Evaluation of [123I] MNI-187 and SPECT in Patients With Alzheimers Disease in Comparison to Healthy Subjects
Procedure: 123-I MNI-187 Injection and Imaging Procedures
Institute for Neurodegenerative Disorders has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluation of [123I] MNI-187 and SPECT as a Marker of Beta-Amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects|
- To assess the dynamic uptake and washout of 123-I MNI-187
- Blood metabolite characterization of 123-I MNI-187 in healthy and AD subjects to determine the metabolic fate and nature of metabolites; Evaluate the test/retest reproducibility of 123-I MNI-187 and SPECT in AD subjects and healthy controls [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Approximately 14 patients with Alzheimer's disease (AD) and 12 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 MNI-187. Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I MNI-187 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 MNI-187. 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: NCT00456417
|United States, Connecticut|
|Institute for Neurodegenerative Disorders|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Danna Jennings, MD||Institute for Neurodegenerative Disorders|