Development of Cognitive Assessment Tools in Parkinson Disease

Completed · Early Phase 1

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT00556764

Run by

Institute for Neurodegenerative Disorders

People needed

75

Starts

2007-07-01

Expected to finish

2011-03-01

Last updated by the study team

2012-02-09

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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