Parkinson's disease Nervous System Diseases
Conditions
Interventions
Participants will be persons living with Parkinson’s disease (PD) and healthy unrelated volunteers (controls). In addition, caregivers of people with PD (PwP) will participate alongside the PwP for th
Sponsors
Newcastle University
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: A. Prevalence study: 1. Participant resident in the delineated community for at least 12 months prior to the date of survey 2. Age 18 years or older B. Other clinical studies (including clinical trial): Persons with PD 1. Participant diagnosed with PD based on UKPD brain bank clinical criteria 2. Age 18 years or older 3. Consent to participate obtained 4. Any stage of PD 5. Either treatment naive (only for mucuna prurens trial) or on treatment (any study component) B. Healthy control: 1. Neurologically normal (assessed at in-person physical examination) 2. Age 18 years or older 3. Consent to participate
Exclusion criteria
Exclusion criteria: 1. Non consent/lacking capacity 2. Physically unable to complete study procedures due to advanced disease and physical disability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Prevalence study: Prevalence of PD will be measured using the community-based parkinsonism screening interview and second stage physician verified diagnosis of PD and reported as Number of persons with PD per 100,000 population. Data will be age-adjusted to the WHO World population. 2. Environmental risk factor assessments: Environmental risk factors for PD will be measured at baseline using (i) toxicology assessment for contaminants of emerging concern related to PD (including pesticides, herbicides, other chemicals and heavy metals) in the soil and water samples at residences of PwP versus healthy volunteers and (ii) Comparison of the risk exposures of PwP and controls based on responses in the NINDS CDE MERQ and PD RFQ questionnaires and reported as the relative risk of exposure for each subcategory of risk factors interrogated. 3. Metabolome studies (conducted at baseline) primary outcome will be the diagnostic utility of skin metabolites measured in sebum in differentiating PwP from controls. 4. Microbiome studies (conducted at baseline) primary outcome will be the differences in the gut and oral microbiome composition in PwP and controls measured using microbiota data on alpha diversity, beta diversity, differential abundance of microbial taxa and functional gene analysis in PwP compared to controls. 5. Mucuna pruriens clinical trial: the primary outcome will be the efficacy of M. pruriens compared to levodopa/carbidopa measured by degree of change in the MDS-UPDRS Motor (Part III) scores at baseline (time point 0 i.e. treatment naive compared to 12 months on treatment. 6. Diagnostic aids and Treatment aids: The primary outcome measure of these devices/aids will be the diagnostic utility and/or performance in PwP (compared to controls where relevant). The diagnostic aids and treatment aids related to this outcome and the measures relevant to them are as follows: Gait (wearable technology for measuring gait in PD), Neuromotor Pen ® (diagnosis of bradyki | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Phenotypic characterization of Parkinson’s disease will be assessed at baseline using the validated measures described in the methodology, including the MDS-UPDRS (PD severity and stage), Cognitive function (MoCA and IDEA), non-motor symptoms burden (MDS NMSQ), quality of life (PDQ8), REM sleep behavioural disorder (RBDQ), autonomic symptomatology (SCOPA-AUT), and reported as secondary outcomes (frequency of phenotypic characteristics, motor phenotype of PD, frequency of cognitive dysfunction, autonomic dysfunction, impulsivity, hyposmia, REM sleep behavioural disorder), health-related QOL (PDQ 8 summary scores and derivation) and Barthel activities of daily living (ADL) scale (summary scores). 2. Cost effectiveness of Mucuna pruriens as a treatment for PD in Africa (comparative analysis versus cost of equivalent dose of levodopa therapy) over a 12-month period | — |
Countries
Egypt, Ethiopia, Ghana, Kenya, Nigeria, South Africa, Tanzania
Outcome results
None listed