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Status unknownNCT01867788HBS2Updated Jan 12, 2016

Ancillary Longitudinal CSF Collection Study in the Harvard Biomarker Study - HBS2

An observational study in Parkinson's Disease, sponsored by Brigham and Women's Hospital. Status unknown at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-12.

Sponsored by Brigham and Women's Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
76
Ages
21 Years and older
Sex
All
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Study 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-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.

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Conditions studied

  • Parkinson's Disease

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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 76 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Two tertiary care centers.

Eligibility criteria

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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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
76 participants (actual)
Target follow-up
36 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Parkinson's disease subjects
  • Healthy Control subjects
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What researchers measure

Primary outcomes

  1. 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

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Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01867788
Lead sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Harvard Medical School (HMS and HSDM)
Responsible party
Clemens Scherzer, MD (Associate Professor of Neurology, Brigham and Women's Hospital) — Principal investigator
First posted
Jun 4, 2013
Start date
Sep 2012
Primary completion
Sep 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Jan 12, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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