Biospecimens

The MJFF-sponsored Parkinson's Progression Markers Initiative (PPMI) has built the most robust library of clinical and imaging data and biosamples in the history of Parkinson’s research. PPMI follows volunteers for at least five years.

Study subjects:

• 423 de novo idiopathic PD patients; 196 healthy controls; 64 subjects with scans without evidence of dopaminergic deficit (SWEDDs)
• 65 subjects with Parkinson's risk factors of hyposmia or REM sleep behavior disorder
• 372 LRRK2 mutation carriers; 246 GBA mutation carriers; 27 SNCA mutation carriers (PD and unaffected)

Available data:

All data are de-identified.

• Clinical: motor, non-motor (cognitive, neurobehavioral, neuropsychological, autonomic, olfaction, sleep)
• Imaging: fMRI, DaTSCAN SPECT, DTI, AV-133
• Biologic: e.g. spinal fluid alpha-synuclein, amyloid-beta, tau, phosphorylated tau levels
• Genetic: SNP genotyping, whole exome sequencing, whole genome sequencing data, transcriptomics, DNA methylation

Available biospecimens: urine, plasma, serum, whole blood, cerebrospinal fluid, peripheral mononuclear blood cells, DNA and RNA from blood; fibroblasts and induced pluripotent stem cells from a subset of PPMI participants

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The Fox Investigation for New Discovery of Biomarkers (BioFIND) is a cross-sectional study sponsored by MJFF with support from the National Institute of Neurological Disorders and Stroke (NINDS). Clinical data and biological specimens were collected at 8 sites across the United States. Biospecimen collection was performed at baseline and samples were drawn within 1-3 hours of most recent PD medication administration. Biospecimens collected when subjects were off their PD medications are available from a single follow-up visit 14 days later.

Study subjects:

• 122 well-defined, moderately advanced PD patients and 101 healthy controls

Available data:

All data are de-identified.

• Clinical: motor, non-motor (cognitive, neurobehavioral, neuropsychological, autonomic, sleep)
• Biologic: e.g. spinal fluid alpha-synuclein, amyloid-beta, tau, phosphorylated tau levels
• Genetic: SNP genotyping

Available biospecimens: plasma, DNA and RNA from blood, whole blood pellet, cerebrospinal fluid, urine, saliva

Learn more:
Download data

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See Available Genetic Mutations

Study Documents:

• Study Protocol
• Schedule of Activities
• Case Report Forms
• Operations Manual
• Laboratory Manual
• Data Use Agreement
• Biospecimens Use Agreement
• Publications Policy

The LRRK2 Cohort Consortium (LCC) comprises three closed studies that followed standardized data acquisition protocols. Clinical data and biological samples are stored in a comprehensive Parkinson's database and biorepository. The LCC was an international multi-site effort to study individuals with idiopathic PD, healthy controls, LRRK2 mutation-positive PD patients, and LRRK2 mutation-positive controls. The LCC was intended to provide a resource for the study of novel PD biomarkers with the goal of addressing the relevance of the LRRK2 genetic pathway.

All data and biospecimens are de-identified.

LRRK2 Cross-sectional Study

Study subjects:

• 797 idiopathic PD; 508 controls
• 823 LRRK2+ PD patients (mainly G2019S); 722 LRRK2+ carriers without PD (mainly G2019S)

Available data:

• Clinical: motor, non-motor (cognitive, neurobehavioral, neuropsychological, autonomic, sleep)
• Imaging: fMRI, DaTSCAN SPECT, FDG PET, transcranial ultrasound (calculated data only; raw images not available)
• Biologic: e.g. spinal fluid alpha-synuclein, amyloid-beta, tau, phosphorylated tau levels

Available biospecimens: serum, plasma, DNA and RNA from blood, whole blood, urine and cerebrospinal fluid available from a subset of participants

Learn more:
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LRRK2 Longitudinal Study

Study subjects:

• 94 idiopathic PD patients, 84 controls
• 97 LRRK2+ PD patients (G2019S), 86 LRRK2+ carriers without PD (G2019S)

Available data:

• Clinical: motor, non-motor (cognitive, neurobehavioral, neuropsychological, autonomic, sleep)
• Imaging: fMRI, DaTSCAN SPECT, FDG PET, transcranial ultrasound (calculated data only; raw images not available)

Available biospecimens: serum, plasma, DNA and RNA from blood, whole blood, urine

Learn more:
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23andMe Blood Collection Study

Study subjects:

• 31 idiopathic PD patients, 31 controls
• 63 LRRK2+ PD patients (mainly G2019S), 227 LRRK2+ carriers without PD (mainly G2019S)

Available data:

• Demographics, limited family history
• Limited UPDRS, UPSIT
• Limited information on anti-inflammatory medications and head injury or concussion

Available biospecimens: serum, plasma, whole blood, DNA and RNA from blood

Learn more:
Download raw data
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Study Documents:

• Biospecimen Use Agreement
• Data Use Agreement
• Publications Policy
• Biologics Manual (Europe)
• Biologics Manual (US)
• Case Report Form
• LCC Investigators

The Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism (DATATOP) trial, conducted by the Parkinson Study Group in the late 1980s, studied the effect of deprenyl and tocopherol (a form of vitamin E) on the progression of early PD. Data were collected at baseline and at a follow-up visit, approximately 12 to 18 months later. 

