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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01867788
First Posted: June 4, 2013
Last Update Posted: January 12, 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. Read our disclaimer for details.
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Harvard Medical School
Information provided by (Responsible Party):
Clemens Scherzer, MD, Brigham and Women's Hospital
  Purpose

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.


Condition
Parkinson's Disease

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Ancillary Longitudinal CSF Collection Study in the Harvard Biomarker Study - HBS2

Resource links provided by NLM:


Further study details as provided by Clemens Scherzer, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
Whole blood, plasma, CSF, RNA, DNA

Enrollment: 76
Study Start Date: September 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Parkinson's disease subjects
Healthy Control subjects

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Two tertiary care centers.
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867788


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Harvard Medical School
  More Information

Responsible Party: Clemens Scherzer, MD, Associate Professor of Neurology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01867788     History of Changes
Other Study ID Numbers: NS082157
U01NS082157 ( U.S. NIH Grant/Contract )
First Submitted: May 30, 2013
First Posted: June 4, 2013
Last Update Posted: January 12, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases