Parkinson DiseaseNCT01565473
PET Study of Non-Motor Symptoms of Parkinson Disease
An observational study of Parkinson Disease, run by University of Michigan at 1 site in United States.
Trial summary
This research plan is focused on neurochemical positron emission tomography (PET) studies of Parkinson disease (PD). PD is the most common neurodegenerative movement disorder, and considerable progress has been made in understanding and treating the "typical" movement abnormalities of resting tremor, bradykinesia and… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jul 2014
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Movement Disorders Clinic, Hospital, Primary Care, Community
Who may be able to join
- age 50 and above (40 for Normal Control population)
- diagnosed with PD
- Hoehn \& Yahr 1-4,
Who cannot join
- other disorders which may resemble PD
- unstable medical conditions
- significant neurological or psychiatric disorders
- taking certain medications such as acetylcholinesterase inhibitors, neuroleptics, psychostimulants, tricyclic antidepressants,
- contraindication to MRI (pacemakers, metal in eye, etc)
- recent exposure to significant amount of ionizing radiation
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: PET Study of Biochemistry and Metabolism of the CNS: Parkinson Disease
This research plan is focused on neurochemical positron emission tomography (PET) studies of Parkinson disease (PD). PD is the most common neurodegenerative movement disorder, and considerable progress has been made in understanding and treating the "typical" movement abnormalities of resting tremor, bradykinesia and rigidity. These cardinal PD features are all initially responsive to dopamine replacement therapy, and have been investigated intensively with respect to their relationships to degeneration of the nigrostriatal dopamine projection. More recently, increased attention has focused on the "non-motor" clinical aspects of PD, including cognitive, mood, chronobiological and peripheral autonomic defects. These clinical features are less reliably affected by dopaminergic therapy, and are likely to be associated with other, non-dopaminergic neural degenerations. Indeed, detailed postmortem assessments of PD brain reveal substantial neuronal losses in a variety of chemically-defined neurons, including brainstem serotonin and norepinephrine neurons and basal forebrain cholinergic neurons. Projects in the proposal will focus on dementia, depression, sleep-apnea and dysautonomia in PD patients, employing PET measures of presynaptic dopaminergic, serotoninergic and cholinergic CNS neurons and of peripheral sympathetic neurons. Results of the investigations may identify associations of non-motor PD signs and symptoms with the non-dopaminergic neuronal losses. These findings will establish additional therapeutic targets for symptomatic, but also for potential neuroprotective PD therapies. In addition, a majority of patients will be characterized with all 3 CNS PET measures. The availability of multiple markers of distinct neuronal populations involved in PD neurodegeneration will permit exploratory analyses to assess whether the degenerations are correlated (possibly manifestations of a common pathophysiology) or apparently independent (possibly a manifestation of multiple PD subtypes or pathophysiologies). Ultimately, better understanding of these non-motor features will be essential to developing future treatments that address the entire PD patient.
Read the detailed description
Participating subjects may be eligible for one or more of the sub-projects that may have a focus on cognition, mood, sleep or autonomic symptoms.
- Conditions
- Parkinson Disease
- Keywords
- non-motor symptoms
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson disease patients | Not described | |
| Healthy normal controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses the non-motor aspects of PD
The non-motor aspects that were studied included, sleep disorders, depression, memory, and autonomic system symptom.
Measured: at initial visit and at 2 years for memory (PIB) and autonomic system symptoms (DTBZ and HED)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startSep 2008
- Primary completionJul 2014
- Study completionJul 2014
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 University of MichiganThe 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
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolaas Bohnen, MD, PhD, University of Michigan
- Investigators
- Nicolaas Bohnen, M.D., Ph.D., Study director, University of MichiganKirk Frey, M.D., Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565473
- Sponsor's protocol ID
- P01NS015655
- Status last verified
- Dec 2014
- First submitted
- 26 Mar 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhou Z, Muller MLTM, Kanel P, Chua J, Kotagal V, Kaufer DI, Albin RL, Frey KA, Bohnen NI. Apathy rating scores and beta-amyloidopathy in patients with Parkinson disease at risk for cognitive decline. Neurology. 2020 Jan 28;94(4):e376-e383. doi: 10.1212/WNL.0000000000008683. Epub 2019 Nov 15.