Study subjects:

• ~800 early PD patients

Available data: measures of neurological function, severity of PD, cognition, mood

Available biospecimens: DNA from blood, cerebrospinal fluid, urine, serum, serum PK

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MJFF sponsored two assay qualification studies that collected biospecimens (cerebrospinal fluid and blood) over 24 hours at 11 different time points.

Study subjects:

• First study: 12 control volunteers (ages 43-69) who donated biospecimens at 11 time points over 24 hours on two separate occasions 10 to 14 days apart
• Second study: 12 PD patients and 8 age-matched volunteers, collected specimens at 11 time points during one 24-hour period

Available biospecimens: cerebrospinal fluid, serum, plasma, and whole blood

Learn more:

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The Arizona Parkinson’s Disease Consortium is a brain and body donation program that began in 1986 and has been enrolling healthy individuals and individuals with PD, Alzheimer's disease and other neurologic disorders who are willing to donate their brains and other organs for research.

Study subjects:

• Over 600 living subjects are enrolled in the program.
• Postmortem samples are available from over 450 subjects.

Available biospecimens: Fixed and frozen brain tissue, portmortem CSF and blood, whole body autopsy tissue

To request access to tissue from APDC, please email resources@michaeljfox.org.

A Randomized, double-blind, placebo-controlled, Phase IIa, parallel group, two-cohort study to define the safety, tolerability, clinical and exploratory biological activity of the chronic administration of Nilotinib in participants with Parkinson’s disease (NILO-PD) was conducted over a two year period at 27 sites. Patients in Cohort 1 were followed for 6 months, and specimens for PK and biomarker analysis were collected at multiple visits. The study was terminated after the conclusion of Cohort 1 because no clinically meaningful benefit or biological effect was found in patients treated with nilotinib.

Study subjects:

• 76  moderate to advanced PD patients

Available data: measures of neurological function, severity of PD, cognition and mood. All data are de-identified to protect patient privacy.

Available biospecimens: DNA, CSF, plasma, whole blood, serum, PBMCs

Learn more:
Request Biospecimens

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Study Documents:

• Study Protocol & Schedule of Activities
• Operations Manual
• Biologics Manual

The LRRK2 PBMC & Urine Biobank was an effort to establish a urine and PBMC repository at L'Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS - Barcelona) with accompanying clinical data, from a LRRK2 cohort.

Study subjects:

• 30 subjects with PD and 60 Healthy Controls
• 25 LRRK2 G2019S PD, 30 iPD, 25 LRRK2 G2019S Non-Manifesting Carriers, 60 Healthy Controls

Available data:

Demographic Data, Motor, non-motor, Medical History, Family History, Current Medication

Learn more:

Explore Biospecimens Inventory

To request access to samples from the LRRK2 PBMC & Urine Biobank, please email resources@michaeljfox.org

The Systemic Synuclein Sampling Study (S4) was a multicenter, cross-sectional, observational study sponsored by The Michael J. Fox Foundation. The primary objective of the study was to better understand the progression of Parkinson's disease (PD) by identifying the optimal biofluids and tissues for measuring the protein alpha-synuclein outside of the brain as a potential biomarker in individuals with PD. The secondary objective of the study was to create standard operating procedures for the collection and assessment of multiple tissues and biofluids to better understand alpha-synuclein’s potential as a biomarker for PD.

Study Subjects:

• 19 Early Parkinson's Disease subjects

• 20 Moderate Parkinson's Disease subjects

• 21 Advanced  Parkinson's Disease subjects

• 21 Healthy Controls

Available Data:

Demographic information, neurological history, medication history, MoCA, ADL, MDS-UPDRS, Hoehn and Yahr Stage, SCOPA-AUT, UPSIT, and imaging (DaTSCAN SPECT, digitized slide images of IHC stained tissue). All data are de-identified to protect patient privacy.

