Ancillary Longitudinal CSF Collection Study in the Harvard Biomarker Study - HBS2
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2012 |
| End Date: | September 2017 |
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-quality biosamples and high-resolution clinical phenotypes are tracked at
three visits over a two-year period for more than 2,000 individuals with early-stage PD,
MCI/AD, and controls without neurologic disease.
The present "Ancillary Longitudinal CSF Collection Study (short HBS2)" is an ancillary study
to the parent Harvard Biomarker Study. HBS2 is funded by the NINDS. In HBS2, 75 participants
are more intensely studied and followed over a three-year time period. Clinical data and
blood biospecimens are collected every six months and four annual CSF collections are
performed. Biospecimens and clinical data are deposited into the NINDS PD Biomarkers Program
(PDBP) Repository and the Data Management Resource (DMR) and are accessible through the PDBP
DMR website.
discovering, replicating, and developing biomarkers for Parkinson's disease and Alzheimer's
disease. High-quality biosamples and high-resolution clinical phenotypes are tracked at
three visits over a two-year period for more than 2,000 individuals with early-stage PD,
MCI/AD, and controls without neurologic disease.
The present "Ancillary Longitudinal CSF Collection Study (short HBS2)" is an ancillary study
to the parent Harvard Biomarker Study. HBS2 is funded by the NINDS. In HBS2, 75 participants
are more intensely studied and followed over a three-year time period. Clinical data and
blood biospecimens are collected every six months and four annual CSF collections are
performed. Biospecimens and clinical data are deposited into the NINDS PD Biomarkers Program
(PDBP) Repository and the Data Management Resource (DMR) and are accessible through the PDBP
DMR website.
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)
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