Advertisement

Topics

Biological Markers in Parkinson's Disease

2014-08-27 03:54:11 | BioPortfolio

Summary

This study will identify abnormalities of a protein called alpha synuclein that is found in the brain of patients with Parkinson's disease and related disorders to see if it can serve as a disease marker. There is currently no treatment that will cure or delay progression of Parkinson's disease. Thus, there is a need to find disease markers that can help diagnosis the disease, follow its progression, and monitor the effects of treatment. This study will examine and compare alpha synuclein from blood and cerebrospinal fluid (the fluid that bathes the brain and spinal cord) of patients with Parkinson's disease, patients with variants of the disease, and healthy normal volunteers to determine differences in the protein that might serve as a disease marker.

Patients with neurodegenerative disorders such as Parkinson's disease and Parkinson plus disorders (other diseases that are variants of Parkinson's disease) and healthy volunteers between 18 and 80 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, neurological evaluation, and blood tests. A brain MRI (magnetic resonance imaging) scan is done if needed for diagnosis.

All participants have a blood sample drawn and a lumbar puncture (spinal tap). For the lumbar puncture, a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. The fluid is analyzed for specific proteins and chemicals that are leaked from the brain in various disease states and that cannot be measured in blood.

Participation of healthy volunteers is completed after the blood draw and lumbar puncture. Patients with Parkinson's and related diseases return to the clinic once a year for 2 years for a repeat blood draw and lumbar puncture to follow changes in the alpha synuclein protein and to monitor disease progression. Patients with specific proteins of interest may also be asked to come for a repeat lumbar puncture 6 months after the first procedure.

Description

OBJECTIVE: Parkinson's disease (PD) is a progressive neurodegenerative disorder of unknown etiology in which several underlying pathophysiological mechanisms including proteasomal degradation, mitochondrial dysfunction, inflammation, oxidative stress, and excitotoxicity may contribute to cell death. No treatment is known to cure or delay progression of PD, thus there is a need to investigate measurable biologic markers for the purpose of diagnosis, monitoring disease progression and effect of treatment. This study will focus on alpha synuclein and its metabolic pathways as a potential biomarker, to assist in evaluation of pathogenesis and future diagnostic and therapeutic options.

STUDY POPULATION: In this pilot study we plan to include 30 patients with Parkinson's disease (PD), 30 patients with Parkinson plus disorders, and 30 control patients without neurologic disease or autoimmune disorders.

DESIGN: Samples of serum, plasma and cerebrospinal fluid (CSF) will be collected from all patients for analysis at the beginning of the study. The assay will be performed for various proteins including cytokines primarily related to the alpha synuclein (AS) pathway. A repeat CSF, plasma and serum analysis will be performed in patients with PD, and Parkinson plus disorders at the end of one and two years to follow changes of protein expression profiles with disease progression.

ASSESSMENT OF RISKS AND BENEFITS: This study will carry the risk associated with venepuncture and lumbar puncture.

OUTCOME ESTIMATE AND POTENTIAL MEANING FOR THE FIELD: The primary outcome measure is to correlate the changes of alpha synuclein phosphorylation in CSF, plasma and serum with changes in UPDRS motor score in patients with PD over the period of 2 years, compared to controls. The secondary aim of the study is to compare the protein expression profiles between different synucleinopathies including PD, Multiple System Atrophy (MSA) and Dementia with Lewy Bodies (DLB) with time. There are currently no validated surrogate disease markers in PD or other related neurodegenerative disorders. Our work would hopefully help understand pathophysiologic mechanisms in patients with PD, monitor disease progression using specific biologic markers, and in future development of targeted therapies.

Study Design

N/A

Conditions

Parkinson Disease

Location

National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda
Maryland
United States
20892

Status

Completed

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:11-0400

Clinical Trials [1176 Associated Clinical Trials listed on BioPortfolio]

The Parkinson's Disease NeuroGenebank at Scripps Clinic Registry

By creating a neurogenebank from Parkinson's disease patients' blood donations we will ultimately be able to define genes for Parkinson's disease and other neurological conditions.

Parkinson's Repository of Biosamples and Network Datasets (Tracking Parkinson's)

Prospective observational study of Parkinson's disease with repeat clinical assessment and biobanking of blood samples.

