CHIEF PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease)

Parkinson Disease Clinical Trial

— CHIEF PD  

Official title:

CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease: A Phase 3 Randomised, Double-blind Placebo-controlled Trial of Rivastigmine to Prevent Falls in Parkinson's Disease.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04226248
• Other study ID #: Study 2018-2030
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 2, 2020
• Est. completion date: April 26, 2024

Study information

• Verified date: November 2023
• Source: University of Bristol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: April 26, 2024
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of idiopathic Parkinson's disease.

• Modified Hoehn and Yahr stage 1-4 disease as determined at baseline visit.

• Have experienced a fall in the previous year.

• Able to walk =10m without aids or assistance.

• 18+ years of age.

Exclusion Criteria:

• Previous ChEi use in 12 months prior to enrolment.

• Hypersensitivity to rivastigmine

• Dementia diagnosed according to MDS criteria (6).

• Inability to attend or comply with treatment or follow-up scheduling.

• Non-English-speaking patients (cognitive tests performed in English).

• Falling =4x per day.

• Unwillingness to use an acceptable method of contraception for the duration of the trial if they are of childbearing potential.

• Pregnancy and/or breastfeeding

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Rivastigmine Transdermal System
Rivastigmine Trandermal Patches applied once a day for up to 12 months

Other:
• Placebo Transdermal System
Placebo Trandermal Patches applied once a day for up to 12 months

Locations

Country	Name	City	State
United Kingdom	NHS Grampian	Aberdeen
United Kingdom	Betsi Cadwaladr University Health Board	Bangor	Gwynedd
United Kingdom	Barnsley Hospital NHS Foundation Trust	Barnsley
United Kingdom	Royal United Hospitals Bath NHS Foundation Trust	Bath	Somerset
United Kingdom	University Hospitals Dorset NHS Foundation Trust	Bournemouth
United Kingdom	Princess of Wales Hospital (Cwm Taf Morgannwg University Health Board)	Bridgend
United Kingdom	North Bristol NHS Trust	Bristol
United Kingdom	University Hospitals Bristol and Weston NHS Foundation Trust	Bristol
United Kingdom	Pennine Acute Hospitals NHS Trust	Bury
United Kingdom	University Hospitals of Derby and Burton NHS Foundation Trust	Derby
United Kingdom	NHS Tayside	Dundee
United Kingdom	Lothian Health Board NHS	Edinburgh	Scotland
United Kingdom	Gateshead Health NHS Foundation Trust	Gateshead
United Kingdom	Gloucestershire Hospitals NHS Foundation Trust	Gloucester
United Kingdom	NHS Forth Valley	Larbert	Scotland
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	University Hospitals of Leicester NHS Foundation Trust	Leicester
United Kingdom	The Walton Centre NHS Foundation Trust	Liverpool
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	University College London Hospitals NHS Foundation Trust	London
United Kingdom	Manchester University NHS Foundation Trust	Manchester	England
United Kingdom	South Tees Hospitals NHS Foundation Trust	Middlesbrough
United Kingdom	Newcastle Hospitals NHS Foundation Trust	Newcastle
United Kingdom	Northumbria Healthcare NHS Foundation Trust	Newcastle
United Kingdom	Aneurin Bevan University Health Board	Newport
United Kingdom	Norfolk and Norwich University Hospital	Norwich	Norfolk
United Kingdom	Oxford University Hospitals	Oxford
United Kingdom	North West Anglia NHS Foundation Trust	Peterborough
United Kingdom	University Hospitals Plymouth NHS Trust	Plymouth
United Kingdom	Lancashire Teaching Hospitals NHS Foundation Trust	Preston
United Kingdom	Royal Berkshire NHS Foundation Trust	Reading
United Kingdom	Barking, Havering and Redbridge University Hospitals NHS trust	Romford	Accepted
United Kingdom	Salford Royal NHS Foundation Trust	Salford
United Kingdom	North Tees and Hartlepool Hospitals NHS Foundation Trust	Stockton-on-Tees
United Kingdom	Somerset NHS Foundation Trust	Taunton
United Kingdom	Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust	Wigan
United Kingdom	Betsi Cadwaladr University Health Board	Wrexham
United Kingdom	Yeovil District Hospital	Yeovil

Sponsors (2)

Lead Sponsor	Collaborator
University of Bristol	Royal United Hospitals Bath NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fall rate	Fall rate measured using monthly diaries and telephone calls prospectively	12 months from the day the IMP is commenced
Secondary	Parkinson's Disease (PD)	MDS-UPDRS total score in the practically defined 'ON' state and each individual subscale (1-4)	12 months
Secondary	Freezing of gait	New Freezing of Gait Questionnaire (NFOGQ)	12 months
Secondary	Frailty	Frailty assessed by the SHARE-FI	12 months
Secondary	Physical performance	Measured by the Short physical performance battery (SPPB)	12 months
Secondary	Freezing of Gait Assessment	Gait speed measured with Freezing of Gait (turn test)	12 months
Secondary	Gait Assessment	Gait speed measured with and without dual task	12 months
Secondary	Cognition	Montreal Cognitive Assessment (MoCA)	12 months
Secondary	Depression	Geriatric Depression Scale (GDS)	12 months
Secondary	Fear of falling	Iconographical Fall Efficacy Scale (ICON-FES)	12 months
Secondary	Dysphagia	Swallowing Disturbance Questionnaire (SDQ)	12 months
Secondary	Participant health related quality of life	EuroQoL 5D-5L health status questionnaire (EQ-5D-5L)	0,1,3,6 9 and 12 months
Secondary	Capability of older people	ICEpop CAPability measure for Older people (ICECAP-O)	12 months
Secondary	Mortality (all cause and PD-related)	Office of National Statistics (ONS) data	12 months
Secondary	Cost effectiveness by NHS resource use	NHS Hospital Episode Statistics (HES) data	12 months
Secondary	Apathy	Starkstein Apathy Scale	12 months