Parkinson's DiseaseNCT03648905
Clinical Laboratory Evaluation of Chronic Autonomic Failure
An observational study of Parkinson's Disease and Multiple System Atrophy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: The autonomic nervous system controls automatic body functions. Researchers want to improve the tests used to diagnose autonomic failure. Orthostatic hypertension is a drop in blood pressure when a person stands up. Researchers want to focus on this sign of autonomic failure. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Parkinson's Disease, Multiple System Atrophy, Autonomic Failure
- What is being tested?
- 13N-Ammonia, 18F-DOPA and 11C-Methylreboxetine (11C-MRB)
- Type of treatment
- Injection or infusion
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2018to 15 Jul 2026
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients with neurodegenerative CAF and patients with MSA. Comparison groups include control patients with iatrogenic CAF, patients with PD without OH (PD No OH), and Healthy Volunteers (HVs).
Who may be able to join
- Inclusion Critieria: Patients referred for orthostatic hypotension. This is the main subject cohort.
- Previously studied and diagnosed with one of the forms of nOH or else newly accrued with a referral diagnosis of orthostatic hypotension, and
- 18 years or older, and
- Able to provide own consent to participate or have an existing Legally Authorized Representative (LAR).
- If a patient has already been diagnosed as having neurodegenerative CAF under NIH Clinical Protocol 03-N-0004, this satisfies the inclusion criteria for that patient. Previous enrollment in NIH Clinical Protocol 03-N-0004 is not required for enrollment in this study. We do plan to recruit participation into this study from NIH Clinical Protocol 03-N-0004, which has been closed.
- If a patient has been referred for OH, then the patient gives consent at the NIH Clinical Center (and therefore is accrued) and then has screening testing at the NIH Clinical Center to confirm that the OH is neurogenic. We anticipate that all patients referred for OH will be shown to have nOH upon screening testing at the NIH Clinical Center. At the time of screening, exclusionary abnormal laboratory test results (e.g., high serum creatinine indicating renal failure) may come to light, in which case they will be withdrawn from the study; however, the patient would have been accrued.
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- Patients with heart transplants or pre- or post-bilateral endoscopic thoracic sympathectomies, and
- 18 years or older, and
- Able to provide own consent to participate.
- Patients with PD and no OH who have (a) already been evaluated under other protocols of the AMS and are undergoing follow-up; (b) have already been evaluated under another intramural NINDS protocol; or (c) have cardiac symptoms, signs, or laboratory findings that in the opinion of the PI make it likely there is a cardiac sympathetic lesion, and
- 18 years or older, and
- Able to provide own consent to participate.
- Age 18 years or older, and
- Able to provide own consent to participate.
- NIH employees may participate. There is no direct solicitation of employees/staff by supervisors. Co-workers will not solicit co-workers. NIH employees are required to abide by NIH Policy Manual 2300-630-3, "Leave Policy for NIH Employees Participating in NIH Medical Research Studies."
Who cannot join
- Patient Group Referred for Orthostatic Hypotension
- A medical condition that in the judgment of the Principal Investigator would place the subject at substantially increased acute medical risk, or
- A disqualifying condition such as: hepatic or renal failure, symptomatic congestive heart failure, severe anemia, psychosis, refractory ventricular arrhythmias, currently symptomatic coronary heart disease, cerebrovascular disease with current symptoms (e.g., recent transient ischemic attacks), diabetes, or
- Secondary form of CAF, such as diabetic autonomic neuropathy, or
- Being treated currently (within 2 weeks of anticipated protocol participation) with a medication known to interfere with the cell membrane norepinephrine transporter, which would obviate obtaining scientifically valid results (e.g., tricyclic antidepressant).
