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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

About this trial

This is an interventional screening trial for Parkinson Disease focused on measuring ANAM, Parkinson's

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

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

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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