Parkinson's DiseaseHBS2NCT01867788
Ancillary Longitudinal CSF Collection Study in the Harvard Biomarker Study - HBS2
An observational study of Parkinson's Disease, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2017
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two tertiary care centers.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease subjects | Not described | |
| Healthy Control subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in the relative abundance of prioritized transcripts measured in CSF in the PD group compared to the healthy control group.
Measured: Enrollment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Clemens Scherzer, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867788
- Sponsor's protocol ID
- NS082157
- Other IDs
- U01NS082157
- Acronym
- HBS2
- Status last verified
- Jan 2016
- First submitted
- 30 May 2013
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ancillary Longitudinal CSF Collection Study in the Harvard Biomarker Study - HBS2
- ClinicalTrials.gov ID
- NCT01867788
- Acronym / sponsor ID
- HBS2 / NS082157
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Harvard Medical School (HMS and HSDM)
- Study start
- Sep 2012
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease subjects | – | – |
| Healthy Control subjects | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two tertiary care centers.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- Acquired or inherited bleeding disorders
- Hematologic malignancies
- Hematocrit < 30
- Active ulcer or active colitis
- Known pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.