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Sponsors and Collaborators: |
Institute for Neurodegenerative Disorders Department of Defense University of Oklahoma |
Information provided by: | Institute for Neurodegenerative Disorders |
ClinicalTrials.gov Identifier: | NCT00556764 |
The main objectives of this protocol are as follows:
Condition | Intervention | Phase |
Parkinson Disease |
Radiation: [123I] IBVM and SPECT imaging Radiation: Subjects will undergo the 123-I IBVM imaging visit |
Phase 0 |
Genetics Home Reference related topics: | familial paroxysmal nonkinesigenic dyskinesia Parkinson disease |
MedlinePlus related topics: | Degenerative Nerve Diseases Parkinson's Disease |
Study Type: | Interventional |
Study Design: | Screening, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Development of Cognitive Assessment Tools in Parkinson Disease |
Estimated Enrollment: | 100 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
2 cohorts: Experimental
In this observational study 2 cohorts will participate. Cohort 1 will include people with Parkinson disease and Cohort 2 will include healthy volunteers. A subset of twelve subjects (8 PD and 4 HC) will be enrolled in the [123I] IBVM and SPECT imaging portion of this study |
Radiation: [123I] IBVM and SPECT imaging
Subjects will be injected with up to 4 mCi of 123-I IBVM followed by SPECT imaging.
Radiation: Subjects will undergo the 123-I IBVM imaging visit
Subjects will be injected with a bolus of up to 4 mCi of 123-I IBVM followed by serial SPECT imaging.
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General Design and Methods The overall goal of this proposal is to validate ANAM-PD as an assessment tool for cognitive status in PD. We propose a comprehensive strategy to evaluate the sensitivity and specificity of ANAM-PD in detecting cognitive changes in patients with a diagnosis of PD (n=50) and healthy controls (n=25). The specific testing domains of the ANAM-PD battery will be validated against standardized neuropsychological testing, described in detail below. The reliability of the ANAM-PD battery will be evaluated through a test-retest procedure in a subset of 50 subjects (25 PD and 25 HC). This strategy will enable us to evaluate the individual domains of the ANAM-PD computerized cognitive test and establish a battery as a standard test to efficiently measure cognitive changes in PD. We also propose to explore functional neuroimaging of the cholinergic system using [123I] IBVM and SPECT, a marker of vesicular acetylcholine transporter and a measure of the integrity of the cholinergic neuronal system. Identifying and validating ANAM-PD as an efficient tool for assessing cognitive changes in PD and exploring the cholinergic transporter system in PD through functional neuroimaging could predict sub-sets of PD patients 'at risk' for developing dementia and help elucidate the neurochemistry related to cognitive decline in PD
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion and Exclusion Criteria
Parkinson Subject Selection. Subjects who have a clinical diagnosis of Parkinson's disease (PD) will be recruited for this study. The following criteria will be met for inclusion of PD subjects in this study:
Parkinson's subjects will be excluded from participation for the following reasons:
Healthy Control Subject Selection. Healthy control subjects who have no neurological disease will be recruited for this study. The following criteria will be met for inclusion of healthy control subjects in this study:
Healthy control subjects will be excluded from participation for the following reasons:
Contact: Danna L Jennings, MD | 203-401-4300 |
United States, Connecticut | |||||
Institute for Neurodegenerative Disorders | Recruiting | ||||
New Haven, Connecticut, United States, 06510 | |||||
Contact: Debbie Ruotolo 203-401-4300 druotolo@indd.org | |||||
Contact: Barbara Fussell, RN 203-401-4300 | |||||
Principal Investigator: Kenneth Marek, MD |
Institute for Neurodegenerative Disorders |
Department of Defense |
University of Oklahoma |
Principal Investigator: | Danna L Jennings, MD | Institute for Neurodegenerative Disorders |
Responsible Party: | Institute for Neurodegenerative Disorders ( Danna Jennings, M.D. ) |
Study ID Numbers: | ANAM-PD-02, #76,160 |
First Received: | November 8, 2007 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00556764 |
Health Authority: | United States: Food and Drug Administration |
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