Parkinson's DiseaseUDALLNCT02458430
Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease
An observational study of Parkinson's Disease, run by University of Michigan at 1 site in United States.
Trial summary
Balance and gait problems cause severe impairments for people with Parkinson's disease In some Parkinson's disease patients the investigators see a loss of acetylcholine in the brain. Read more about this study
- Who is it for?
- Ages 50 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2015to Dec 2020
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ago 50 and over
Who may be able to join
- Age 50 and above (M/F).
- PD diagnosis (with or without mild cognitive impairment; MCI) will follow the UK Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria for PD (47), consistent with the typical nigrostriatal denervation pattern on VMAT2. Absence of significant dementia confirmed by neuropsychological testing. Modified Hoehn and Yahr stages 1-4 (48, 49).
- PSP diagnosis will follow the NINDS-PSP clinical diagnostic criteria (50, 51).
- All PD subjects will be required to have nigrostriatal dopaminergic denervation as demonstrated by [11C]DTBZ PET imaging (52, 53). Subjects with Parkinsonism and absence of this PD-typical pattern will be re-categorized .
Who cannot join
- 1. Presence of significant dementia. 2. Disorders which may resemble PD or PSP, such as dementia with Lewy bodies, vascular dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism. The use of the UKPDSBRC and NINDS-PSP clinical diagnostic criteria will mitigate the inclusion of patients with atypical parkinsonism.
- 3. Subjects on neuroleptic (except for low dose quetiapine 25-50 mg/d), anticholinergic (trihexyphenidyl, benztropine), cholinesterase inhibitors. Subjects with prior exposure to disallowed medications may be eligible if there has been an interval of > 2 months off these medications.
- 4. Evidence of a large vessel stroke in a clinically relevant area (cerebral cortex, basal ganglia, thalamus) or mass lesion on structural brain imaging (MRI or CT).
- 5. Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.
- 6. Severe claustrophobia precluding MR or PET imaging. 7. Subjects limited by previous participation in research procedures involving ionizing radiation.
- 8. Pregnancy (test within 48 hours of each PET session) or breastfeeding 9. History of deep brain stimulation surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System Functional Neuroimaging, Cognitive and Mobility Laboratory
Ann Arbor, Michigan, 48106
About this study
Official title: Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease - Clin Core/Proj#2
Balance and gait problems cause severe impairments for people with Parkinson's disease In some Parkinson's disease patients the investigators see a loss of acetylcholine in the brain. In previous studies the investigators have shown that this loss of acetylcholine is related to impaired balance and gait function in Parkinson's disease. In this study the investigators will take a closer look at this finding.
Read the detailed description
Balance and gait problems cause severe impairments for people with Parkinson's disease and significantly affect their quality of life. Several changes occur in the brains of Parkinson's disease patients. The hallmark change is a loss of a neurotransmitter ("chemical messenger" between brain cells) called dopamine. To alleviate Parkinson's disease symptoms doctors prescribe dopamine replacement therapy, for example Sinemet (levodopa). Although effective for some of the symptoms, it typically does not sufficiently alleviate balance and gait problems. This study focuses on other changes in the brain that occur in Parkinson's disease that may contribute to balance and gait problems. In particular we will be looking at another neurotransmitter called acetylcholine. In some Parkinson's disease patients we see a loss of acetylcholine in the brain. In previous studies we have shown that this loss of acetylcholine is related to impaired balance and gait function in Parkinson's disease. In this study we will take a closer look at this finding.
- Conditions
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess change in balance and gait
motor tests are administered in an "off" state (by delaying the time at which the subject takes prescribed medication, subjects take their prescribed PD meds after the test battery, then tests are repeated one hour later in an "on" state. This is done at the initial study visit and at the 2 year follow up visit
Measured: data/testing is obtained at the initial visit and at a 2 year year follow up to note any changes in balance and gait
to assess change in memory and cognition
the same test battery of neuropsychology tests is administered at the initial study visit and at the 2 year follow up
Measured: data/testing obtained at the initial visit and at a 2 year follow up to note any changes for memory and cognition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study start5 Jan 2015
- Primary completionDec 2020
- Study completionDec 2020
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's 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
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, MD PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458430
- Sponsor's protocol ID
- HUM00093414
- Acronym
- UDALL
- Status last verified
- Feb 2021
- First submitted
- 18 Mar 2015
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barr J, Vangel R, Kanel P, Roytman S, Pongmala C, Albin RL, Scott PJH, Bohnen NI. Topography of Cholinergic Nerve Terminal Vulnerability and Balance Self-Efficacy in Parkinson's Disease. J Integr Neurosci. 2024 Sep 24;23(9):178. doi: 10.31083/j.jin2309178.
