We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease (UDALL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02458430
Recruitment Status : Completed
First Posted : June 1, 2015
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Nicolaas Bohnen, MD, PhD, University of Michigan

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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.

Condition or disease
Parkinson's Disease

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease - Clin Core/Proj#2
Study Start Date : January 5, 2015
Actual Primary Completion Date : December 2020
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
Saliva and Blood

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Ago 50 and over
Criteria

Inclusion Criteria:

  1. Age 50 and above (M/F).
  2. 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).
  3. PSP diagnosis will follow the NINDS-PSP clinical diagnostic criteria (50, 51).
  4. 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 .

Exclusion Criteria:

  • 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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458430


Locations
Layout table for location information
United States, Michigan
University of Michigan Health System Functional Neuroimaging, Cognitive and Mobility Laboratory
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
Layout table for investigator information
Principal Investigator: Nicolaas Bohnen, MD PhD University of Michigan
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Nicolaas Bohnen, MD, PhD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT02458430    
Other Study ID Numbers: HUM00093414
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases