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| Name | Class |
|---|---|
| Royal United Hospitals Bath NHS Foundation Trust | OTHER |
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Parkinson's disease is a common condition particularly affecting older people. Falls are a very frequent complication of the disease affecting 60% of people with Parkinson's every year. As the population ages, the number of people living with Parkinson's disease and the occurrence of complications will increase. The loss of the chemical dopamine in the brain causes walking in Parkinson's to become slower, unsteady and irregular. People with the condition are therefore at a very high risk of falling. To some extent, people can compensate for these changes by paying more attention to their walking. However, Parkinson's also diminishes memory and thinking ability. This decreases people's ability to pay attention to their walking, especially when doing something at the same time.
Cholinesterase inhibitor (ChEis) are drugs that are currently used to treat people with memory problems in Parkinson's. The effect of these drugs on falls in Parkinson's has been tested to show that treatment has the potential to almost halve the number of falls.
This trial aims to definitively determine whether cholinesterase inhibitors (ChEi), can prevent falls in Parkinson's and whether this treatment is cost effective. 600 participants with Parkinson's disease will be enrolled from hospitals throughout the UK. Participants will be randomly assigned to either receive the drug (ChEi) via a patch or receive a placebo (dummy) treatment via a patch.
Neither the researchers nor the participants will know which group they are in. Participants will take the medication for 12 months and record any falls that they experience in diaries. If successful, this treatment in Parkinson's disease, would tackle one of the most disabling complications of the disease and positive findings will provide robust evidence to change clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active (Rivastigmine) | Active Comparator | Rivastigmine Transdermal Patches |
|
| Placebo | Placebo Comparator | Placebo Matched Transdermal Patches |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine Transdermal System | Drug | Rivastigmine Trandermal Patches applied once a day for up to 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fall rate | Fall rate measured using monthly diaries and telephone calls prospectively | 12 months from the day the IMP is commenced |
| Measure | Description | Time Frame |
|---|---|---|
| Parkinson's Disease (PD) | MDS-UPDRS total score in the practically defined 'ON' state and each individual subscale (1-4) | 12 months |
| Freezing of gait | New Freezing of Gait Questionnaire (NFOGQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Henderson, PhD | University of Bristol | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barking, Havering and Redbridge University Hospitals NHS trust | Romford | Accepted | BS8 1NU | United Kingdom | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34715821 | Derived | Neumann S, Taylor J, Bamford A, Metcalfe C, Gaunt DM, Whone A, Steeds D, Emmett SR, Hollingworth W, Ben-Shlomo Y, Henderson EJ. Cholinesterase inhibitor to prevent falls in Parkinson's disease (CHIEF-PD) trial: a phase 3 randomised, double-blind placebo-controlled trial of rivastigmine to prevent falls in Parkinson's disease. BMC Neurol. 2021 Oct 29;21(1):422. doi: 10.1186/s12883-021-02430-2. |
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A Phase III Randomised Controlled Trial of Rivastigmine versus Placebo
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Double blind
| Placebo Transdermal System | Other | Placebo Trandermal Patches applied once a day for up to 12 months |
|
| 12 months |
| Frailty | Frailty assessed by the SHARE-FI | 12 months |
| Physical performance | Measured by the Short physical performance battery (SPPB) | 12 months |
