Identifying Biomarkers of Parkinson's Disease Using Magnetic Resonance Imaging (MRI)

NCT01888185 | Completed

• 1 other identifier: MSHersheyMC-40726
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine if magnetic resonance imaging (MRI) measures can be used to diagnose and monitor the progression of Parkinson's disease (PD) while distinguishing between PD and parkinsonisms \[conditions that are PD look-a-like diseases such as progressive supranuclear palsy (PSP) or multiple system atrophy (MSA)\] when combined with changes in certain proteins in body fluids that are related to iron (Fe).

Conditions

Parkinson's Disease (PD); Parkinsonism; Progressive Supranuclear Palsy (PSP); Multiple System Atrophy (MSA)

Keywords

Parkinson's; PD; nigrostriatal; substantia nigra; MRI; DTI; FA; R2*; Parkinson's Disease Biomarkers Program; PDBP; ferritin; transferrin; Fe; iron protein; PSP; MSA

Outcome Measures

Primary Outcomes (1)

• Differential roles of fractional anisotropy (FA) and R2* in PD detection and progression

  Substantia Nigra (SN) FA and R2\* values in PD subjects will be compared with control subjects and correlated with clinical and behavioral measures.

  Change in roles of FA and R2* assessed between baseline and 18 months. Change assessed between baseline and 36 months. Change assessed between 18 and 36 months.

Secondary Outcomes (3)

• Nigrostriatal diffusion tensor imaging (DTI) and R2* differentiate PD from parkinsonian syndromes

  Assessed at baseline visit.

• Iron(Fe)-related proteins in body fluids as biomarkers of PD

  Change assessed between baseline and 18 months. Change assessed between baseline and 36 months. Change assessed between 18 and 36 months.

• MRI and postmortem pathological correlation

  From baseline until date of death from any cause within 5 years for patient participants who succumb to their disease

Study Arms (4)

Parkinson's Disease (PD)

Patients with a clinical diagnosis of PD (in various stages)

Progressive supranuclear palsy (PSP)

Patients with a clinical diagnosis of PSP (in various stages)

Multiple system atrophy (MSA)

Patients with a clinical diagnosis of MSA (in various stages)

Controls

Age and gender-matched adults free from neurological disease

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinical patients and community volunteers

You may qualify if:

• PD Subjects:
• Able and willing to sign the consent form at time of initial enrollment or if the subject is decisionally impaired and has a legal representative that is able and willing to sign a consent form at the time of the enrollment. If the subject becomes decisionally impaired during the course of the study, their legal representative may sign an addendum to consent for continued participation.
• MMSE score of 15 or greater unless a legal representative is present.
• Idiopathic PD according to published criteria.
• History of adequate response to dopaminergic therapy.
• History of asymmetrical symptom onset
• MSA Subjects:
• Older than 30 yrs.
• Able and willing to sign the consent form at time of initial enrollment or if the subject is decisionally impaired and has a legal representative that is able and willing to sign a consent form at the time of the enrollment. If the subject becomes decisionally impaired during the course of the study, their legal representative may sign an addendum to consent for continued participation.
• MMSE score of 15 or greater unless a legal representative is present.
• MSA according to published criteria.
• History of autonomic \& urinary dysfunction and/or severe cerebellar ataxia.
• PSP Subjects:
• Older than 40 yrs.
• Able and willing to sign the consent form at time of initial enrollment or if the subject is decisionally impaired and has a legal representative that is able and willing to sign a consent form at the time of the enrollment. If the subject becomes decisionally impaired during the course of the study, their legal representative may sign an addendum to consent for continued participation.

You may not qualify if:

• PD Subjects:
• Unable or does not have a legal representative/unwilling to provide consent.
• Any condition that precludes a routine MRI (e.g., claustrophobia, pacemaker, severe scoliosis, etc.).
• History of cerebrovascular diseases or other neurological disorders.
• Major medical problems such as renal or liver failure.
• Unstable, non-PD-related medical conditions.
• MMSE score less than 15 unless a legal representative is present
• Use of anticoagulant medications.
• Signs of dementia.
• MSA Subjects:
• Unable or does not have a legal representative /unwilling to provide consent.
• Any condition that precludes a routine MRI (e.g., claustrophobia, pacemaker, severe scoliosis, etc.).
• History of cerebrovascular diseases or other neurological disorders.
• Major medical problems such as renal or liver failure.
• Unstable, non-MSA-related medical conditions.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center and College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Links

• Parkinson's Disease Biomarkers Program (PDBP) description of study
• Penn State Hershey Neurology homepage

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma, white blood cells, urine, cerebral spinal fluid (CSF), tissue

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Supranuclear Palsy, Progressive; Multiple System Atrophy

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Primary Dysautonomias; Autonomic Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xuemei Huang, M.D., Ph.D.

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: June 27, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: January 3, 2020

Record last verified: 2020-01

Locations

US (1)