Parkinson DiseaseNCT00775853
Biomarkers of Risk of Parkinson Disease
An observational study of Parkinson Disease and Autonomic Nervous System Diseases, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study (https://pdrisk.ninds.nih.gov) will determine if people who have risk factors for Parkinson disease (PD) have biomarkers (objective ways to measure a disease process) that show that the disease process is actually going on, and if people who have abnormal biomarkers go on to develop PD during several years… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parkinson Disease, Autonomic Nervous System Diseases, Pure Autonomic Failure
- What is being tested?
- 6-[18F]Fluorodopamine, 6-[18F]Fluorodopa and 13N-Ammonia
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2009to 11 Jan 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects are individuals who may be at risk for developing PD, because of (a) genetic risk i.e., a family history of PD or genotypic abnormalities known to be associated statistically with PD; (b) olfactory dysfunction i.e., decreased ability to distinguish among odors; (c) symptomatic rapid eye movement (REM) sleep behavior disorder (RBD); or (d) orthostatic hypotension.
Who may be able to join
- Individuals who report at least 3 of the following 4 risk factors at the protocol-specific website may be invited to the Screening Examination. All subjects must have ability to provide their own consent for participation in the study. Otherwise eligible candidate participants who are taking medications that would interfere with the scientific results may be included, if (1) the medications are held temporarily or safely substituted for, and (2) the medications are held while the participants are inpatients. The prescribing physician will be contacted, with the participant's permission, if withholding or substituting medication is considered.
- Genetic Risk: A positive family history (one immediate or more than one non-immediate family member with PD) or positive genetic testing (e.g., LRRK2, alpha-synuclein, glucocerebrosidase) satisfies this risk factor criterion.
- Olfactory Dysfunction: Olfactory dysfunction reported at the protocol-specific website satisfies this criterion. This may be confirmed by the UPSIT sent by mail prior to the Screening Examination.
- REM Behavior Disorder (RBD): To satisfy this risk factor criterion, the individual must have movements of the body or limbs associated with dreaming and at least one of the following: potentially harmful sleep behavior, dreams that appear to be acted out, and sleep behavior that disrupts sleep continuity.
- Orthostatic Hypotension (OH): To satisfy this risk factor criterion, the individual reports symptoms of orthostatic hypotension or having orthostatic hypotension at the protocol-specific website. This may be confirmed by orthostatic vital signs prior to the Screening Examination.
Who cannot join
- Age: People younger than 18 years old or older than 70 years old are excluded.
- Risk: A candidate subject is excluded if, in the judgment of the Principal Investigator, Protocol participation would place the subject at substantially increased acute medical risk. This includes the risks associated with air travel to the NIH. A candidate subject may be excluded from the study if, in the opinion of the Principal Investigator or Clinical Director, the medical risk outweighs the potential scientific benefit. An example of such risk is inability to travel safely to the NIH Clinical Center, in Bethesda, Maryland, due to a neurological disorder associated with frequent falls.
- Disqualifying Conditions: A candidate subject is excluded if there is a disqualifying condition. Examples of disqualifying conditions are insulin-dependent diabetes, hepatic or renal failure, symptomatic congestive heart failure, severe anemia, psychosis, ventricular arrhythmias, and symptomatic coronary heart disease.
- Unable to Provide Consent: Persons who are unable to provide their own consent (e.g., due to dementia) are excluded.
- MRI: Persons who are unable to undergo MRI safely, due to implanted metal, are excluded from the MRI procedure.
- Safe Travel: A candidate participant is excluded if the person is unable to travel safely to the NIH Clinical Center, in Bethesda, Maryland, such as due to a neurological disorder associated with frequent falls.
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- Medications: A candidate subject is excluded if clinical considerations require continued treatment with a drug likely to interfere with the scientific results. Chronic, ongoing use of drugs such as tricyclic antidepressants that affect the clinical laboratory results exclude candidate subjects. People with known or suspected allergy or hypersensitivity to any test drug are excluded. Candidate subjects are not to discontinue any medications before discussion with the Principal Investigator, Research Nurse, Nurse Practitioner, or Clinical Fellow. Temporary discontinuation of serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine (Effexor), duloxetine (Cymbalta), or des-venlafaxine (Pristiq) can result in rapid rebound of depression or anxiety, and so treatment with SNRIs is exclusionary.
