Research Involving Subjects With Parkinson's Disease, Alzheimer Disease and Healthy Controls

Phase 1

Completed

• Conditions: Parkinson Disease; Alzheimer Disease
• Interventions: Drug: [18F] CFPyPB

• Registration Number: NCT01461109
• Lead Sponsor: Institute for Neurodegenerative Disorders

Brief Summary

The underlying goal of this study is to assess \[18F\] CFPyPB PET imaging as a tool to evaluate the activity of the GlyT1 receptors in the brain of Parkinson's Disease (PD) and Alzheimer Disease (AD) research participants.

Detailed Description

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-10-25
• Study First Posted: 2011-10-27
• Primary Completion: 2012-09
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-02
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assess [18F] CFPyPB and PET imaging	[18F] CFPyPB	To assess \[18F\]CFPyPB and PET imaging

Primary Outcome Measures

Name	Time	Method
To assess the dynamic uptake and washout of [18F] CFPyPB	Approximately 2 years	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).

Secondary Outcome Measures

Name	Time	Method
Perform blood metabolite characterization of [18F] CFPyPB	Approximately 2 years	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	Approximately 2 years	To acquire safety data following injection of \[18F\] CFPyPB
Obtain test/retest reproductibility	Approximately 2 years	To obtain test/retest reproducibility of quantitative PET outcome measures with \[18F\] CFPyPB

Trial Locations

Locations (1)

Institute_Neurodegenerative_Disorders; 🇺🇸 New Haven, Connecticut, United States