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Completed

NCT Number: NCT04226248

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivastigmine Transdermal System

Drug

Rivastigmine Trandermal Patches applied once a day for up to 12 months

Placebo Transdermal System

Other

Placebo Trandermal Patches applied once a day for up to 12 months

Primary outcomes

  1. Fall rate

    Time frame: 12 months from the day the IMP is commenced

    Fall rate measured using monthly diaries and telephone calls prospectively

Secondary outcomes

  1. Parkinson's Disease (PD)

    Time frame: 12 months

    MDS-UPDRS total score in the practically defined 'ON' state and each individual subscale (1-4)

  2. Freezing of gait

    Time frame: 12 months

    New Freezing of Gait Questionnaire (NFOGQ)

  3. Frailty

    Time frame: 12 months

    Frailty assessed by the SHARE-FI

  4. Physical performance

    Time frame: 12 months

    Measured by the Short physical performance battery (SPPB)

  5. Freezing of Gait Assessment

    Time frame: 12 months

    Gait speed measured with Freezing of Gait (turn test)

  6. Gait Assessment

    Time frame: 12 months

    Gait speed measured with and without dual task

  7. Cognition

    Time frame: 12 months

    Montreal Cognitive Assessment (MoCA)

  8. Depression

    Time frame: 12 months

    Geriatric Depression Scale (GDS)

  9. Fear of falling

    Time frame: 12 months

    Iconographical Fall Efficacy Scale (ICON-FES)

  10. Dysphagia

    Time frame: 12 months

    Swallowing Disturbance Questionnaire (SDQ)

  11. Participant health related quality of life

    Time frame: 0,1,3,6 9 and 12 months

    EuroQoL 5D-5L health status questionnaire (EQ-5D-5L)

  12. Capability of older people

    Time frame: 12 months

    ICEpop CAPability measure for Older people (ICECAP-O)

  13. Mortality (all cause and PD-related)

    Time frame: 12 months

    Office of National Statistics (ONS) data

  14. Cost effectiveness by NHS resource use

    Time frame: 12 months

    NHS Hospital Episode Statistics (HES) data

  15. Apathy

    Time frame: 12 months

    Starkstein Apathy Scale

Sponsors and collaborators

Lead sponsor

University of Bristol

Other

Collaborators

  • Royal United Hospitals Bath NHS Foundation Trust

Registry information

Official study 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.

Acronym: CHIEF-PD

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jan 13, 2020
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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