Synucleinopathies

Overview

About this study

The goals of the study are to prospectively evaluate clinical and laboratory biomarkers of multiple system atrophy and Parkinson’s disease at early clinical disease, at a premotor stage (PAF), and even at a prodromal stage (RBD).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Males or females aged 30-80 years.
  • Participants who are willing and able to give informed consent.
  • “Normal” cognition as assessed by MMSE. We will require a value > 24.
  • MSA patients fulfill the following criteria:
    • Fulfill Consensus Criteria 3, 4 for possible or probable MSA;
    • UMSARS I (minus question 11) between 5-16 and able to walk unaided;
    • Anticipated survival of at least 3 years in the opinion of the investigator.
  • PD patients at Hoehn and Yahr stage 2 to 3
  • Healthy controls without evidence of neurologic disease or autonomic dysfunction.
  • iRBD patients with sleep-study confirmed RBD by International Classification of Sleep Disorders V3 criteria, with absence of a diagnosis of dementia, PD, MSA, or other overt neurodegenerative disease.

Exclusion Criteria:

  • Pregnant or breastfeeding women, and women of childbearing potential who do not practice an acceptable method of birth control.
  • Participants with a clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion of the study or might affect the results of the study.
  • Participants who have taken any investigational products within 60 days prior to baseline.
  • Medications that could affect autonomic function are permitted but need to be withdrawn at least four half-lives prior to autonomic evaluations.
  • Patients with contraindication for MRI scanning, including those with MRI-incompatible pacemakers.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/28/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wolfgang Singer, M.D.

Open for enrollment

Contact information:

Tonette Gehrking CAP

(507) 284-0336

adc.research@mayo.edu

More information

Publications

Publications are currently not available