- Condition that may cause difficulty or inability to insert a catheter into a vein, or
Show all 34Show fewer
- Unable to tolerate lying still for up to 1 hour during the procedures, or
- Refusal to undergo certain procedures. These include: (1) IV catheter and blood drawing; (2) DNA extraction, storage, and analysis; (3) PET scanning; or
- Unable to travel safely to the NIH CC, or
- Lacking consent capacity, unless a Durable Power of Attorney (DPA) is in place, or
- Pregnant or breast feeding, or
- Subordinates of study investigators or relatives of the PI or AIs.
- Patient Control Group with Iatrogenic CAF or PD No OH
- A medical condition which in the judgment of the Principal Investigator would place the subject at substantially increased acute medical risk, or
- A disqualifying condition such as: hepatic or renal failure, symptomatic congestive heart failure, severe anemia, psychosis, refractory ventricular arrhythmias, currently symptomatic coronary heart disease, cerebrovascular disease with current symptoms (e.g., recent transient ischemic attacks), or diabetes, or
- Being treated currently (within 2 weeks of anticipated protocol participation) with a medication that would obviate obtaining scientifically valid results (e.g., tricyclic antidepressant).
- Condition that may cause difficulty or inability to insert a catheter into a vein, or
- Unable to tolerate lying still for up to 1 hour during the procedures, or
- Refusal to undergo certain procedures. These include: (1) IV catheter and (2) PET scanning, or
- Unable to travel safely to the NIH CC, or
- Lacking consent capacity, or
- Pregnant or breast feeding, or
- Subordinates of study investigators or relatives of the PI or AIs.
- Healthy Volunteer Group
- A medical condition which in the judgment of the Principal Investigator would place the subject at substantially increased acute medical risk, or
- A disqualifying condition such as: hepatic or renal failure, symptomatic congestive heart failure, severe anemia, psychosis, refractory ventricular arrhythmias, currently symptomatic coronary heart disease, cerebrovascular disease with current symptoms (e.g., recent transient ischemic attacks), diabetes, or
- Being treated currently (within 2 weeks of anticipated protocol participation) with a medication that would obviate obtaining scientifically valid results (e.g., tricyclic antidepressant).
- Condition that may cause difficulty or inability to insert a catheter into a vein, or
- Unable to tolerate lying still for up to 1 hour during the procedures, or
- Refusal to undergo certain procedures. These include: (1) IV catheter and (2) PET scanning, or
- Unable to travel safely to the NIH CC, or
- Lacking consent capacity, or
- Pregnant or breast feeding, or
- Subordinates of study investigators or relatives of the PI or AIs.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
The autonomic nervous system controls automatic body functions. Researchers want to improve the tests used to diagnose autonomic failure. Orthostatic hypertension is a drop in blood pressure when a person stands up. Researchers want to focus on this sign of autonomic failure.
Read more
Objective:
To improve testing for conditions that cause autonomic nervous system failure.
Eligibility:
People ages 18 and older in one of these categories:
- Their blood pressure drops when they get up.
- They have had a heart transplant or bilateral endoscopic thoracic sympathectomies or have had or will have renal sympathetic ablation
Design:
All participants will be screened with:
- Medical history
- Physical exam
- Blood and urine tests
Some participants will be screened with:
- Heart and breathing tests
- IV placement into an arm vein
- Tilt table testing: Participants lie on a table that tilts while an IV is used to draw their blood.
Participants may stay in the hospital for up to 1 week depending on their tests. Tests may include repeats of screening tests and:
- Sweat testing: A drug is placed on the skin to cause sweating. Sensors on the skin measure moisture.
- Lumbar puncture: A needle is inserted between the bones in the back to collect fluid.
- MRI and PET/CT scan: Participants lie on a table that slides into a scanner. For the PET/CT, a small amount of a radioactive chemical will be injected with a small amount of a radioactive chemical.
- Bladder catheter placement to collect urine
- Skin biopsies: A punch tool removes a small skin sample.
- Tests to see how the pupils react to light
- Smelling tests
- Thinking and memory tests
- Questionnaires
Participants may have a visit about 2 years later to repeat tests.
Read the detailed description
Objective: In dysautonomias, altered function of one or more components of the autonomic nervous system adversely affect health. A subset of dysautonomias consists of chronic autonomic failure (CAF) syndromes. A key sign of CAF is orthostatic hypotension (OH) due to sympathetic neurocirculatory failure (neurognic OH, or nOH). Primary CAF has been classified based on clinical manifestations into three forms - pure autonomic failure (PAF), multiple system atrophy (MSA), and Parkinson's disease with OH (PD+OH). All three forms involve deposition of the protein alpha-synuclein (AS) in neurons (PD, PAF) or glial cells (MSA), and therefore are called autonomic synucleinopathies. Clinical assessment alone often is inadequate for distinguishing among these conditions in individual patients. This observational study continues and expands on Protocol 03-N-0004, "Clinical Laboratory Evaluation of Primary Chronic Autonomic Failure." The overall objective is to refine and conduct multi-modality testing of catecholaminergic and autonomic systems in patients with CAF. The goals are to: (a) improve the differential diagnosis of CAF via laboratory biomarkers; (b) track the natural history of CAF by follow-up testing; (c) apply clinical laboratory biomarkers to gain insights into underlying pathophysiological mechanisms of CAF; and (d) build up rosters of well characterized patients for future experimental therapeutic trials.
Study Population: The study population consists of patients with neurodegenerative CAF identified by on-site screening at the NIH Clinical Center. Comparison groups include control patients with iatrogenic CAF (e.g., status-post cardiac transplantation, pre/post bilateral thoracic sympathectomies) or PD without OH (PD No OH), and Healthy Volunteers (HVs). MSA patients are included, to build up a subject roster for a planned clinical trial.
Design: This is an observational pathophysiology/natural history study with a planned duration of 5 years. Descriptive statistics will be done in diagnostic groups with neurodegenerative CAF.
Outcome Measures: The study is hypothesis generating/exploratory. The primary outcome measure is results of clinical laboratory research tests. Neurobehavioral rating scales include the University of Pennsylvania Smell Identification Test (UPSIT), Montreal Cognitive Assessment (MoCA), and Uniform Parkinson's Disease Rating Scale (UPDRS). Neurochemical data are from assays of catechols and related compounds in plasma or cerebrospinal fluid. Neuroimaging data are from 18F-DOPA, 18F-dopamine, 13N-ammonia, and 11C-methylreboxetine positron emission tomographic (PET) scanning and MRI. Immunofluorescence microscopy is used to quantify immunoreactive tyrosine hydroxylase and AS in skin biopsy samples. Correlation analyses are done among individual values for outcome measures.
- Being tested
- 13N-Ammonia, 18F-DOPA, 11C-Methylreboxetine (11C-MRB), 18F-Dopamine
- Keywords
- Autonomic Failure, Parkinson's Disease, Multiple System Atrophy, Lewy Body, Catecholamines
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy, Pure Autonomic Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13N-AmmoniaDrug
a perfusion imaging agent
18F-DOPADrug
is a positron-emitting analog of the catechol amino acid, levodopa
11C-Methylreboxetine (11C-MRB)Drug
11C-MRB may be injected IV for visualizingsites of neuronal uptake of norepinephrine in the brain or periphery by PET scanning. Setup includes placement of an arm IV catheter. 11C-MRB is a Radioactive Research Drug.