PubMed 39344233
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease - Clin Core/Proj#2
- ClinicalTrials.gov ID
- NCT02458430
- Acronym / sponsor ID
- UDALL / HUM00093414
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 5 Jan 2015
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 1 Jun 2015 (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.
Balance and gait problems cause severe impairments for people with Parkinson's disease In some Parkinson's disease patients the investigators see a loss of acetylcholine in the brain. In previous studies the investigators have shown that this loss of acetylcholine is related to impaired balance and gait function in Parkinson's disease. In this study the investigators will take a closer look at this finding.
Detailed description
Balance and gait problems cause severe impairments for people with Parkinson's disease and significantly affect their quality of life. Several changes occur in the brains of Parkinson's disease patients. The hallmark change is a loss of a neurotransmitter ("chemical messenger" between brain cells) called dopamine. To alleviate Parkinson's disease symptoms doctors prescribe dopamine replacement therapy, for example Sinemet (levodopa). Although effective for some of the symptoms, it typically does not sufficiently alleviate balance and gait problems. This study focuses on other changes in the brain that occur in Parkinson's disease that may contribute to balance and gait problems. In particular we will be looking at another neurotransmitter called acetylcholine. In some Parkinson's disease patients we see a loss of acetylcholine in the brain. In previous studies we have shown that this loss of acetylcholine is related to impaired balance and gait function in Parkinson's disease. In this study we will take a closer look at this finding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ago 50 and over
Key inclusion criteria (4 listed)
- Age 50 and above (M/F).
- PD diagnosis (with or without mild cognitive impairment; MCI) will follow the UK Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria for PD (47), consistent with the typical nigrostriatal denervation pattern on VMAT2. Absence of significant dementia confirmed by neuropsychological testing. Modified Hoehn and Yahr stages 1-4 (48, 49).
- PSP diagnosis will follow the NINDS-PSP clinical diagnostic criteria (50, 51).
- All PD subjects will be required to have nigrostriatal dopaminergic denervation as demonstrated by [11C]DTBZ PET imaging (52, 53). Subjects with Parkinsonism and absence of this PD-typical pattern will be re-categorized .
Key exclusion criteria (6 listed)
- 1. Presence of significant dementia. 2. Disorders which may resemble PD or PSP, such as dementia with Lewy bodies, vascular dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism. The use of the UKPDSBRC and NINDS-PSP clinical diagnostic criteria will mitigate the inclusion of patients with atypical parkinsonism.
- 3. Subjects on neuroleptic (except for low dose quetiapine 25-50 mg/d), anticholinergic (trihexyphenidyl, benztropine), cholinesterase inhibitors. Subjects with prior exposure to disallowed medications may be eligible if there has been an interval of > 2 months off these medications.
- 4. Evidence of a large vessel stroke in a clinically relevant area (cerebral cortex, basal ganglia, thalamus) or mass lesion on structural brain imaging (MRI or CT).
- 5. Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.
- 6. Severe claustrophobia precluding MR or PET imaging. 7. Subjects limited by previous participation in research procedures involving ionizing radiation.
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 assess change in balance and gait
Time frame: data/testing is obtained at the initial visit and at a 2 year year follow up to note any changes in balance and gait
motor tests are administered in an "off" state (by delaying the time at which the subject takes prescribed medication, subjects take their prescribed PD meds after the test battery, then tests are repeated one hour later in an "on" state. This is done at the initial study visit and at the 2 year follow up visit
to assess change in memory and cognition
Time frame: data/testing obtained at the initial visit and at a 2 year follow up to note any changes for memory and cognition
the same test battery of neuropsychology tests is administered at the initial study visit and at the 2 year 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 2 Mar 2021.
- Derived from this study: PubMed 39344233Barr J, Vangel R, Kanel P, Roytman S, Pongmala C, Albin RL, Scott PJH, Bohnen NI. Topography of Cholinergic Nerve Terminal Vulnerability and Balance Self-Efficacy in Parkinson's Disease. J Integr Neurosci. 2024 Sep 24;23(9):178. doi: 10.31083/j.jin2309178.
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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, MD PhD 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's 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 4 inclusion and 6 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 Mar 2021. 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 assess change in balance and gait (time frame: data/testing is obtained at the initial visit and at a 2 year year follow up to note any changes in balance and gait). The study lists 2 primary outcomes in all. 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 NCT02458430, 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 Mar 2021.