Parkinson's Disease Biomarker Program (PDBP)
This study is ongoing, but not recruiting participants.
First Posted: January 14, 2013
Last Update Posted: December 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
Information from the National Library of Medicine
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|Ages Eligible for Study:
||30 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
(1) de-novo, previously untreated patients within 5 years of symptom onset, n=20, and (2) patients on treatment with and clinically responsive to MAO-B inhibitors, dopamine agonists, amantadine, or levodopa (or combinations), n=220 and (3) healthy control patients without evidence of degenerative nerological disease.
- A diagnosis of idiopathic PD meeting UK PD Society Brain Bank Criteria (Step 1, Step 2, and 2 items present from step 3).1
- Male or female age 30 years or older at time of PD diagnosis, Hoehn & Yahr (H&Y) stage I-IV.
- Confirmation from I-123 Ioflupane SPECT (DatScan®) of dopamine transporter deficit for de-novo, untreated patients.
- Clinical evidence of response to dopaminergic medication (MAO-B inhibitors, dopamine agonists, levodopa, or combinations) in patients on treatment for PD.
- Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
- Able to make visits to UT Southwestern every 6 months for up to 5 years without undue hardship.
- Idiopathic PD, H&Y stage 5, as these will be unable to participate in gait assessments.
- Confirmed or suspected atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
- Presence of definite dementia (MoCA < 17)2.
- For de-novo subjects: received any of the following drugs that might interfere with dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of screening.
- For the prospective CSF cohort: current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
- For the prospective CSF cohort: any condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or known clinically significant coagulopathy or thrombocytopenia.
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.