A Mobile Application for Telerehabilitation in Parkinson's Disease

The purpose of this study is to determine if the 9zest app for Parkinson's disease is feasible, safe, and efficacious when used independently by individuals with Parkinson's disease.

Ultra High Field Magnetic Resonance Imaging as a Biomarker for Premotor Parkinson's Disease

This is a prospective observational study investigating the utility of 7 Tesla MRI to quantify nigrosome1 signal in a cohort of individuals with recent onset Parkinson's disease and in at-...

Molecular Epidemiology of Parkinson's Disease

The aim of this research is to discover genes which modify risk for Parkinson's disease. The study includes 800 patients with Parkinson's disease, and their estimated 1,222 available sibli...

PubMed Articles [14919 Associated PubMed Articles listed on BioPortfolio]

Qualitative Evaluation of the Personal KinetiGraphTM Movement Recording System in a Parkinson's Clinic.

Wearable-sensors provide accurate, continuous objective measurements, quantifying the variable motor states of patients with Parkinson's disease (PD) in real time.

A Comparison of Pain between Parkinson's Disease and Multiple System Atrophy: A Clinical Cross-Sectional Survey.

Pain is frequent in Parkinson's disease (PD) and Parkinson-plus syndrome. This study aimed to assess the prevalence, characteristics, therapy (especially the effect of dopaminergic therapy), and assoc...

Mobilizing Parkinson's Disease: The Future of Exercise.

Exercise is increasingly recognized as an important element in the treatment of Parkinson's disease but what is exercise targeting? What accounts for the benefits observed in Parkinson's disease? Is e...

The Emerging Evidence of the Parkinson Pandemic.

Neurological disorders are now the leading source of disability globally, and the fastest growing neurological disorder in the world is Parkinson disease. From 1990 to 2015, the number of people with ...

Easing Burden and Stress: Intervention Needs of Family Members of Patients with Parkinson's Disease.

Despite a growing research literature on caregiver burden in progressive diseases (e.g., dementia), the experiences and needs of family members of patients with Parkinson's disease (PD), especially of...

Medical and Biotech [MESH] Definitions

Proteins associated with sporadic or familial cases of PARKINSON DISEASE.

A condition caused by the neurotoxin MPTP which causes selective destruction of nigrostriatal dopaminergic neurons. Clinical features include irreversible parkinsonian signs including rigidity and bradykinesia (PARKINSON DISEASE, SECONDARY). MPTP toxicity is also used as an animal model for the study of PARKINSON DISEASE. (Adams et al., Principles of Neurology, 6th ed, p1072; Neurology 1986 Feb;36(2):250-8)

A group of disorders which feature impaired motor control characterized by bradykinesia, MUSCLE RIGIDITY; TREMOR; and postural instability. Parkinsonian diseases are generally divided into primary parkinsonism (see PARKINSON DISEASE), secondary parkinsonism (see PARKINSON DISEASE, SECONDARY) and inherited forms. These conditions are associated with dysfunction of dopaminergic or closely related motor integration neuronal pathways in the BASAL GANGLIA.

Parkinsonism following encephalitis, historically seen as a sequella of encephalitis lethargica (Von Economo Encephalitis). The early age of onset, the rapid progression of symptoms followed by stabilization, and the presence of a variety of other neurological disorders (e.g., sociopathic behavior; TICS; MUSCLE SPASMS; oculogyric crises; hyperphagia; and bizarre movements) distinguish this condition from primary PARKINSON DISEASE. Pathologic features include neuronal loss and gliosis concentrated in the MESENCEPHALON; SUBTHALAMUS; and HYPOTHALAMUS. (From Adams et al., Principles of Neurology, 6th ed, p754)

Conditions which feature clinical manifestations resembling primary Parkinson disease that are caused by a known or suspected condition. Examples include parkinsonism caused by vascular injury, drugs, trauma, toxin exposure, neoplasms, infections and degenerative or hereditary conditions. Clinical features may include bradykinesia, rigidity, parkinsonian gait, and masked facies. In general, tremor is less prominent in secondary parkinsonism than in the primary form. (From Joynt, Clinical Neurology, 1998, Ch38, pp39-42)

More From BioPortfolio on "Biological Markers in Parkinson's Disease"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...


Searches Linking to this Trial