18F-DopamineDrug
is a positron-emitting analog of the catecholamine, dopamine
| Study group | Role | What they receive |
|---|---|---|
| Control patients (iatrogenic CAF) | Patients with iatrogenic chronic autonomic failure (CAF) (e.g., status-post cardiac transplantation, pre/post bilateral thoracic sympathectomies) Receives: Drug: 13N-Ammonia; Drug: 18F-DOPA; Drug: 11C-Methylreboxetine (11C-MRB); Drug: 18F-Dopamine | |
| Control patients (PD No OH) | Patients with Parkinson's disease (PD) without orthostatic hypotension (PD no OH) Receives: Drug: 13N-Ammonia; Drug: 18F-DOPA; Drug: 11C-Methylreboxetine (11C-MRB); Drug: 18F-Dopamine | |
| Healthy Volunteers | Healthy Volunteers, includes people with genetic risk of PD or studied as concurrent controls Receives: Drug: 13N-Ammonia; Drug: 18F-DOPA; Drug: 11C-Methylreboxetine (11C-MRB); Drug: 18F-Dopamine | |
| Patients with neurodegenerative chronic autonomic failure (CAF) | Includes patients with orthostatic hypotension (OH) due to sympathetic neurocirculatory failure (nOH), and people with multiple system atrophy (MSA). Receives: Drug: 13N-Ammonia; Drug: 18F-DOPA; Drug: 11C-Methylreboxetine (11C-MRB); Drug: 18F-Dopamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of clinical laboratory research tests
Neurobehavioral rating scales include the University of Pennsylvania Smell Identification Test (UPSIT), Montreal Cognitive Assessment (MoCA), and Uniform Parkinson s Disease Rating Scale (UPDRS). Neurochemical data are from assays of catechols and related compounds in plasma or cerebrospinal fluid. Neuroimaging data are from 18F-DOPA, 18Fdopamine, 13Nammonia, and 11Cmethylreboxetine positron emission tomographic (PET) scanning and MRI. Immunofluorescence microscopy is used to quantify immunoreactive tyrosine hydroxylase and AS in skin biopsy samples.
Measured: Initial Visit and on an approximately biennial basis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start6 Sep 2018
- Primary completion15 Jul 2026
- Study completion15 Jul 2026
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 National Institute of Neurological Disorders and Stroke (NINDS)The 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Justin Y Kwan, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648905
- Sponsor's protocol ID
- 180140
- Other IDs
- 18-N-0140
- Status last verified
- 17 Jul 2026
- First submitted
- 24 Aug 2018
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Laboratory Evaluation of Chronic Autonomic Failure
- ClinicalTrials.gov ID
- NCT03648905
- Acronym / sponsor ID
- 180140
- Keywords
- Autonomic Failure, Parkinson's Disease, Multiple System Atrophy, Lewy Body, Catecholamines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 28 Aug 2018 (actual)
- 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.
Background:
The autonomic nervous system controls automatic body functions. Researchers want to improve the tests used to diagnose autonomic failure. Orthostatic hypertension is a drop in blood pressure when a person stands up. Researchers want to focus on this sign of autonomic failure.
Objective:
To improve testing for conditions that cause autonomic nervous system failure.
Eligibility:
People ages 18 and older in one of these categories:
- Their blood pressure drops when they get up.
- They have had a heart transplant or bilateral endoscopic thoracic sympathectomies or have had or will have renal sympathetic ablation
Design:
All participants will be screened with:
- Medical history
- Physical exam
- Blood and urine tests
Some participants will be screened with:
- Heart and breathing tests
- IV placement into an arm vein
- Tilt table testing: Participants lie on a table that tilts while an IV is used to draw their blood.
Participants may stay in the hospital for up to 1 week depending on their tests. Tests may include repeats of screening tests and:
- Sweat testing: A drug is placed on the skin to cause sweating. Sensors on the skin measure moisture.
- Lumbar puncture: A needle is inserted between the bones in the back to collect fluid.
- MRI and PET/CT scan: Participants lie on a table that slides into a scanner. For the PET/CT, a small amount of a radioactive chemical will be injected with a small amount of a radioactive chemical.
- Bladder catheter placement to collect urine
- Skin biopsies: A punch tool removes a small skin sample.
- Tests to see how the pupils react to light
- Smelling tests
- Thinking and memory tests
- Questionnaires
Participants may have a visit about 2 years later to repeat tests.
