Parkinson's Disease Nervous System Diseases
Conditions
Interventions
Current interventions as of 05/12/2019:
Previous interventions:
600 participants with Parkinson’s disease will be enrolled from hospitals throughout the UK. Participants will be randomly assigned to
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 05/07/2019: 1. Diagnosis of idiopathic Parkinson’s disease 2. Modified Hoehn and Yahr stage 1-4 disease 3. Have experienced a fall in the previous year 4. Able to walk =10m without aids or assistance 5. 18 years of age or above Previous participant inclusion criteria: 1. Diagnosis of idiopathic Parkinson’s disease 2. Modified Hoehn and Yahr stage 1-4 disease 3. Have experienced a fall in the previous year 4. Able to walk =10m without aids or assistance
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 05/07/2019: 1. Previous ChEi use in 12 months prior to enrolment. 2. Hypersensitivity to rivastigmine 3. Dementia diagnosed according to Movement Disorder Society (MDS) criteria 4. Inability to attend or comply with treatment or follow-up scheduling 5. Non-English-speaking patients (cognitive tests performed in English) 6. Falling = 4x per day 7. Unwillingness to use an acceptable method of contraception for the duration of the trial if they are of childbearing potential 8. Pregnant of breast feeding Previous participant exclusion criteria: 1. Previous ChEi use in 12 months prior to enrolment 2. Hypersensitivity to rivastigmine 3. Dementia diagnosed according to Movement Disorder Society (MDS) criteria 4. Inability to attend or comply with treatment or follow-up scheduling 5. Non-English-speaking patients (cognitive tests performed in English) 6. Falling = 4x per day 7. Unwillingness to use an acceptable method of contraception for the duration of the trial if they are of childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fall rate measured using monthly diaries and telephone calls prospectively over 12 months from the day the IMP is commenced. A fall is defined as “unintentionally coming to rest on the ground or other lower surface without overwhelming external force or a major internal event” | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/12/2019: 1. Parkinson's Disease markers assessed via the MDS-UPDRS total score in the practically defined ON state and each individual subscale (1-4) measured at baseline and 12months 2. Freezing of gait assessed via the New Freezing Of Gait Questionnaire (NFOGQ) measured at baseline and 12months 3. Frailty and physical performance assessed via Short Physical Performance Battery (SPPB), gait speed and frailty status measured at baseline and 12months 4. Cognition assessed via Montreal Cognitive Assessment (MoCA) measured at baseline and 12months 5. Depression assessed via Geriatric Depression Scale (GDS) measured at baseline and 12months 6. Apathy assessed via the Starkstein Apathy Scale (SAS) 7. Fear of falling assessed via the Iconographical Fall Efficacy Scale (ICON-FES) measured at baseline and 12months 8. Dysphagia assessed via the Swallowing Disturbance Questionnaire (SDQ) measured at baseline and 12months 9. Participant health-related quality of life assessed via the EuroQoL 5D-5L health status questionnaire (EQ-5D-5L) measured at baseline, 1 month, 3 months, 6 months, 9 months and 12months 10.Capability of older people assessed via the ICEpop CAPability measure for Older people (ICECAP-O) measured at baseline and 12 months 11. Mortality (all cause and PD related) through Office of National Statistics measured at 12months 12. Cost-effectiveness and NHS resource use through EQ-5D-5L and NHS Episode Statistics (HES) data Secondary outcome via CHIEF-PD carer study: 12. Care-related quality of life via the Carer Experience Scale (CES) measured at baseline and 12months _____ Previous secondary outcome measures: 1. Parkinson's Disease markers assessed via the MDS-UPDRS total score in the practically defined ON state and each individual subscale (1-4) measured at baseline and 12months 2. Freezing of gait assessed via the New Freezing Of Gait Questionnaire (NFOGQ) measured at baseline and 12months 3. Frailty and physical | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed