Parkinson's DiseaseBioFINDNCT01705327

Fox Investigation for New Discovery of Biomarkers

An observational study of Parkinson's Disease, run by Michael J. Fox Foundation for Parkinson's Research at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an observational, multi-center study to assess clinical features and biologic biomarkers in Parkinson's disease (PD) patients compared to healthy controls (HC). The primary objective of this study is to discover clinical and biologic markers of PD for use in clinical trials of disease-modifying therapies. Read more about this study

Who is it for?: Ages 55 to 93 yearsHealthy volunteers can take part
Conditions the study is for: Parkinson's Disease
How many people: 240 participants
Where: 7 sitesUnited States
Study dates: Oct 2012to Mar 2015
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 55 to 93 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Parkinson's disease and healthy control subjects

Who may be able to join

Subjects must have bradykinesia and rigidity.
Current or history of well documented resting tremor.
Unilateral onset or persistent asymmetry.
A well established response to dopaminergic agents including the presence of levodopa induced dyskinesia for at least 3 years according to treating physician's judgment.
Subject has progressive PD of 5 to 18 years of duration from the onset of symptoms.
Male or female age of onset of PD 50 to 70 by history. Current ages would range from 55 to 93 based on #5 and #6 requirements.

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Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
Willing and able to comply with scheduled visits, required study procedures and laboratory tests.
Male or female age 55 to 93 years at visit 1.
Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
Willing and able to comply with scheduled visits, required study procedures and laboratory tests.

Who cannot join

Family history of PD in first degree relatives.
Ashkenazi Jewish subject (defined as all 4 grandparents being Ashkenazi Jewish) will be excluded because of the high likelihood of genetic forms of PD (LRRK2) and GBA), unless these have been already excluded by genetic testing.
Has others serious neurological disorders (clinically significant stroke, brain tumor, hydrocephalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated head trauma).
Has early severe autonomic involvement. Symptomatic orthostatic, hypotension or urinary incontinence within one year of onset of disease symptom.
Current treatment with anticoagulants (e.g., Coumadin, heparin) that might preclude safe completion of the lumbar puncture.
Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.

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Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
Use of investigational drugs or devices within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
Has lower body predominant symptoms.
Has supra-nuclear gaze palsy, CG sign, corticospinal track signs.
Family history of PD in first degree relatives.
Ashkenazi Jewish subject (defined as all 4 grandparents being Ashkenazi Jewish) will be excluded because of the high likelihood of genetic forms of PD (LRRK2) and GBA), unless these have been already excluded by genetic testing.
Has other serious neurological disorders (clinically significant stroke, brain tumor, hydrocephalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated head trauma).
Has a history of cancer, autoimmune disorder, liver disease, or hematological disorders within the past 5 years.
Has early severe autonomic involvement: symptomatic orthostatic hypotension or urinary incontinence within one year of onset of disease symptom.
Current treatment with anticoagulants (e.g., Coumadin, heparin) that might preclude safe completion of the lumbar puncture.
Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
Use of investigational drugs or devices within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
MoCA score <26.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35233
Rush University Medical Center
Chicago, Illinois
University of Chicago
Chicago, Illinois
University of Minnesota
Minneapolis, Minnesota
Columbia University Medical Center
New York, New York
Cornell University Medical Center
New York, New York
Oregon Health & Science University
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Fox Investigation for New Discovery of Biomarkers (BioFIND)

Read the detailed description

BioFIND is a two-year observational clinical study designed to discover and verify biomarkers of Parkinson's disease (PD). BioFIND is collecting clinical data and biospecimens, including blood and cerebrospinal fluid (CSF), in a population of 120 well-defined, moderately advanced PD subjects and 120 healthy controls.

BioFIND will follow standardized data acquisition protocols to ensure that tests and assessments conducted at multiple sites can be pooled. Data and samples acquired from study participants will enable the development of a comprehensive Parkinson's database and biorepository, which will be available to the scientific community to conduct research on novel PD biomarkers.

Conditions: Parkinson's Disease
Keywords: Parkinson's, Biomarkers, Neurodegenerative disorder
Medical subject headings: Parkinson Disease, Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01705327
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.

No primary outcome measure
Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Mar 2015

First posted12 Oct 2012 (estimated)
Study startOct 2012
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
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: Cohort
Time perspective: Cross-sectional
Enrolment: 240 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01705327
Sponsor's protocol ID: BioFIND
Acronym: BioFIND
Status last verified: Dec 2013
First submitted: 9 Oct 2012
Last updated: 5 Oct 2015
Results posted: No
Data monitoring committee: No

Publications

Paslawski W, Svenningsson P. Elevated ApoE, ApoJ and lipoprotein-bound alpha-synuclein levels in cerebrospinal fluid from Parkinson's disease patients - Validation in the BioFIND cohort. Parkinsonism Relat Disord. 2023 Nov;116:105765. doi: 10.1016/j.parkreldis.2023.105765. Epub 2023 Jul 12.
PubMed 37479568

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
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Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
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Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fox Investigation for New Discovery of Biomarkers (BioFIND)
ClinicalTrials.gov ID: NCT01705327
Acronym / sponsor ID: BioFIND / BioFIND
Conditions: Parkinson's Disease
Keywords: Parkinson's, Biomarkers, Neurodegenerative disorder
Study type: Observational
Recruitment status: Completed
Enrolment: 240 participants (estimated)
Lead sponsor: Michael J. Fox Foundation for Parkinson's ResearchUniversity, hospital or other
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Study start: Oct 2012
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 12 Oct 2012 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Parkinson's Disease Subjects	–	–
Healthy Control Subjects	–	–

Who may qualify

Ages: 55 to 93 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Parkinson's disease and healthy control subjects

Key inclusion criteria (11 listed)

Subjects must have bradykinesia and rigidity.
Current or history of well documented resting tremor.
Unilateral onset or persistent asymmetry.
A well established response to dopaminergic agents including the presence of levodopa induced dyskinesia for at least 3 years according to treating physician's judgment.
Subject has progressive PD of 5 to 18 years of duration from the onset of symptoms.

Key exclusion criteria (20 listed)

Family history of PD in first degree relatives.
Ashkenazi Jewish subject (defined as all 4 grandparents being Ashkenazi Jewish) will be excluded because of the high likelihood of genetic forms of PD (LRRK2) and GBA), unless these have been already excluded by genetic testing.
Has others serious neurological disorders (clinically significant stroke, brain tumor, hydrocephalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated head trauma).
Has early severe autonomic involvement. Symptomatic orthostatic, hypotension or urinary incontinence within one year of onset of disease symptom.
Current treatment with anticoagulants (e.g., Coumadin, heparin) that might preclude safe completion of the lumbar puncture.

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

No primary outcome measure
Time frame: Two years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
Derived from this study: PubMed 37479568Paslawski W, Svenningsson P. Elevated ApoE, ApoJ and lipoprotein-bound alpha-synuclein levels in cerebrospinal fluid from Parkinson's disease patients - Validation in the BioFIND cohort. Parkinsonism Relat Disord. 2023 Nov;116:105765. doi: 10.1016/j.parkreldis.2023.105765. Epub 2023 Jul 12.

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

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.

Jennifer Goldman, MD, MS principal investigator

Rush University Medical Center

Roy Alcalay, MD, MS principal investigator

Columbia University

Claire Henchcliffe, MD, D. Phil principal investigator

Well Cornell Medical Center

7 sites 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 Michael J. Fox Foundation for Parkinson's Research at 7 sites 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 11 inclusion and 20 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: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

No primary outcome measure (time frame: Two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01705327, which also lists 1 linked publication.

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 5 Oct 2015.