Biomarkers in Neural Disorders

Completed

Conditions studied: Parkinson's Disease, Alzheimer's Disease, Progressive Supranuclear Palsy, Essential Tremor, Multiple System Atrophy, Drug Induced Parkinson's Disease, Diffuse Lewy Body Disease, Myasthenia Gravis, Spinal Cord Injuries

In brief

This study seeks to establish the sensitivity and specificity of what appears to be a unique brainstem biomarker of Parkinson's Disease (PD) - an electrically induced olygosynaptic nasotrigeminal reflex response - in differentiating early stage PD from normal controls and from patients with various other neurodegenerative diseases. This study will additionally compare the biomarker to olfactory testing.

Key facts

Study ID

NCT02761707

Run by

University of Pennsylvania

People needed

54

Starts

2016-06-01

Expected to finish

2019-07-16

Last updated by the study team

2019-07-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The Parkinson's disease (PD) patients will be Hoehn and Yahr stage 2 or less with a history of motor symptoms less than two years.
• The Alzheimer's disease (AD) patients will meet the 2011 National Institute on Aging-Alzheimer's Association and the 1984 National Institute for Neurological and Communicative Disorders and Stroke-Alzheimer's disease and Related Disorders Association criteria for probable AD.
• The progressive supranuclear palsy (PSP) patients will have met the NINDS-SPSP criteria for probable PSP, which requires vertical supranuclear gaze palsy, prominent postural instability, and falls in the first year of onset, as well as a number of other clinical features.
• The DLBD patients will meet the Consensus Criteria for the clinical diagnosis of DLBD.
• The healthy controls will be matched to the PD patients on such variables as sex, age, education level, and ethnicity.
• The essential tremor (ET), multiple system atrophy (MSA), myasthenia gravis (MG), multiple system atrophy (MSA), Parkinson's disease dementia (D-PD), and Spinal Cord Injury (SCI) patients will meet the generally-accepted diagnostic criteria for these disorders.

You may not qualify if…

• Drug abuse.
• Any other known and potentially confounding condition that could reasonably be expected to interfere with the study assessments.
• Under age 18.
• Over age 80.
• Smoker.
• Pregnant or nursing.
• Healthy control with a first degree relative who has a neurodegenerative disease.

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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