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Research participants for Parkinson's Disease

N/A
Recruiting
Led By Michael Howell, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time point 1 (baseline) and time point 2 (24 months, +/- 3 months)
Awards & highlights
No Placebo-Only Group

Summary

This project will test the hypotheses that people with 5-HT RBD have systemic alpha- synuclein pathology, prodromal DLB signs, and brainstem lesions in regions that control REM sleep. AIM 1 will seek to detect abnormally phosphorylated alpha- synuclein aggregates on targeted skin biopsy in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD). Aim 2 will use ultra-high field MRI at 7T to examine the pontine region of the coeruleus/subcoeruleus complex for evidence of neurodegeneration as well as segment and parcellate REM sleep related neuronal structures. Aim 3 will test for speech deficits. While these aims are independent we suspect that the severity of autonomic, speech and cognitive deficits will correlate with loss of neuromelanin signal on MRI and pathology on skin biopsy. The investigation is a longitudinal designed study to examine histopathology, neuroimaging changes and speech function from baseline (Time 1) to a follow-up after 30 months (Time 2). A total of 60 individuals, 30 with 5-HT RBD and 30 controls, will be recruited at Time 1, brought back at Time 2, and tested across all Aims at both study visits.

Eligible Conditions
  • Parkinson's Disease
  • REM Sleep Behavior Disorder
  • Dementia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time point 1 (baseline) and time point 2 (24 months, +/- 3 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time point 1 (baseline) and time point 2 (24 months, +/- 3 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Monopitch as measured by fundamental frequency variability.
Neuromelanin signal intensity in the Subcoeruleus/Coeruleus Complex
Phosphorylated alpha synuclein deposits on skin biopsy
Secondary study objectives
Speed of articulatory change as measured by F2 Transitions
Subject-specific masks of all REM sleep-related pontine nuclei of interest, volume of Subcoeruleus/Coeruleus Complex.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Research participantsExperimental Treatment3 Interventions
Adults under the age of 75; who do not meet criteria for Parkinson's disease, dementia with Lewy bodies, Alzheimer's disease, other diagnosed neurodegenerative disorder, or other known cause of RBD; and have a history of or currently use the SSRIs of interest.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Skin biopsy
2021
Completed Phase 4
~980

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,420 Previous Clinical Trials
1,618,142 Total Patients Enrolled
Michael Howell, MDPrincipal InvestigatorUniversity of Minnesota
~40 spots leftby Sep 2028