Clinical trial NCT02761707: Biomarkers in Neural Disorders
Official title: Biomarkers in Neural Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2016-05-04
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal controls and patients with such neural disorders as Parkinson's Disease(PD), Alzheimer's disease (AD), progressive supranuclear palsy (PSP), essential tremor (ET), dementia with Parkinson's disease (D-PD), myasthenia gravis (MG), multiple system atrophy (MSA), diffuse Lewy body disease (DLBD), and Spinal Cord Injury (SCI). None will be cigarette smokers. The patients will be diagnosed accord to current consensus criteria. The healthy controls will be matched to the PD patients on such variables as sex, age, education level, and ethnicity. The Healthy Controls will be asked to answer questions regarding the disease state of their first degree family members to ensure that these first degree family members do not have a neurodegenerative diseases. Every effort will be made to include women and minority subjects.

Brief summary: 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.

Detailed description: Parkinson's disease (PD), a devastating age-related disease that is clinically defined by its effects on the motor system, afflicts more than six million people worldwide, imposing enormous burdens on patients, relatives, caretakers, and society in general. Diagnostic errors are common, particularly as symptoms first arise. The most common misdiagnoses are Alzheimer's disease (AD), essential tremor, and vascular pseudo-Parkinson's Disease. An accurate diagnosis is typically made at a later stage of the disease when marked and irreversible damage has occurred within the motor control system of the brain. Sensitive and specific biomarkers of the early stages of PD are urgently needed. Identification of such markers is critical for the development and assessment of medications and other interventions designed to eliminate or reduce the gradual and irreversible decline of neurons involved in the disorder. This study seeks to establish the sensitivity and specificity of what appears to be a unique brainstem biomarker of PD - an electrically induced trigeminal nerve blink reflex response - in differentiation of early stage PD from normal controls and such neurodegenerative diseases as early stage AD, progressive supranuclear palsy (PSP), and diffuse Lewy Body disease (DLBD). This study will additionally compare the biomarker to olfactory test results.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Latency, amplitude, and area under the curve of brainstem reflex response
timeFrame: 1 Hour
measure: Score on the University of Pennsylvania Smell Identification Test
timeFrame: 20 Minutes
measure: Score on the Odor Discrimination/Memory Test
timeFrame: 30 Minutes
measure: Score on an Odor Detection Threshold Test
timeFrame: 20 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Richard L Doty, PhD
role: PRINCIPAL_INVESTIGATOR
References: