A Pilot Biomarker Study Assessing Alpha-synuclein Aggregates Across Biofluid Reservoirs in Patien… (NCT04020198) | Clinical Trial Compass
TerminatedNot Applicable
A Pilot Biomarker Study Assessing Alpha-synuclein Aggregates Across Biofluid Reservoirs in Patients With Synucleinopathies
Stopped: The assay under investigation did not show evidence of accurately detecting alpha-synuclein in specimens collected in the study other than CSF and the intention of the study was to identify less invasive ways to measure alpha-synuclein.
United States8 participantsStarted 2020-01-15
Plain-language summary
This will be an observational study looking at clinical and biomarker characteristics in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Rapid Eye Movement Sleep Behavior Disorder (RBD), Normal Pressure Hydrocephalus and matched controls. Saliva, plasma, serum, urine, and cerebrospinal fluid (CSF) samples will be collected from participants.
Who can participate
Age range50 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 50-75
✓. Diagnosis of idiopathic PD as confirmed by a movement disorder specialist
✓. Age of onset of motor symptoms between 50 - 75
✓. Well-established response to dopaminergic agents and/or amantadine
✓. Ability to complete questionnaires
✓. Ability to provide informed consent
✓. Willingness to go off parkinsonian medication for 12 hours prior to "off" assessment
✓. Medical record includes a brain MRI taken within the past 12 months showing no evidence of a tumor or abscess
Exclusion criteria
✕. Symptomatic (secondary) parkinsonism (ie. drug induced)
✕. Atypical parkinsonian variants
✕
What they're measuring
1
Compare levels of misfolded alpha-synuclein aggregates in participants with PD, MSA, RBD, NPH and controls