Development of Cognitive Assessment Tools in Parkinson Disease (ANAM)
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|ClinicalTrials.gov Identifier: NCT00556764|
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : February 9, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: [123I] IBVM and SPECT imaging Drug: Subjects will undergo the 123-I IBVM imaging visit||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development of Cognitive Assessment Tools in Parkinson Disease|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
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
- The overall goal of this proposal is to validate ANAM-PD as an assessment tool for cognitive status in PD [ Time Frame: 6 mos ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556764
|United States, Connecticut|
|Institute for Neurodegenerative Disorders|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Danna L Jennings, MD||Institute for Neurodegenerative Disorders|