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Study identifier: NCT05459753 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Active Not Recruiting

Cholinergic Mechanisms of Attentional-motor Integration and Gait Dysfunction in Parkinson Disease (UDALL)

Condition: Parkinson Disease · Progressive Supranuclear Palsy  ·  Sponsor: University of Michigan

PhaseNA
Planned participants125
Who can joinAll sexes, 21 Years to no upper limit
Healthy volunteersYesCheck eligibility criteria ↓
WhereAnn Arbor, Michigan, United States

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About this study

To perform a prospective cohort study with \[(18)F\]fluoroethoxybenzovesamicol (FEOBV) brain PET at baseline and 2-year follow-up in PD subjects at risk of conversion to non-episodic and episodic (falls and FoG) PIGD motor features and cognitive changes at the same time points.

This description comes directly from the study's public registry record.

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No contact information is available for this study as per the public registry record.

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Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * Age ≥21 for normal control subjects (Male/Female) and ≥45 for Parkinson's disease (PD), Progressive supranuclear palsy (PSP), or Alzheimer's disease (AD) participants (Male/Female). * For normal control subjects, no significant neurological or psychiatric symptoms and normal neuropsychological examination for age. * PD diagnosis (with or without Mild Cognitive Impairment/dementia) will follow the Movement Disorder Society-revised clinical diagnostic criteria for PD or Parkinson-PSP patients. * Modified Hoehn and Yahr stages 1-4. * AD subjects meeting the criteria listed in Guy M. McKhann et al. * All PD subjects are required to have nigrostriatal dopaminergic denervation as demonstrated by vesicular monoaminergic transporter type-2 (VMAT) \[18F\]9-fluoropropyl-(+)-dihydrotetrabenazine (DTBZ) positron emission tomography (PET) imaging. This may be based on a prior DTBZ PET scan or the DTBZ PET scan performed as part of this study. Exclusion Criteria: * Disorders which may resemble PD, 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 Movement Disorder Society-revised clinical diagnostic criteria will mitigate the inclusion of PD subjects with atypical parkinsonism. * Subjects on neuroleptic, anticholinergic (trihexyphenidyl, benztropine), or cholinesterase inhibitor drugs. Subjects with prior exposure to disallowed medications may be eligible if there has been an interval of \> 2 months off these medications.\*\* Note that patients on pimavanserin will be eligible. * 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 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.\*\* * Subjects limited by previous participation in research procedures involving ionizing radiation.\*\* * Pregnancy (test within 48 hours of each PET session) or breastfeeding.\*\* * History of deep brain stimulation surgery.\*\* * Suicidality (responses 2 or 3 for question 9 on the Beck Depression Inventory). * Subjects from the previous U-M Udall Center cohort who have developed a contraindication for neuroimaging procedures (Exclusion criteria #4 - #9) or have started taking cholinergic medications (Exclusion criterion #3) will be eligible to continue their participation in clinical assessments but will not be referred to neuroimaging assessments.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (1)

University of Michigan - Michigan MedicineAnn Arbor, Michigan, United States

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