Study Documents:

Study Protocol

Biologics Manual

Operations Manual

Imaging Manual

Schedule of Activities

Study Investigators List

Publications Policy

Biospecimen Use Agreement

Data Use Agreement

Learn More:

Explore Biospecimens Inventory

To request access to S4 samples, please email resources@michaeljfox.org.

The STEADY-PDIII study was conducted to establish efficacy of isradipine to slow progression of Parkin-son disease (PD) disability as determined by the change in the total (Part I-III) Unified Parkinson Disease Rating Scale (UPDRS) score.

Study Subjects:

366 subjects with early idiopathic PD not requiring dopaminergic therapy

Available Data:

Measures of neurological function, severity of PD, cognition, and mood. All data are de-identified to protect patient privacy.

Learn More:

• Explore Biospecimens Inventory
• Data Repository
• Request Biospecimens

The Study of Urate Elevation in Parkinson's Disease, Phase 3 (SURE-PD3) was intended to be a two year, placebo-controlled, double-blinded trial of oral inosine treatment in individuals with PD. This trial was concluded early due to lack of effect of the treatment on the primary outcome measure of disease progression. Specimens were collected for plasma over several visits: at baseline, after up to 24 months of treatment, and 3 months (of washout) later.

Available Data:

Measures of neurological function, severity of PD, cognition, and mood. All data are de-identified to protect patient privacy.

Learn more:

• Explore Biospecimens Inventory
• Data Repository
• Request Biospecimens

The Safety of Urate Elevation in Parkinson’s Disease (SURE-PD2) trial, conducted by the Parkinson's Study Group, was a phase II placebo-controlled dose-ranging trial of oral inosine to examine the safety and impact of elevated urate levels in individuals with early PD. Biospecimens were collected at baseline, week 12 (CSF), month 6, and month 18 follow up. This trial enrolled 75 individuals with early PD.

Available Data:

Measures of neurological function, severity of PD, cognition, and mood. All data are de-identified to protect patient privacy.

Learn More:

• Explore Biospecimens Inventory
• Data Repository
• Request Biospecimens

The Parkinson Associated Risk Study (PARS) was designed to evaluate risk for developing Parkinson's disease. More specifically, PARS was designed to develop a battery of tests that can be used to reliably predict an individual risk of developing PD. Subjects have been followed over ten years.

Study Subjects:

• 301 individuals over 50 years old without a diagnosis of PD or other neurological disorder at enrollment

Available Data:

Measures of neurological function, severity of PD, cognition, and mood. All data are de-identified to protect patient privacy.

To request access to samples from PARS, please email resources@michaeljfox.org

Learn more:

• Study Website
• Explore Biospecimens Inventory
• Data Repository

The Pioglitazone in Early Parkinson's Disease (FS-ZONE) trial, conducted by the University of Rochester, was a phase II placebo-controlled study of the safety and effect of two dosages of oral pioglitazone, a drug approved for the treatment of diabetes, in patients with recently diagnosed PD. Biospecimens were collected at Baseline, 16 weeks and 44 weeks follow-up.

Study Subjects:

• 217 individuals with early PD

Available Data:

Measures of neurological function, severity of PD, cognition, and mood. All data are de-identified to protect patient privacy. FS-Zone data is available through the NIH Exploratory Trials in Parkinson’s Disease (NET-PD).

Learn more:

• Study Website
• Explore Biospecimens Inventory
• Data Repository
• Request Biospecimens

The CERE-120 studies were Phase 1/2 Trials Assessing the Safety and Efficacy of Bilateral Intraputaminal and Intranigral Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) in Subjects with Idiopathic Parkinson’s Disease. These trials were multicenter, randomized, double-blind, and sham surgery controlled. Specimens are available from CERE-120-01, CERE-120-03, and CERE-120-09.

Specimens were collected at multiple visits.

Study Subjects:

• CERE-120-01: 12 individuals with Parkinson's Disease

• CERE-120-03: 62 individuals with Parkinson's Disease

• CERE-120-09: 74 individuals with Parkinson's Disease

Available Data:

Limited clinical data are available from these trials

Learn more:

• Explore Biospecimens Inventory
• Request Biospecimens

The Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients with Parkinson’s Disease was an MJFF funded study in collaboration with Sanofi. This Phase 1b trial of Sanofi's PDE4 inhibitor (for the treatment of cognitive impairment in Alzheimer's patients) was terminated before recruitment was complete. Specimens are available from Cohort 1 (single dose) and Cohort 2 (ascending dose).

Specimens were collected at multiple visits and time-points over a 30-day period.

Study Subjects:

• 13 individuals with Parkinson's Disease

Available Data:

Measures of neurological function/severity of PD and demographics are available, but clinical information is limited.

Learn more:

• Explore Biospecimens Inventory
• Request Biospecimens