Parkinson's DiseaseNCT02761707
Biomarkers in Neural Disorders
An observational study of Parkinson's Disease and Alzheimer's Disease, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Alzheimer's Disease, Progressive Supranuclear Palsy
- What is being tested?
- Electrical Brainstem Responses, Olfactory Tests and Visual Deprivation
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 16 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Parkinson's Disease, Alzheimer's Disease, Progressive Supranuclear Palsy, Essential Tremor, Multiple System Atrophy, Drug Induced Parkinson's Disease
- Being tested
- Electrical Brainstem Responses, Olfactory Tests, Visual Deprivation, Peripheral Nerve Stimulation
- Medical subject headings
- Parkinson Disease, Alzheimer Disease, Supranuclear Palsy, Progressive, Essential Tremor, Multiple System Atrophy, Lewy Body Disease, Myasthenia Gravis, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Brainstem ResponsesOther
Also called Electromyography
Eye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG). The subjects will recline with their eyes gently closed. Sticky electrodes will be placed to the left and below the left eye. 6 different facial regions will be stimulated. The electrical stimulation will be kept constant during the test sessions. To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec. Four 0.2 msec pulses will be presented. In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec. 4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences.
Olfactory TestsOther
Olfactory testing will be performed using standard tests. The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format. The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol. Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test. This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected.
Visual DeprivationOther
During a 2-hour visual deprivation period, subjects will wear comfortable light-tight goggles with lenses that have been blackened by flat black paint. Subjects will be given the opportunity to recline comfortable in a padded reclining chair during this time.
Peripheral Nerve StimulationOther
Also called Repetitive Nerve Stimulation
Electrical stimulation will be applied to a nerve of your arm. Sticky electrode pads will also be placed on a hand muscle. You will receive electrical stimulations that lasts less than a second. The stimulations will make your muscle twitch.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease | Non-smokers, ages 18-80, diagnosed with Parkinson's Disease. Must be Hoehn and Yahr stage 2 or less with a history of motor symptoms less than two years. Receives: Other: Electrical Brainstem Responses; Other: Olfactory Tests; Other: Visual Deprivation; Other: Peripheral Nerve Stimulation | |
| Alzheimer's Disease | Non-smokers, ages 18-80, diagnosed with Alzheimer's Disease. Must 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. Receives: Other: Electrical Brainstem Responses; Other: Olfactory Tests; Other: Peripheral Nerve Stimulation | |
| Progressive Supranuclear Palsy | Non-smokers, ages 18-80, diagnosed with Progressive Supranuclear Palsy. Must meet 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. Receives: Other: Electrical Brainstem Responses; Other: Olfactory Tests; Other: Peripheral Nerve Stimulation | |
| Essential Tremor | Non-smokers, ages 18-80, diagnosed with Essential Tremor. Receives: Other: Electrical Brainstem Responses; Other: Olfactory Tests; Other: Peripheral Nerve Stimulation | |
| Drug-Induced Parkinson's Disease | Non-smokers, ages 18-80, diagnosed with Drug-Induced Parkinson's Disease. Receives: Other: Electrical Brainstem Responses; Other: Olfactory Tests; Other: Peripheral Nerve Stimulation | |
| Myasthenia Gravis | Non-smokers, ages 18-80, diagnosed with Myasthenia Gravis. Receives: Other: Electrical Brainstem Responses; Other: Olfactory Tests; Other: Peripheral Nerve Stimulation | |
| Multiple System Atrophy | Non-smokers, ages 18-80, who have been diagnosed with Multiple System Atrophy. Receives: Other: Electrical Brainstem Responses; Other: Olfactory Tests; Other: Peripheral Nerve Stimulation | |
| Diffuse Lewy Body Disease | Non-smokers, ages 18-80, diagnosed with Diffuse Lewy Body Disease. Must meet the Consensus Criteria for the clinical diagnosis of DLBD. Receives: Other: Electrical Brainstem Responses; Other: Olfactory Tests; Other: Peripheral Nerve Stimulation | |
| Healthy Controls | Non-smokers, ages 18-80, with no neurodegenerative disease, and no first-degree relatives with a neurodegenerative disease. Receives: Other: Electrical Brainstem Responses; Other: Olfactory Tests; Other: Visual Deprivation; Other: Peripheral Nerve Stimulation | |
| Spinal Cord Injury | Not described Receives: Other: Electrical Brainstem Responses; Other: Olfactory Tests; Other: Peripheral Nerve Stimulation | |
| Asymptomatic Relatives | Not described Receives: Other: Electrical Brainstem Responses; Other: Olfactory Tests; Other: Peripheral Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency, amplitude, and area under the curve of brainstem reflex response
Latency, amplitude, and area under the curve of electrical brainstem reflex response of trigeminal nerve branches measured on the face musculature (before and after short-term visual deprivation).