PubMed 31732566
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Study of Biochemistry and Metabolism of the CNS: Parkinson Disease
- ClinicalTrials.gov ID
- NCT01565473
- Acronym / sponsor ID
- P01NS015655
- Conditions
- Parkinson Disease
- Keywords
- non-motor symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 28 Mar 2012 (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 research plan is focused on neurochemical positron emission tomography (PET) studies of Parkinson disease (PD). PD is the most common neurodegenerative movement disorder, and considerable progress has been made in understanding and treating the "typical" movement abnormalities of resting tremor, bradykinesia and rigidity. These cardinal PD features are all initially responsive to dopamine replacement therapy, and have been investigated intensively with respect to their relationships to degeneration of the nigrostriatal dopamine projection. More recently, increased attention has focused on the "non-motor" clinical aspects of PD, including cognitive, mood, chronobiological and peripheral autonomic defects. These clinical features are less reliably affected by dopaminergic therapy, and are likely to be associated with other, non-dopaminergic neural degenerations. Indeed, detailed postmortem assessments of PD brain reveal substantial neuronal losses in a variety of chemically-defined neurons, including brainstem serotonin and norepinephrine neurons and basal forebrain cholinergic neurons. Projects in the proposal will focus on dementia, depression, sleep-apnea and dysautonomia in PD patients, employing PET measures of presynaptic dopaminergic, serotoninergic and cholinergic CNS neurons and of peripheral sympathetic neurons. Results of the investigations may identify associations of non-motor PD signs and symptoms with the non-dopaminergic neuronal losses. These findings will establish additional therapeutic targets for symptomatic, but also for potential neuroprotective PD therapies. In addition, a majority of patients will be characterized with all 3 CNS PET measures. The availability of multiple markers of distinct neuronal populations involved in PD neurodegeneration will permit exploratory analyses to assess whether the degenerations are correlated (possibly manifestations of a common pathophysiology) or apparently independent (possibly a manifestation of multiple PD subtypes or pathophysiologies). Ultimately, better understanding of these non-motor features will be essential to developing future treatments that address the entire PD patient.
Detailed description
Participating subjects may be eligible for one or more of the sub-projects that may have a focus on cognition, mood, sleep or autonomic symptoms.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson disease patients | – | – |
| Healthy normal controls | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Movement Disorders Clinic, Hospital, Primary Care, Community
Key inclusion criteria (3 listed)
- age 50 and above (40 for Normal Control population)
- diagnosed with PD
- Hoehn \& Yahr 1-4,
Key exclusion criteria (7 listed)
- other disorders which may resemble PD
- unstable medical conditions
- significant neurological or psychiatric disorders
- taking certain medications such as acetylcholinesterase inhibitors, neuroleptics, psychostimulants, tricyclic antidepressants,
- contraindication to MRI (pacemakers, metal in eye, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To asses the non-motor aspects of PD
Time frame: at initial visit and at 2 years for memory (PIB) and autonomic system symptoms (DTBZ and HED)
The non-motor aspects that were studied included, sleep disorders, depression, memory, and autonomic system symptom.
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 2 Dec 2014.
- Derived from this study: PubMed 31732566Zhou Z, Muller MLTM, Kanel P, Chua J, Kotagal V, Kaufer DI, Albin RL, Frey KA, Bohnen NI. Apathy rating scores and beta-amyloidopathy in patients with Parkinson disease at risk for cognitive decline. Neurology. 2020 Jan 28;94(4):e376-e383. doi: 10.1212/WNL.0000000000008683. Epub 2019 Nov 15.
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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.
Nicolaas Bohnen, M.D., Ph.D. study director
University of Michigan
Kirk Frey, M.D., Ph.D. principal investigator
University of Michigan
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, run by University of Michigan 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 3 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 2 Dec 2014. 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?
To asses the non-motor aspects of PD (time frame: at initial visit and at 2 years for memory (PIB) and autonomic system symptoms (DTBZ and HED)). 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 NCT01565473, 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 2 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.