- Herbal Medicines and Dietary Supplements: If a subject wishes to continue herbal medicines or dietary supplements while on study, but a search of the available medical identifies drug effects that are known or expected to interfere with the experimental results, then the subject may be excluded, at the discretion of Principal Investigator
- Practical Limitations: People in whom we feel it would be difficult to insert a catheter into a vein may be excluded. People who are not expected clinically to tolerate lying still supine during the testing will be excluded.
- Pregnancy: Pregnant or lactating women are excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
This study (https://pdrisk.ninds.nih.gov) will determine if people who have risk factors for Parkinson disease (PD) have biomarkers (objective ways to measure a disease process) that show that the disease process is actually going on, and if people who have abnormal biomarkers go on to develop PD during several years of follow-up. Biomarkers of Parkinson disease (PD) might identify people who are healthy now but may develop the disease later in life.
Healthy volunteers and people who have certain risk factors for developing PD who are between 18 and 70 years of age may be eligible for this study. People with the following risk factors are included:
Read more
- Family history of PD
- Loss of sense of smell
- Fall in blood pressure when standing up
- REM behavior disorder (a type of sleep disturbance)
Participants undergo the following tests and procedures:
- Screening examination
- Medical and neurological history and physical examination
- Tests or rating scales for movement, sense of smell, mood, attention, fatigue, pain, and thinking.
- Measurement of blood pressure and pulse rate while lying down and then standing up
- Blood draw for genetic testing
- Inpatient testing at the NIH Clinical Center for 2-3 days, including:
- Measurements while blowing against a resistance
- Measurements of blood pressure and pulse rate
- Blood draws for levels of various chemicals
- PET and MRI scanning
- Lumbar puncture (spinal tap)
- Electrocardiogram
- Skin electrical conduction test (test of sweat production)
- Skin and core temperature measurements
- Transcranial ultrasound (sound-wave test of the head)
- Follow-up testing (up to five visits in 18-month intervals) to repeat some of the tests listed above, excluding the genetic testing and spinal tap
Read the detailed description
Objective: By the time an individual develops motor symptoms or signs of Parkinson disease (PD) the degeneration of nigrostriatal dopaminergic neurons that produces the movement disorder is already advanced. It is important to identify individuals in whom the pathogenetic process is in a preclinical or prodromal phase. Such individuals would be the best candidates for disease modification clinical trials. PD is characterized by the loss of neurons that use catecholamines as the neurotransmitters, both in the brain and heart. This study is designed to test whether, among people with multiple PD risk factors (at least 3 of the following: family history of PD or genetic risk, olfactory dysfunction, dream enactment behavior, orthostatic hypotension), those with biomarkers of central or myocardial catecholaminergic neurodegeneration are diagnosed with motor symptoms and signs of PD within 7.5 years of follow-up, whereas those with the same risk factors but without biomarkers of catecholaminergic neurodegeneration in either the brain or heart are not diagnosed with motor symptoms and signs of PD during follow-up. Results so far from this study have shown that low cerebrospinal fluid (CSF) levels of 3,4-dihydroxyphenylacetic acid (DOPAC, the main neuronal metabolite of the catecholamine dopamine) and of 3,4-dihydroxyphenylanine (DOPA, the precursor of the catecholamines), low myocardial concentrations of 18F-dopamine-derived radioactivity (an index of deficiency of the catecholamine norepinephrine), and low putamen/occipital cortex ratios of 18F-DOPA-derived radioactivity (an index of putamen dopamine deficiency) distinguish at-risk participants who are diagnosed with motor symptoms and signs of PD within 3 years of follow-up. The study is being continued to follow participants with initial biomarkers data who have not yet been diagnosed with PD. In the follow-up phase we plan on answering the following questions: (1) What proportion of at-risk subjects with negative biomarkers at the time of initial testing develop symptoms of PD during 7.5 years of follow-up? (2) What proportion of at-risk subjects with 1 or 2 positive biomarkers at the time of initial testing develop the motor symptoms and signs of PD during 7.5 years of follow-up? (3) In at-risk subjects who convert from negative to positive biomarkers during follow-up, what proportion develop the motor symptoms and signs of PD during the remaining period until 7.5 years of follow-up?