Measured: 1 Hour
Score on the University of Pennsylvania Smell Identification Test
The number of correct odor identification responses out of 40 from the standardized University of Pennsylvania Smell Identification Test (before and after short-term visual deprivation).
Measured: 20 Minutes
Score on the Odor Discrimination/Memory Test
The number of correct responses in picking out an odor previously presented from three foils 10, 30, and 60 sec later using the standardized Odor Detection/Discrimination Test (before and after short-term visual deprivation).
Measured: 30 Minutes
Score on an Odor Detection Threshold Test
The average of 7 reversals in a staircase odor detection threshold test that employs phenyl ethyl alcohol (rose oil) concentrations ranging from -7 to -2 log dilutions in light mineral oil.
Measured: 20 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
- Investigators
- Richard L Doty, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761707
- Sponsor's protocol ID
- 827731
- Status last verified
- Jul 2019
- First submitted
- 18 Apr 2016
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Neural Disorders
- ClinicalTrials.gov ID
- NCT02761707
- Acronym / sponsor ID
- 827731
- Conditions
- Parkinson's Disease, Alzheimer's Disease, Progressive Supranuclear Palsy, Essential Tremor, Multiple System Atrophy, Drug Induced Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease | – | Other: Electrical Brainstem Responses, Other: Olfactory Tests, Other: Visual Deprivation, Other: Peripheral Nerve StimulationNon-smokers, ages 18-80, diagnosed with Parkinson's Disease. Must be Hoehn and Yahr stage 2 or less with a history of motor symptoms less than two years. |
| Alzheimer's Disease | – | Other: Electrical Brainstem Responses, Other: Olfactory Tests, Other: Peripheral Nerve StimulationNon-smokers, ages 18-80, diagnosed with Alzheimer's Disease. Must 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. |
| Progressive Supranuclear Palsy | – | Other: Electrical Brainstem Responses, Other: Olfactory Tests, Other: Peripheral Nerve StimulationNon-smokers, ages 18-80, diagnosed with Progressive Supranuclear Palsy. Must meet 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. |
| Essential Tremor | – | Other: Electrical Brainstem Responses, Other: Olfactory Tests, Other: Peripheral Nerve StimulationNon-smokers, ages 18-80, diagnosed with Essential Tremor. |
| Drug-Induced Parkinson's Disease | – | Other: Electrical Brainstem Responses, Other: Olfactory Tests, Other: Peripheral Nerve StimulationNon-smokers, ages 18-80, diagnosed with Drug-Induced Parkinson's Disease. |
| Myasthenia Gravis | – | Other: Electrical Brainstem Responses, Other: Olfactory Tests, Other: Peripheral Nerve StimulationNon-smokers, ages 18-80, diagnosed with Myasthenia Gravis. |
| Multiple System Atrophy | – | Other: Electrical Brainstem Responses, Other: Olfactory Tests, Other: Peripheral Nerve StimulationNon-smokers, ages 18-80, who have been diagnosed with Multiple System Atrophy. |
| Diffuse Lewy Body Disease | – | Other: Electrical Brainstem Responses, Other: Olfactory Tests, Other: Peripheral Nerve StimulationNon-smokers, ages 18-80, diagnosed with Diffuse Lewy Body Disease. Must meet the Consensus Criteria for the clinical diagnosis of DLBD. |
| Healthy Controls | – | Other: Electrical Brainstem Responses, Other: Olfactory Tests, Other: Visual Deprivation, Other: Peripheral Nerve StimulationNon-smokers, ages 18-80, with no neurodegenerative disease, and no first-degree relatives with a neurodegenerative disease. |
| Spinal Cord Injury | – | Other: Electrical Brainstem Responses, Other: Olfactory Tests, Other: Peripheral Nerve Stimulation |
