This trial is active, not recruiting.

Condition parkinson's disease
Sponsor Brigham and Women's Hospital
Collaborator National Institute of Neurological Disorders and Stroke (NINDS)
Start date September 2012
End date September 2017
Trial size 76 participants
Trial identifier NCT01867788, NS082157, U01NS082157


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Mean difference in the relative abundance of prioritized transcripts measured in CSF in the PD group compared to the healthy control group.
time frame: Enrollment visit

Eligibility Criteria

Male or female participants at least 21 years old.

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)

Additional Information

Official title Ancillary Longitudinal CSF Collection Study in the Harvard Biomarker Study - HBS2
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.