Clinical Laboratory Evaluation of Chronic Autonomic Failure
NCT03648905
Autonomic Failure, Autonomic Nervous System Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT02881099
Prospective observational study of Parkinson's disease with repeat clinical assessment and biobanking of blood samples.
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Notify Me18 year–90 year
All sexes
Observational
To identify genetic and biomarker factors which affect the expression of Parkinson's Disease.
Primary objective: To define the severity and rates of progression of clinical features of Parkinson's Disease.
Secondary objective: To relate clinical phenomenology of Parkinson's disease to genetic and biomarker changes.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
A. Parkinson's Disease patients
Inclusion criteria
Exclusion criteria
B. First degree relatives Inclusion criteria
Exclusion criteria
Time frame: Up to 36 months
Genotyping for leucine rich repeat kinase 2 (LRRK2), Glucocerebrosidase (GBA) (all cases) and Parkin, Phosphatase and tensin homolog-induced putative kinase 1 (PINK1)(onset<50years)
Time frame: At 4 years
Clustering of motor and non-motor features measured using Movement Disorder Society Unified Parkinson's disease rating scale (MDS-UPDRS), Montréal cognitive assessment (MoCA), Non-motor symptom Scale (NMSS), Scale for outcomes in Parkinson's autonomic (SCOPA-AUT), Olfaction testing using University of Pennsylvania Smell Identification Test (UPSIT) or Sniffin' sticks, and Leeds anxiety and depression scale (LADS).
This will use sequential factor analysis of the results of the above assessments, followed established methods, firstly exploratory factor analysis and secondly confirmatory factor analysis. Factor scores and other clinically important variables will then be combined to construct a single dataset for carrying out the cluster analysis. Hierarchical clustering will then be applied, and models with between 2 and 5 clusters will be described and compared.
Time frame: At 4 years
Prior history of vascular events, or calculated using Quantification of Risk version 2 (QRISK2) vascular risk score
South Glasgow University Hospitals NHS Trust
Other
Acronym: PRoBaND
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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