A Study to Create a Diagnostic Test for Patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-002518
NCT ID: NCT04700722
About this study
The purpose of this study is to develop a diagnostic test using tissue biomarkers to provide an accurate diagnosis of alpha-synucleinopathies in patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure. Using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguishing between neurodegenerative diseases.
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 - Synucleinopathy Subjects:
- Men and women, age 40 to 99 years.
- Willing to undergo a screening evaluation that includes a thorough medical history, physical and neurologic examination.
- Clinically established diagnosis of Parkinson’s disease, multiple system atrophy, dementia with Lewy bodies, pure autonomic failure, or a subject considered a healthy control at enrollment.
- No subjects where the clinician is uncertain of the diagnosis should be enrolled in this study.
- Diagnosis of Parkinson’s disease by UKPDS Brain Bank Criteria (Hughes 1992).
- Diagnosis of multiple system atrophy by the Gilman Criteria (Gilman 2008).
- Diagnosis of dementia with Lewy bodies by the 4th consensus on DLB consortium criteria (McKeith 2017).
- Diagnosis of pure autonomic failure by chronic orthostatic hypotension (> 1 year) with a fall in systolic blood pressure > 30 mmHg from supine to standing position within 3 minutes.
- Either absent phase 4 on Valsalva maneuver or at least 1 additional organ system involved (bowel, bladder).
Inclusion Criteria - Healthy Subjects:
- Men and women, age 40 to 99 years.
- Willing to undergo a screening evaluation that includes a thorough medical history, physical and neurologic examination.
- Healthy subject with no history of clinical exam or symptoms suggestive of synucleinopathy.
Exclusion Criteria:
- Subjects with evidence of RBD by history or questionnaire.
- Individuals with a history or exam finding suggestive of anosmia, urinary dysfunction or chronic constipation.
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Wolfgang Singer, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available