Research Involving Subjects With Parkinson's Disease, Alzheimer Disease and Healthy Controls
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Evaluation of [18F] CFPyPB PET as a Marker of Glycine Transporter-1 (GlyT1) Receptor in Subjects With Parkinson Disease, Alzheimer Disease and Healthy Subjects|
- To assess the dynamic uptake and washout of [18F] CFPyPB [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]To assess the dynamic uptake and washout of [18F] CFPyPB, an imaging tracer targeting the glycine transporter-1 (GlyT1) receptor in brain, using positron emission tomography (PET) in subjects with Parkinson disease (PD) Alzheimer disease (AD) and healthy controls (HC).
- Perform blood metabolite characterization of [18F] CFPyPB [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]To perform blood metabolite characterization of [18F] CFPyPB in subjects with PD, AD and HC to determine the nature of metabolites in assessment of [18F] CFPyPB as a single positron computed tomography (PET) brain imaging agent.
- To obtain safety data [ Time Frame: Approximately 2 years ] [ Designated as safety issue: Yes ]To acquire safety data following injection of [18F] CFPyPB
- Obtain test/retest reproductibility [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]To obtain test/retest reproducibility of quantitative PET outcome measures with [18F] CFPyPB
|Study Start Date:||August 2011|
|Study Completion Date:||May 2014|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Assess [18F] CFPyPB and PET imaging
To assess [18F]CFPyPB and PET imaging
Drug: [18F] CFPyPB
Each subject will receive a bolus injection targeted to be 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of [18F]CFPyPB or 5 μg of CFPyPB (whichever is greatest).
Approximately 6 subjects with Parkinson disease, 6 subjects with Alzheimer disease and 20 healthy control subjects will be recruited to participate in this study. 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 [18F] CFPyPB followed by serial PET imaging scans and plasma sampling for measurement of [18F] CFPyPB in plasma (both protein bound and free) over a period of up to 4 hours. 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, [18F] CFPyPB. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the PD and AD subjects will be compared with the HC subjects.
At least 2 weeks following the initial imaging visit subjects (up to 2 PD subjects, up to 2 AD subjects and up to 5 HC subjects) may be asked to return for a second injection and scanning procedure to evaluate the reproducibility of the imaging measure using this procedure. Subjects may decline participation in the second scan. Subjects will be requested to return for this second scan until enough second scan data is collected to evaluate the imaging outcome measure for reproducibility.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461109
|United States, Connecticut|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||David Russell, MD, PhD||Institute for Neurodegenerative Disorders|