Study Population: The subjects are individuals who may be at risk for developing PD, because of (a) genetic risk i.e., a family history of PD or genotypic abnormalities known to be associated statistically with PD; (b) olfactory dysfunction i.e., decreased ability to distinguish among odors; (c) symptomatic rapid eye movement (REM) sleep behavior disorder (RBD); or (d) orthostatic hypotension. A total of 200 at-risk subjects undergo catecholaminergic biomarker testing by 18F-DOPA brain and 18F-dopamine cardiac scanning. At-risk subjects with positive biomarkers are compared to at-risk subjects without positive biomarkers, in terms of development of PD during follow-up. Up to 20 control subjects are included, to add to a database of normal values for catecholaminergic biomarkers. As of May 2015, accrual was completed, and participants who already have been characterized in terms of risk factors and biomarkers are in the follow-up phase of the study.
Design: The study includes four phases recruitment, screening, laboratory biomarkers testing, and follow-up. Recruitment is by advertisement and a web site questionnaire of self-reported risk. A screening examination is done at the NIH Clinical Center, to confirm risk status. Based on the screening examination results, subjects undergo inpatient clinical laboratory testing, to identify central and peripheral catecholaminergic denervation. Since May 2015, the study has been in the follow-up phase, during which subjects are being re-tested as inpatients approximately every 18 months for a total of up to 5 re-evaluations (90 months, or 7.5 years), to detect the onset of the characteristic movement disorder in PD and follow the status of putamen and myocardial catecholaminergic innervation.
Outcome Measures:
The primary outcome measure is a clinical diagnosis of PD by a Board-certified neurologist who is blinded to risk factor status and the results of catecholaminergic biomarkers testing; or else completing 7.5 years of follow-up without a diagnosis of PD. If PD diagnosed, time to diagnosis. Secondary outcome measures are the results of UPDRS; F-DOPA brain scanning, F-dopamine cardiac scanning; CSF and plasma neurochemicals; neuropsychological rating scales; autonomic function testing, retrospective CSF proteomics; retrospective DNA analyses.
- Being tested
- 6-[18F]Fluorodopamine, 6-[18F]Fluorodopa, 13N-Ammonia
- Keywords
- Biomarkers, Catecholamines, 18F-Fluoro-L-dopa, Fluorodopamine, Parkinson's Disease, Natural History, Parkinson Disease, PD
- Medical subject headings
- Parkinson Disease, Autonomic Nervous System Diseases, Pure Autonomic Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-[18F]FluorodopamineDrug
6-[18F]FluorodopaDrug
13N-AmmoniaDrug
| Study group | Role | What they receive |
|---|---|---|
| Individuals at risk for developing PD | Individuals who may be at risk for developing PD because of genetic risk, olfactory dysfunction, symptomatic rapid eye movement sleep behavior disorder, or orthostatic hypotension Receives: Drug: 6-[18F]Fluorodopamine; Drug: 6-[18F]Fluorodopa; Drug: 13N-Ammonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinson Disease Diagnosed
The primary objective of this study is to determine whether among people at increased statistical risk for developing PD those with clinical laboratory biomarkers of central or cardiac catecholamine deficiency are diagnosed with PD during follow-up, whereas those without evidence of central or peripheral catecholamine deficiency are not diagnosed with PD during follow-up.