| Asymptomatic Relatives | – | Other: Electrical Brainstem Responses, Other: Olfactory Tests, Other: Peripheral Nerve Stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Brainstem ResponsesAlso: ElectromyographyEye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG). The subjects will recline with their eyes gently closed. Sticky electrodes will be placed to the left and below the left eye. 6 different facial regions will be stimulated. The electrical stimulation will be kept constant during the test sessions. To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec. Four 0.2 msec pulses will be presented. In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec. 4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences. | Other | Alzheimer's Disease, Asymptomatic Relatives, Diffuse Lewy Body Disease, Drug-Induced Parkinson's Disease, Essential Tremor, Healthy Controls, Multiple System Atrophy, Myasthenia Gravis, Parkinson's Disease, Progressive Supranuclear Palsy, Spinal Cord Injury |
| Olfactory TestsOlfactory testing will be performed using standard tests. The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format. The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol. Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test. This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected. | Other | Alzheimer's Disease, Asymptomatic Relatives, Diffuse Lewy Body Disease, Drug-Induced Parkinson's Disease, Essential Tremor, Healthy Controls, Multiple System Atrophy, Myasthenia Gravis, Parkinson's Disease, Progressive Supranuclear Palsy, Spinal Cord Injury |
| Visual DeprivationDuring a 2-hour visual deprivation period, subjects will wear comfortable light-tight goggles with lenses that have been blackened by flat black paint. Subjects will be given the opportunity to recline comfortable in a padded reclining chair during this time. | Other | Healthy Controls, Parkinson's Disease |
| Peripheral Nerve StimulationAlso: Repetitive Nerve StimulationElectrical stimulation will be applied to a nerve of your arm. Sticky electrode pads will also be placed on a hand muscle. You will receive electrical stimulations that lasts less than a second. The stimulations will make your muscle twitch. | Other | Alzheimer's Disease, Asymptomatic Relatives, Diffuse Lewy Body Disease, Drug-Induced Parkinson's Disease, Essential Tremor, Healthy Controls, Multiple System Atrophy, Myasthenia Gravis, Parkinson's Disease, Progressive Supranuclear Palsy, Spinal Cord Injury |
Primary outcome
Latency, amplitude, and area under the curve of brainstem reflex response
Time frame: 1 Hour
Latency, amplitude, and area under the curve of electrical brainstem reflex response of trigeminal nerve branches measured on the face musculature (before and after short-term visual deprivation).
Score on the University of Pennsylvania Smell Identification Test
Time frame: 20 Minutes
The number of correct odor identification responses out of 40 from the standardized University of Pennsylvania Smell Identification Test (before and after short-term visual deprivation).
Score on the Odor Discrimination/Memory Test
Time frame: 30 Minutes
The number of correct responses in picking out an odor previously presented from three foils 10, 30, and 60 sec later using the standardized Odor Detection/Discrimination Test (before and after short-term visual deprivation).
Score on an Odor Detection Threshold Test
Time frame: 20 Minutes
The average of 7 reversals in a staircase odor detection threshold test that employs phenyl ethyl alcohol (rose oil) concentrations ranging from -7 to -2 log dilutions in light mineral oil.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Parkinson's Disease
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
RecruitingPhase 2/3
A Study of Buntanetap in Participants With PD
Parkinson's Disease (PD), Deep Brain Stimulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard L Doty, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Alzheimer's Disease, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency, amplitude, and area under the curve of brainstem reflex response (time frame: 1 Hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.