergo
serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I AV83
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 AV83. 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.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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