Measured: annually within 7.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study start27 May 2009
- Primary completion11 Jan 2023
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson 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
- Other
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David S Goldstein, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775853
- Sponsor's protocol ID
- 090010
- Other IDs
- 09-N-0010
- Status last verified
- Sep 2025
- First submitted
- 17 Oct 2008
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goldstein DS, Holmes C, Sullivan P, Lopez G, Gelsomino J, Moore S, Isonaka R, Wu T, Sharabi Y. Cardiac noradrenergic deficiency revealed by 18F-dopamine positron emission tomography identifies preclinical central Lewy body diseases. J Clin Invest. 2024 Jan 2;134(1):e172460. doi: 10.1172/JCI172460.
PubMed 37883190
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Risk of Parkinson Disease
- ClinicalTrials.gov ID
- NCT00775853
- Acronym / sponsor ID
- 090010
- Keywords
- Biomarkers, Catecholamines, 18F-Fluoro-L-dopa, Fluorodopamine, Parkinson's Disease, Natural History, Parkinson Disease, PD
- 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
- 27 May 2009 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 20 Oct 2008 (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 (https://pdrisk.ninds.nih.gov) will determine if people who have risk factors for Parkinson disease (PD) have biomarkers (objective ways to measure a disease process) that show that the disease process is actually going on, and if people who have abnormal biomarkers go on to develop PD during several years of follow-up. Biomarkers of Parkinson disease (PD) might identify people who are healthy now but may develop the disease later in life.
Healthy volunteers and people who have certain risk factors for developing PD who are between 18 and 70 years of age may be eligible for this study. People with the following risk factors are included:
- Family history of PD
- Loss of sense of smell
- Fall in blood pressure when standing up
- REM behavior disorder (a type of sleep disturbance)
Participants undergo the following tests and procedures:
- Screening examination
- Medical and neurological history and physical examination
- Tests or rating scales for movement, sense of smell, mood, attention, fatigue, pain, and thinking.
- Measurement of blood pressure and pulse rate while lying down and then standing up
- Blood draw for genetic testing
- Inpatient testing at the NIH Clinical Center for 2-3 days, including:
- Measurements while blowing against a resistance
- Measurements of blood pressure and pulse rate
- Blood draws for levels of various chemicals
- PET and MRI scanning
- Lumbar puncture (spinal tap)
- Electrocardiogram
- Skin electrical conduction test (test of sweat production)
- Skin and core temperature measurements
- Transcranial ultrasound (sound-wave test of the head)
- Follow-up testing (up to five visits in 18-month intervals) to repeat some of the tests listed above, excluding the genetic testing and spinal tap
Detailed description
Objective: By the time an individual develops motor symptoms or signs of Parkinson disease (PD) the degeneration of nigrostriatal dopaminergic neurons that produces the movement disorder is already advanced. It is important to identify individuals in whom the pathogenetic process is in a preclinical or prodromal phase. Such individuals would be the best candidates for disease modification clinical trials. PD is characterized by the loss of neurons that use catecholamines as the neurotransmitters, both in the brain and heart. This study is designed to test whether, among people with multiple PD risk factors (at least 3 of the following: family history of PD or genetic risk, olfactory dysfunction, dream enactment behavior, orthostatic hypotension), those with biomarkers of central or myocardial catecholaminergic neurodegeneration are diagnosed with motor symptoms and signs of PD within 7.5 years of follow-up, whereas those with the same risk factors but without biomarkers of catecholaminergic neurodegeneration in either the brain or heart are not diagnosed with motor symptoms and signs of PD during follow-up. Results so far from this study have shown that low cerebrospinal fluid (CSF) levels of 3,4-dihydroxyphenylacetic acid (DOPAC, the main neuronal metabolite of the catecholamine dopamine) and of 3,4-dihydroxyphenylanine (DOPA, the precursor of the catecholamines), low myocardial concentrations of 18F-dopamine-derived radioactivity (an index of deficiency of the catecholamine norepinephrine), and low putamen/occipital cortex ratios of 18F-DOPA-derived radioactivity (an index of putamen dopamine deficiency) distinguish at-risk participants who are diagnosed with motor symptoms and signs of PD within 3 years of follow-up. The study is being continued to follow participants with initial biomarkers data who have not yet been diagnosed with PD. In the follow-up phase we plan on answering the following questions: (1) What proportion of at-risk subjects with negative biomarkers at the time of initial testing develop symptoms of PD during 7.5 years of follow-up? (2) What proportion of at-risk subjects with 1 or 2 positive biomarkers at the time of initial testing develop the motor symptoms and signs of PD during 7.5 years of follow-up? (3) In at-risk subjects who convert from negative to positive biomarkers during follow-up, what proportion develop the motor symptoms and signs of PD during the remaining period until 7.5 years of follow-up?
