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Development of Cognitive Assessment Tools in Parkinson Disease

NCT00556764 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2012-02-09

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

DRUG

[123I] IBVM and SPECT imaging

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

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Oklahoma

    collaborator OTHER

  • Institute for Neurodegenerative Disorders

    lead OTHER

Principal Investigators

  • Danna L Jennings, MD · Institute for Neurodegenerative Disorders

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00556764 on ClinicalTrials.gov