Detailed description
Objective: In dysautonomias, altered function of one or more components of the autonomic nervous system adversely affect health. A subset of dysautonomias consists of chronic autonomic failure (CAF) syndromes. A key sign of CAF is orthostatic hypotension (OH) due to sympathetic neurocirculatory failure (neurognic OH, or nOH). Primary CAF has been classified based on clinical manifestations into three forms - pure autonomic failure (PAF), multiple system atrophy (MSA), and Parkinson's disease with OH (PD+OH). All three forms involve deposition of the protein alpha-synuclein (AS) in neurons (PD, PAF) or glial cells (MSA), and therefore are called autonomic synucleinopathies. Clinical assessment alone often is inadequate for distinguishing among these conditions in individual patients. This observational study continues and expands on Protocol 03-N-0004, "Clinical Laboratory Evaluation of Primary Chronic Autonomic Failure." The overall objective is to refine and conduct multi-modality testing of catecholaminergic and autonomic systems in patients with CAF. The goals are to: (a) improve the differential diagnosis of CAF via laboratory biomarkers; (b) track the natural history of CAF by follow-up testing; (c) apply clinical laboratory biomarkers to gain insights into underlying pathophysiological mechanisms of CAF; and (d) build up rosters of well characterized patients for future experimental therapeutic trials.
Study Population: The study population consists of patients with neurodegenerative CAF identified by on-site screening at the NIH Clinical Center. Comparison groups include control patients with iatrogenic CAF (e.g., status-post cardiac transplantation, pre/post bilateral thoracic sympathectomies) or PD without OH (PD No OH), and Healthy Volunteers (HVs). MSA patients are included, to build up a subject roster for a planned clinical trial.
Design: This is an observational pathophysiology/natural history study with a planned duration of 5 years. Descriptive statistics will be done in diagnostic groups with neurodegenerative CAF.
Outcome Measures: The study is hypothesis generating/exploratory. The primary outcome measure is results of clinical laboratory research tests. Neurobehavioral rating scales include the University of Pennsylvania Smell Identification Test (UPSIT), Montreal Cognitive Assessment (MoCA), and Uniform Parkinson's Disease Rating Scale (UPDRS). Neurochemical data are from assays of catechols and related compounds in plasma or cerebrospinal fluid. Neuroimaging data are from 18F-DOPA, 18F-dopamine, 13N-ammonia, and 11C-methylreboxetine positron emission tomographic (PET) scanning and MRI. Immunofluorescence microscopy is used to quantify immunoreactive tyrosine hydroxylase and AS in skin biopsy samples. Correlation analyses are done among individual values for outcome measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control patients (iatrogenic CAF) | – | Drug: 13N-Ammonia, Drug: 18F-DOPA, Drug: 11C-Methylreboxetine (11C-MRB), Drug: 18F-DopaminePatients with iatrogenic chronic autonomic failure (CAF) (e.g., status-post cardiac transplantation, pre/post bilateral thoracic sympathectomies) |
| Control patients (PD No OH) | – | Drug: 13N-Ammonia, Drug: 18F-DOPA, Drug: 11C-Methylreboxetine (11C-MRB), Drug: 18F-DopaminePatients with Parkinson's disease (PD) without orthostatic hypotension (PD no OH) |
| Healthy Volunteers | – | Drug: 13N-Ammonia, Drug: 18F-DOPA, Drug: 11C-Methylreboxetine (11C-MRB), Drug: 18F-DopamineHealthy Volunteers, includes people with genetic risk of PD or studied as concurrent controls |
| Patients with neurodegenerative chronic autonomic failure (CAF) | – | Drug: 13N-Ammonia, Drug: 18F-DOPA, Drug: 11C-Methylreboxetine (11C-MRB), Drug: 18F-DopamineIncludes patients with orthostatic hypotension (OH) due to sympathetic neurocirculatory failure (nOH), and people with multiple system atrophy (MSA). |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with neurodegenerative CAF and patients with MSA. Comparison groups include control patients with iatrogenic CAF, patients with PD without OH (PD No OH), and Healthy Volunteers (HVs).
Key inclusion criteria (15 listed)
- Inclusion Critieria: Patients referred for orthostatic hypotension. This is the main subject cohort.
- Previously studied and diagnosed with one of the forms of nOH or else newly accrued with a referral diagnosis of orthostatic hypotension, and
- 18 years or older, and
- Able to provide own consent to participate or have an existing Legally Authorized Representative (LAR).
- If a patient has already been diagnosed as having neurodegenerative CAF under NIH Clinical Protocol 03-N-0004, this satisfies the inclusion criteria for that patient. Previous enrollment in NIH Clinical Protocol 03-N-0004 is not required for enrollment in this study. We do plan to recruit participation into this study from NIH Clinical Protocol 03-N-0004, which has been closed.
Key exclusion criteria (34 listed)
- Patient Group Referred for Orthostatic Hypotension
- A medical condition that in the judgment of the Principal Investigator would place the subject at substantially increased acute medical risk, or
- A disqualifying condition such as: hepatic or renal failure, symptomatic congestive heart failure, severe anemia, psychosis, refractory ventricular arrhythmias, currently symptomatic coronary heart disease, cerebrovascular disease with current symptoms (e.g., recent transient ischemic attacks), diabetes, or
- Secondary form of CAF, such as diabetic autonomic neuropathy, or
- Being treated currently (within 2 weeks of anticipated protocol participation) with a medication known to interfere with the cell membrane norepinephrine transporter, which would obviate obtaining scientifically valid results (e.g., tricyclic antidepressant).
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 |
|---|---|---|
| 13N-Ammoniaa perfusion imaging agent | Drug | Control patients (PD No OH), Control patients (iatrogenic CAF), Healthy Volunteers, Patients with neurodegenerative chronic autonomic failure (CAF) |
| 18F-DOPAis a positron-emitting analog of the catechol amino acid, levodopa | Drug | Control patients (PD No OH), Control patients (iatrogenic CAF), Healthy Volunteers, Patients with neurodegenerative chronic autonomic failure (CAF) |
| 11C-Methylreboxetine (11C-MRB)11C-MRB may be injected IV for visualizingsites of neuronal uptake of norepinephrine in the brain or periphery by PET scanning. Setup includes placement of an arm IV catheter. 11C-MRB is a Radioactive Research Drug. | Drug | Control patients (PD No OH), Control patients (iatrogenic CAF), Healthy Volunteers, Patients with neurodegenerative chronic autonomic failure (CAF) |
| 18F-Dopamineis a positron-emitting analog of the catecholamine, dopamine | Drug | Control patients (PD No OH), Control patients (iatrogenic CAF), Healthy Volunteers, Patients with neurodegenerative chronic autonomic failure (CAF) |
Primary outcome
Results of clinical laboratory research tests
Time frame: Initial Visit and on an approximately biennial basis
Neurobehavioral rating scales include the University of Pennsylvania Smell Identification Test (UPSIT), Montreal Cognitive Assessment (MoCA), and Uniform Parkinson s Disease Rating Scale (UPDRS). Neurochemical data are from assays of catechols and related compounds in plasma or cerebrospinal fluid. Neuroimaging data are from 18F-DOPA, 18Fdopamine, 13Nammonia, and 11Cmethylreboxetine positron emission tomographic (PET) scanning and MRI. Immunofluorescence microscopy is used to quantify immunoreactive tyrosine hydroxylase and AS in skin biopsy samples.
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 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Justin Y Kwan, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Multiple System Atrophy, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 15 inclusion and 34 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 26 Oct 2026. 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?
Results of clinical laboratory research tests (time frame: Initial Visit and on an approximately biennial basis). 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 26 Oct 2026.