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

NCT ID: NCT01867788

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2017-09-30

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-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.

Conditions

Parkinson's Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Parkinson's disease subjects

No interventions assigned to this group

Healthy Control subjects

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Clemens Scherzer, MD

Associate Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

U01NS082157

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NS082157

Identifier Type: -

Identifier Source: org_study_id