Status:
UNKNOWN
Ancillary Longitudinal CSF Collection Study in the Harvard Biomarker Study - HBS2
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Harvard Medical School (HMS and HSDM)
Conditions:
Parkinson's Disease
Eligibility:
All Genders
21+ years
Brief Summary
The Harvard Biomarker Study is a Harvard-wide, longitudinal case-control study designed for discovering, replicating, and developing biomarkers for Parkinson's disease and Alzheimer's disease. High-qu...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Cases with PD:
- Age ≥ 21
- UK Parkinson's Disease Society Brain Bank criteria or movement disorder specialist diagnosis of PD
- Hoehn \& Yahr stage ≤ 3.0
- Mini Mental State Exam score \>21 OR authorized legal guardian available to sign consent
- Able to provide informed consent
- Inclusion Criteria for Controls:
- Age ≥ 21
- Absence of any neurological disease
- No family history of a first-degree relative with PD
- Mini Mental State Exam score \>21 OR authorized legal guardian available to sign consent
- Able to provide informed consent
- Exclusion Criteria for Cases and Controls:
- Acquired or inherited bleeding disorders
- Hematologic malignancies
- Hematocrit \< 30
- Active ulcer or active colitis
- Known pregnancy
- Clinical contraindications to lumbar puncture (including: known mass lesion of the CNS or evidence for raised intracranial pressure on fundoscopic exam; abnormal coagulation tests; platelet count \< 50,000; subject on warfarin (coumadin), heparin, dabigatran, rivaroxiban or apixaban; subject on both aspirin and clopidogrel (Plavix); infection near the LP site or spinal deformity; known allergy to lidocaine)
Exclusion
Key Trial Info
Start Date :
September 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01867788
Start Date
September 1 2012
End Date
September 1 2017
Last Update
January 12 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114