Pilot Study To Assess Effect of Treatment and Adherence in PD Subjects

Completed · Phase 1

Conditions studied: Parkinson Disease

In brief

The purpose of this study is to evaluate the impact of imaging the brain as a diagnostic tool in the management of early Parkinson's disease (PD).

Key facts

Study ID

NCT01788696

Run by

Duke University

People needed

20

Starts

2012-06-01

Expected to finish

2015-06-01

Last updated by the study team

2015-06-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age 18-80;
• diagnosis of idiopathic PD exhibiting at least 2 of 3 cardinal signs (bradykinesia, rigidity and resting tremor);
• maximum duration of previous exposure to anti-parkinsonian therapy being < 8 weeks;
• ability to signed informed consent;
• willingness and ability to complete medication diary and questionnaires;
• if a female subject of child-bearing potential, the use of an effective method of contraception.

You may not qualify if…

• current treatment with anti-parkinsonian medication;
• previous treatment with anti-parkinsonian medication for greater than 8 weeks;
• inability to complete questionnaires;
• unwillingness to complete all questionnaires and medication diary;
• subjects with secondary causes of parkinsonism;
• participant has evidence of clinical significant thyroid disease, gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other medical or psychiatric disorder;
• positive serum/urine pregnancy test at any time during the study period;
• the participant has a history of alcohol, narcotic, or any other drug abuse as defined by the DSM-IV within the past 2 years;
• participation in a concurrent PD trial within 60 days.

Where it is running

• Duke University Health Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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