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Official Study Title: Development of Cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. Assessment Tools in Parkinson Disease (ANAM)
Sponsor: Institute for Neurodegenerative Disorders (IND)
Clinicaltrials.gov ID: NCT00556764
Study ID: ANAM-PD-02; 76,160

Summary

The goal of this study is to validate the ANAM-PD computerized cognitive test as a tool to detect cognitive changes in people with Parkinson's disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD). Study investigators will evaluate the sensitivity and specificity of ANAM-PD in detecting cognitive changes in 50 people with a diagnosis of PD, and in 25 healthy participants as a control group.  Control Group (Comparison Group)Clinical trial participants who are given either a standard treatment or a placebo instead of the investigational drug or treatment being tested.

The ANAM-PD battery will be validated against standardized neuropsychological testing. The reliability of the ANAM-PD battery will be evaluated through a test-retest procedure in a secondary phase of 50 participants (25 with PD and 25 without PD). This strategy will establish this method as a standard test to efficiently measure cognitive changes in PD. This study ultimately could help predict sub-sets of people with PD who may be 'at risk' for developing dementia,  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality. and help researchers learn more about cognitive decline in PD.

All participants must reside in Connecticut.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• Less than one month
• Contact trial coordinator listed below.

Eligibility

• Minimum Age: 30
• Maximum Age: 49
• Gender(s) Accepted: Either
• Study is enrolling non-PD participants

Inclusion Criteria

• For people with PD: 30 years or older, diagnosis of PD, cognitive dysfunction, non-child bearing potential/negative pregancy test, written informed consent  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial. obtained.
• For non-PD participants: 50 years or older, written informed consent obtained, negative history of neurological or psychiatric illness based on evaluation by a research physician.

Enrollment

Expected Enrollment: 100 (US)
Date Enrollment Began: Jul 01 2007
Last Updated Date: Mar 31 2008
Trial Post Date: Mar 31 2008
Website: http://clinicaltrials.gov/ct2/show/NCT00556764?term=NCT00556764&rank=1

Primary Contacts and Locations

Connecticut

• Barbara Fussell, RN
  Institute for Neurodegenerative Disorders (IND)
  Phone: (203) 401-4300
  New Haven, CT 06510
  USA