Development of Cognitive Assessment Tools in Parkinson Disease (ANAM)
The main objectives of this protocol are as follows:
- To assess the sensitivity and specificity of ANAM-PD in detecting cognitive status in patients with Parkinson disease (PD) and healthy controls (HC).
- To validate the specific individual domains of the ANAM-PD cognitive battery by comparisons to available standardized cognitive evaluation scales administered to the patients with Parkinson disease with and healthy control subjects.
- To evaluate the reliability of the ANAM-PD battery of tests by comparing repeated administrations of the ANAM-PD battery on a sub-set of subjects with Parkinson disease and healthy controls.
- To characterize cholinergic neurotransmission through imaging the vesicular acetylcholine transporter binding with 123Iodobenzovesamicol (IBVM) and SPECT in PD patients and healthy controls.
Drug: [123I] IBVM and SPECT imaging
Drug: Subjects will undergo the 123-I IBVM imaging visit
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Development of Cognitive Assessment Tools in Parkinson Disease|
- The overall goal of this proposal is to validate ANAM-PD as an assessment tool for cognitive status in PD [ Time Frame: 6 mos ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Experimental: 2 cohorts
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
Drug: [123I] IBVM and SPECT imaging
Subjects will be injected with up to 4 mCi of 123-I IBVM followed by SPECT imaging.
Other Name: FUNCTIONAL BRAIN IMAGINGDrug: 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.
Other Name: FUNCTIONAL BRAIN IMAGING
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556764
|United States, Connecticut|
|Institute for Neurodegenerative Disorders|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Danna L Jennings, MD||Institute for Neurodegenerative Disorders|