Development of Cognitive Assessment Tools in Parkinson Disease (ANAM)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
[123I] IBVM and SPECT imaging
Subjects will undergo the 123-I IBVM imaging visit
Sponsored by
About this trial
This is an interventional screening trial for Parkinson Disease focused on measuring ANAM, Parkinson's
Eligibility Criteria
Inclusion and Exclusion Criteria
PD subjects
Inclusion criteria:
- The participant is 30 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of Parkinson's disease based on Brain Bank Criteria.
- Mini-mental status examination (MMSE) score ≥24 or significant cognitive dysfunction based clinical mental status exam.
- Geriatric Depression Scales (GDS) ≤ 10.
- For females, non-child bearing potential a negative urine or serum pregnancy test on day of 123-I IBVM injection.
Exclusion criteria:
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
- Pregnancy
Healthy Control Subjects
Inclusion criteria:
- The participant is 50 years or older.
- Written informed consent is obtained.
- Negative history of neurological or psychiatric illness based on evaluation by a research physician.
- Mini-Mental Status Exam score ≥28.
- For females, non-child bearing potential a negative urine or serum pregnancy test on day of 123-I IBVM injection.
Exclusion criteria:
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
- The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
- The subject has received an investigational drug within 60 days before the screening visit.
Sites / Locations
- Institute for Neurodegenerative Disorders
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
2 cohorts
Arm Description
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
Outcomes
Primary Outcome Measures
The overall goal of this proposal is to validate ANAM-PD as an assessment tool for cognitive status in PD
Secondary Outcome Measures
Full Information
NCT ID
NCT00556764
First Posted
November 8, 2007
Last Updated
February 8, 2012
Sponsor
Institute for Neurodegenerative Disorders
Collaborators
United States Department of Defense, University of Oklahoma
1. Study Identification
Unique Protocol Identification Number
NCT00556764
Brief Title
Development of Cognitive Assessment Tools in Parkinson Disease
Acronym
ANAM
Official Title
Development of Cognitive Assessment Tools in Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for Neurodegenerative Disorders
Collaborators
United States Department of Defense, University of Oklahoma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
ANAM, Parkinson's
7. Study Design
Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 cohorts
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
[123I] IBVM and SPECT imaging
Other Intervention Name(s)
FUNCTIONAL BRAIN IMAGING
Intervention Description
Subjects will be injected with up to 4 mCi of 123-I IBVM followed by SPECT imaging.
Intervention Type
Drug
Intervention Name(s)
Subjects will undergo the 123-I IBVM imaging visit
Other Intervention Name(s)
FUNCTIONAL BRAIN IMAGING
Intervention Description
Subjects will be injected with a bolus of up to 4 mCi of 123-I IBVM followed by serial SPECT imaging.
Primary Outcome Measure Information:
Title
The overall goal of this proposal is to validate ANAM-PD as an assessment tool for cognitive status in PD
Time Frame
6 mos
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion and Exclusion Criteria
PD subjects
Inclusion criteria:
The participant is 30 years or older.
Written informed consent is obtained.
Participants have a clinical diagnosis of Parkinson's disease based on Brain Bank Criteria.
Mini-mental status examination (MMSE) score ≥24 or significant cognitive dysfunction based clinical mental status exam.
Geriatric Depression Scales (GDS) ≤ 10.
For females, non-child bearing potential a negative urine or serum pregnancy test on day of 123-I IBVM injection.
Exclusion criteria:
The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
Pregnancy
Healthy Control Subjects
Inclusion criteria:
The participant is 50 years or older.
Written informed consent is obtained.
Negative history of neurological or psychiatric illness based on evaluation by a research physician.
Mini-Mental Status Exam score ≥28.
For females, non-child bearing potential a negative urine or serum pregnancy test on day of 123-I IBVM injection.
Exclusion criteria:
The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
The subject has received an investigational drug within 60 days before the screening visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danna L Jennings, MD
Organizational Affiliation
Institute for Neurodegenerative Disorders
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11935451
Citation
Kabat MH, Kane RL, Jefferson AL, DiPino RK. Construct validity of selected Automated Neuropsychological Assessment Metrics (ANAM) battery measures. Clin Neuropsychol. 2001 Dec;15(4):498-507. doi: 10.1076/clin.15.4.498.1882.
Results Reference
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Development of Cognitive Assessment Tools in Parkinson Disease
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