Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease

NCT02458430 | Completed

• 1 other identifier: HUM00093414
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• 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

  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

  data/testing obtained at the initial visit and at a 2 year follow up to note any changes for memory and cognition

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ago 50 and over

You may qualify if:

• 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 .

You may not qualify if:

• \. 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.
• \. 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).
• \. 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.
• \. Severe claustrophobia precluding MR or PET imaging. 7. Subjects limited by previous participation in research procedures involving ionizing radiation.
• \. Pregnancy (test within 48 hours of each PET session) or breastfeeding 9. History of deep brain stimulation surgery.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Health System Functional Neuroimaging, Cognitive and Mobility Laboratory

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (1)

• 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.

  PMID: 39344233 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and Blood

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Nicolaas Bohnen, MD PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: June 1, 2015
• Study Start: January 5, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 2, 2021

Record last verified: 2021-02

Locations

US (1)