| Freezing of Gait Assessment | Gait speed measured with Freezing of Gait (turn test) | 12 months |
| Gait Assessment | Gait speed measured with and without dual task | 12 months |
| Cognition | Montreal Cognitive Assessment (MoCA) | 12 months |
| Depression | Geriatric Depression Scale (GDS) | 12 months |
| Fear of falling | Iconographical Fall Efficacy Scale (ICON-FES) | 12 months |
| Dysphagia | Swallowing Disturbance Questionnaire (SDQ) | 12 months |
| Participant health related quality of life | EuroQoL 5D-5L health status questionnaire (EQ-5D-5L) | 0,1,3,6 9 and 12 months |
| Capability of older people | ICEpop CAPability measure for Older people (ICECAP-O) | 12 months |
| Mortality (all cause and PD-related) | Office of National Statistics (ONS) data | 12 months |
| Cost effectiveness by NHS resource use | NHS Hospital Episode Statistics (HES) data | 12 months |
| Apathy | Starkstein Apathy Scale | 12 months |
| Manchester University NHS Foundation Trust |
| Manchester |
| England |
| M13 9WL |
| United Kingdom |
| Betsi Cadwaladr University Health Board | Bangor | Gwynedd | LL57 2PW | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | Norfolk | NR4 7UY | United Kingdom |
| Lothian Health Board NHS | Edinburgh | Scotland | EH1 3EG | United Kingdom |
| NHS Forth Valley | Larbert | Scotland | FK5 4WR | United Kingdom |
| Royal United Hospitals Bath NHS Foundation Trust | Bath | Somerset | BA1 3NG | United Kingdom |
| NHS Grampian | Aberdeen | AB15 6RE | United Kingdom |
| Barnsley Hospital NHS Foundation Trust | Barnsley | S75 2EP | United Kingdom |
| University Hospitals Dorset NHS Foundation Trust | Bournemouth | BH23 2JX | United Kingdom |
| Princess of Wales Hospital (Cwm Taf Morgannwg University Health Board) | Bridgend | CF31 1RQ | United Kingdom |
| University Hospitals Bristol and Weston NHS Foundation Trust | Bristol | BS1 3NU | United Kingdom |
| North Bristol NHS Trust | Bristol | BS10 5NB | United Kingdom |
| Pennine Acute Hospitals NHS Trust | Bury | BL9 7TD | United Kingdom |
| University Hospitals of Derby and Burton NHS Foundation Trust | Derby | DE22 3NE | United Kingdom |
| NHS Tayside | Dundee | DD2 1UB | United Kingdom |
| Gateshead Health NHS Foundation Trust | Gateshead | NE9 6SX | United Kingdom |
| Gloucestershire Hospitals NHS Foundation Trust | Gloucester | GL1 3NN | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | LS2 3AX | United Kingdom |
| University Hospitals of Leicester NHS Foundation Trust | Leicester | LE1 5WW | United Kingdom |
| The Walton Centre NHS Foundation Trust | Liverpool | L9 7LJ | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W6 8RF | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | WC1N 3BG | United Kingdom |
| South Tees Hospitals NHS Foundation Trust | Middlesbrough | TS4 3BS | United Kingdom |
| Northumbria Healthcare NHS Foundation Trust | Newcastle | NE27 0QJ | United Kingdom |
| Newcastle Hospitals NHS Foundation Trust | Newcastle | NE7 7DN | United Kingdom |
| Aneurin Bevan University Health Board | Newport | NP18 3XQ | United Kingdom |
| Oxford University Hospitals | Oxford | OX3 9DU | United Kingdom |
| North West Anglia NHS Foundation Trust | Peterborough | PE3 9GZ | United Kingdom |
| University Hospitals Plymouth NHS Trust | Plymouth | PL6 5FP | United Kingdom |
| Lancashire Teaching Hospitals NHS Foundation Trust | Preston | PR2 9HT | United Kingdom |
| Royal Berkshire NHS Foundation Trust | Reading | RG1 5AN | United Kingdom |
| Salford Royal NHS Foundation Trust | Salford | MA6 8HD | United Kingdom |
| North Tees and Hartlepool Hospitals NHS Foundation Trust | Stockton-on-Tees | TS19 8PE | United Kingdom |
| Somerset NHS Foundation Trust | Taunton | TA1 5DA | United Kingdom |
| Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust | Wigan | WN1 2NN | United Kingdom |
| Betsi Cadwaladr University Health Board | Wrexham | LL13 7YP | United Kingdom |
| Yeovil District Hospital | Yeovil | United Kingdom |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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