Development of Cognitive Assessment Tools in Parkinson Disease

NCT ID: NCT00556764

Last Updated: 2012-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-03-31

Brief Summary

The main objectives of this protocol are as follows:

1. To assess the sensitivity and specificity of ANAM-PD in detecting cognitive status in patients with Parkinson disease (PD) and healthy controls (HC).

2. 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.

3. 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.

4. 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

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

[123I] IBVM and SPECT imaging

Intervention Type: DRUG

Subjects will be injected with up to 4 mCi of 123-I IBVM followed by SPECT imaging.

Subjects will undergo the 123-I IBVM imaging visit

Intervention Type: DRUG

Subjects will be injected with a bolus of up to 4 mCi of 123-I IBVM followed by serial SPECT imaging.

Interventions

[123I] IBVM and SPECT imaging

Subjects will be injected with up to 4 mCi of 123-I IBVM followed by SPECT imaging.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

FUNCTIONAL BRAIN IMAGING; FUNCTIONAL BRAIN IMAGING

Eligibility Criteria

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.

• 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

PD subjects

• 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

• 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: collaborator

Institute for Neurodegenerative Disorders

OTHER

Sponsor Role: lead

Responsible Party

Danna Jennings, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danna L Jennings, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Neurodegenerative Disorders

Locations

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11935451 (View on PubMed)

Other Identifiers

#76,160

Identifier Type: OTHER

Identifier Source: secondary_id

ANAM-PD-02

Identifier Type: -

Identifier Source: org_study_id