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

NCT05459753 | Active Not Recruiting DMC

• 2 other identifiers: HUM001975901P50NS123067-01
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Progressive Supranuclear Palsy

Keywords

Parkinson's Disease; Parkinson; Parkinson's; Freezing of Gait; FOG; PIGD

Outcome Measures

Primary Outcomes (3)

• Interval change on the Unified Parkinson's disease rating scale (UPDRS) motor rating scale over a 2-yr period

  Interval change baseline vs 2-yr follow-up on the UPDRS motor score. UPDRS motor section is scored from 0-132, with higher scores indicating more severe motor symptoms.

  At Baseline and at 2-year follow up

• Cholinergic brain PET FEOBV PET distribution volume ratio (DVR) interval change over a 2-yr period

  Interval change baseline vs 2-yr follow in cholinergic brain FEOBV PET DVR

  At Baseline and at 2-year follow up

• Cognitive 2-yr interval change on the Montreal Cognitive Assessment (MoCa) cognitive scale

  Interval change baseline vs 2-yr follow-up on the Montreal Cognitive Assessment (MoCa) cognitive scale. The MoCa is scored out of 30, with higher scores indicating better cognition.

  At Baseline and at 2-year follow up

Study Arms (1)

Parkinson's Disease

EXPERIMENTAL

Individuals with idiopathic Parkinson's disease.

Radiation: (18)F]fluoroethoxybenzovesamicol ([(18)F (FEOBV) PET; Radiation: Dihydrotetrabenazine (DTBZ) PET

Interventions

(18)F]fluoroethoxybenzovesamicol ([(18)F (FEOBV) PET RADIATION

Participants will receive an injection of 8 mCi \[18F\]FEOBV PET tracer and undergo a CT of the head.

Parkinson's Disease

Dihydrotetrabenazine (DTBZ) PET RADIATION

Participants will receive an injection of 15 mCi \[11C\]DTBZ PET tracer and undergo a CT of the head.

Parkinson's Disease

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Michigan - Michigan Medicine

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

MeSH Terms

Conditions

Parkinson Disease; Supranuclear Palsy, Progressive

Interventions

Fluorine-18; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; dihydrotetrabenazine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roger Albin, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 15, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (1)