Study Population: The subjects are individuals who may be at risk for developing PD, because of (a) genetic risk i.e., a family history of PD or genotypic abnormalities known to be associated statistically with PD; (b) olfactory dysfunction i.e., decreased ability to distinguish among odors; (c) symptomatic rapid eye movement (REM) sleep behavior disorder (RBD); or (d) orthostatic hypotension. A total of 200 at-risk subjects undergo catecholaminergic biomarker testing by 18F-DOPA brain and 18F-dopamine cardiac scanning. At-risk subjects with positive biomarkers are compared to at-risk subjects without positive biomarkers, in terms of development of PD during follow-up. Up to 20 control subjects are included, to add to a database of normal values for catecholaminergic biomarkers. As of May 2015, accrual was completed, and participants who already have been characterized in terms of risk factors and biomarkers are in the follow-up phase of the study.
Design: The study includes four phases recruitment, screening, laboratory biomarkers testing, and follow-up. Recruitment is by advertisement and a web site questionnaire of self-reported risk. A screening examination is done at the NIH Clinical Center, to confirm risk status. Based on the screening examination results, subjects undergo inpatient clinical laboratory testing, to identify central and peripheral catecholaminergic denervation. Since May 2015, the study has been in the follow-up phase, during which subjects are being re-tested as inpatients approximately every 18 months for a total of up to 5 re-evaluations (90 months, or 7.5 years), to detect the onset of the characteristic movement disorder in PD and follow the status of putamen and myocardial catecholaminergic innervation.
Outcome Measures:
The primary outcome measure is a clinical diagnosis of PD by a Board-certified neurologist who is blinded to risk factor status and the results of catecholaminergic biomarkers testing; or else completing 7.5 years of follow-up without a diagnosis of PD. If PD diagnosed, time to diagnosis. Secondary outcome measures are the results of UPDRS; F-DOPA brain scanning, F-dopamine cardiac scanning; CSF and plasma neurochemicals; neuropsychological rating scales; autonomic function testing, retrospective CSF proteomics; retrospective DNA analyses.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals at risk for developing PD | – | Drug: 6-[18F]Fluorodopamine, Drug: 6-[18F]Fluorodopa, Drug: 13N-AmmoniaIndividuals who may be at risk for developing PD because of genetic risk, olfactory dysfunction, symptomatic rapid eye movement sleep behavior disorder, or orthostatic hypotension |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects are individuals who may be at risk for developing PD, because of (a) genetic risk i.e., a family history of PD or genotypic abnormalities known to be associated statistically with PD; (b) olfactory dysfunction i.e., decreased ability to distinguish among odors; (c) symptomatic rapid eye movement (REM) sleep behavior disorder (RBD); or (d) orthostatic hypotension.
Key inclusion criteria (5 listed)
- Individuals who report at least 3 of the following 4 risk factors at the protocol-specific website may be invited to the Screening Examination. All subjects must have ability to provide their own consent for participation in the study. Otherwise eligible candidate participants who are taking medications that would interfere with the scientific results may be included, if (1) the medications are held temporarily or safely substituted for, and (2) the medications are held while the participants are inpatients. The prescribing physician will be contacted, with the participant's permission, if withholding or substituting medication is considered.
- Genetic Risk: A positive family history (one immediate or more than one non-immediate family member with PD) or positive genetic testing (e.g., LRRK2, alpha-synuclein, glucocerebrosidase) satisfies this risk factor criterion.
- Olfactory Dysfunction: Olfactory dysfunction reported at the protocol-specific website satisfies this criterion. This may be confirmed by the UPSIT sent by mail prior to the Screening Examination.
- REM Behavior Disorder (RBD): To satisfy this risk factor criterion, the individual must have movements of the body or limbs associated with dreaming and at least one of the following: potentially harmful sleep behavior, dreams that appear to be acted out, and sleep behavior that disrupts sleep continuity.
- Orthostatic Hypotension (OH): To satisfy this risk factor criterion, the individual reports symptoms of orthostatic hypotension or having orthostatic hypotension at the protocol-specific website. This may be confirmed by orthostatic vital signs prior to the Screening Examination.
Key exclusion criteria (10 listed)
- Age: People younger than 18 years old or older than 70 years old are excluded.
- Risk: A candidate subject is excluded if, in the judgment of the Principal Investigator, Protocol participation would place the subject at substantially increased acute medical risk. This includes the risks associated with air travel to the NIH. A candidate subject may be excluded from the study if, in the opinion of the Principal Investigator or Clinical Director, the medical risk outweighs the potential scientific benefit. An example of such risk is inability to travel safely to the NIH Clinical Center, in Bethesda, Maryland, due to a neurological disorder associated with frequent falls.
- Disqualifying Conditions: A candidate subject is excluded if there is a disqualifying condition. Examples of disqualifying conditions are insulin-dependent diabetes, hepatic or renal failure, symptomatic congestive heart failure, severe anemia, psychosis, ventricular arrhythmias, and symptomatic coronary heart disease.
- Medications: A candidate subject is excluded if clinical considerations require continued treatment with a drug likely to interfere with the scientific results. Chronic, ongoing use of drugs such as tricyclic antidepressants that affect the clinical laboratory results exclude candidate subjects. People with known or suspected allergy or hypersensitivity to any test drug are excluded. Candidate subjects are not to discontinue any medications before discussion with the Principal Investigator, Research Nurse, Nurse Practitioner, or Clinical Fellow. Temporary discontinuation of serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine (Effexor), duloxetine (Cymbalta), or des-venlafaxine (Pristiq) can result in rapid rebound of depression or anxiety, and so treatment with SNRIs is exclusionary.
- Herbal Medicines and Dietary Supplements: If a subject wishes to continue herbal medicines or dietary supplements while on study, but a search of the available medical identifies drug effects that are known or expected to interfere with the experimental results, then the subject may be excluded, at the discretion of Principal Investigator
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 |
|---|---|---|
| 6-[18F]Fluorodopamine | Drug | Individuals at risk for developing PD |
| 6-[18F]Fluorodopa | Drug | Individuals at risk for developing PD |
| 13N-Ammonia | Drug | Individuals at risk for developing PD |
Primary outcome
Parkinson Disease Diagnosed
Time frame: annually within 7.5 years
The primary objective of this study is to determine whether among people at increased statistical risk for developing PD those with clinical laboratory biomarkers of central or cardiac catecholamine deficiency are diagnosed with PD during follow-up, whereas those without evidence of central or peripheral catecholamine deficiency are not diagnosed with PD during follow-up.
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 19 Sep 2025.
- Derived from this study: PubMed 37883190Goldstein DS, Holmes C, Sullivan P, Lopez G, Gelsomino J, Moore S, Isonaka R, Wu T, Sharabi Y. Cardiac noradrenergic deficiency revealed by 18F-dopamine positron emission tomography identifies preclinical central Lewy body diseases. J Clin Invest. 2024 Jan 2;134(1):e172460. doi: 10.1172/JCI172460.
- 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.
David S Goldstein, 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 Disease and Autonomic Nervous System Diseases, 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 5 inclusion and 10 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 19 Sep 2025. 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?
Parkinson Disease Diagnosed (time frame: annually within 7.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00775853, which also lists 1 linked publication.
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 19 Sep 2025.