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

Parkinson's Disease Clinical Trial

— HBS2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01867788
• Other study ID #: NS082157
• Secondary ID: U01NS082157
• Status: Active, not recruiting
• Phase: N/A
• First received: May 30, 2013
• Last updated: January 11, 2016
• Start date: September 2012
• Est. completion date: September 2017

Study information

• Verified date: January 2016
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Harvard Medical School, National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean difference in the relative abundance of prioritized transcripts measured in CSF in the PD group compared to the healthy control group.		Enrollment visit	No