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

Phase 3

Active, not recruiting

• Conditions: Parkinson Disease
• Interventions: Drug: Rivastigmine Transdermal System; Other: Placebo Transdermal System

• Registration Number: NCT04226248
• Lead Sponsor: University of Bristol

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-05
• Study Start: 2020-01-02
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Primary Completion: 2024-05-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active (Rivastigmine)	Rivastigmine Transdermal System	Rivastigmine Transdermal Patches
Placebo	Placebo Transdermal System	Placebo Matched Transdermal Patches

Primary Outcome Measures

Name	Time	Method
Fall rate	12 months from the day the IMP is commenced	Fall rate measured using monthly diaries and telephone calls prospectively

Secondary Outcome Measures

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

Trial Locations

Locations (37)

Barking, Havering and Redbridge University Hospitals NHS trust; 🇬🇧 Romford, Accepted, United Kingdom

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, England, United Kingdom

Betsi Cadwaladr University Health Board; 🇬🇧 Wrexham, United Kingdom

Norfolk and Norwich University Hospital; 🇬🇧 Norwich, Norfolk, United Kingdom

Lothian Health Board NHS; 🇬🇧 Edinburgh, Scotland, United Kingdom

NHS Forth Valley; 🇬🇧 Larbert, Scotland, United Kingdom

Royal United Hospitals Bath NHS Foundation Trust; 🇬🇧 Bath, Somerset, United Kingdom

NHS Grampian; 🇬🇧 Aberdeen, United Kingdom

Barnsley Hospital NHS Foundation Trust; 🇬🇧 Barnsley, United Kingdom

University Hospitals Dorset NHS Foundation Trust; 🇬🇧 Bournemouth, United Kingdom

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