Development of Cognitive Assessment Tools in Parkinson Disease

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institute for Neurodegenerative Disorders
• Collaborators: United States Department of Defense; University of Oklahoma

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.