Clinical Trials

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.