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

Last updated: August 15, 2024
Sponsor: University of Bristol
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Rivastigmine Transdermal System

Placebo Transdermal System

Clinical Study ID

NCT04226248
Study 2018-2030
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 thetrial if they are of childbearing potential.

  • Pregnancy and/or breastfeeding

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Rivastigmine Transdermal System
Phase: 3
Study Start date:
January 02, 2020
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • Barking, Havering and Redbridge University Hospitals NHS trust

    Romford, Accepted BS8 1NU
    United Kingdom

    Site Not Available

  • Manchester University NHS Foundation Trust

    Manchester, England M13 9WL
    United Kingdom

    Site Not Available

  • Betsi Cadwaladr University Health Board

    Bangor, Gwynedd LL57 2PW
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk NR4 7UY
    United Kingdom

    Site Not Available

  • Lothian Health Board NHS

    Edinburgh, Scotland EH1 3EG
    United Kingdom

    Site Not Available

  • NHS Forth Valley

    Larbert, Scotland FK5 4WR
    United Kingdom

    Site Not Available

  • Royal United Hospitals Bath NHS Foundation Trust

    Bath, Somerset BA1 3NG
    United Kingdom

    Site Not Available

  • NHS Grampian

    Aberdeen, AB15 6RE
    United Kingdom

    Site Not Available

  • Barnsley Hospital NHS Foundation Trust

    Barnsley, S75 2EP
    United Kingdom

    Site Not Available

  • University Hospitals Dorset NHS Foundation Trust

    Bournemouth, BH23 2JX
    United Kingdom

    Site Not Available

  • Princess of Wales Hospital (Cwm Taf Morgannwg University Health Board)

    Bridgend, CF31 1RQ
    United Kingdom

    Site Not Available

  • North Bristol NHS Trust

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol, BS1 3NU
    United Kingdom

    Site Not Available

  • Pennine Acute Hospitals NHS Trust

    Bury, BL9 7TD
    United Kingdom

    Site Not Available

  • University Hospitals of Derby and Burton NHS Foundation Trust

    Derby, DE22 3NE
    United Kingdom

    Site Not Available

  • NHS Tayside

    Dundee, DD2 1UB
    United Kingdom

    Site Not Available

  • Gateshead Health NHS Foundation Trust

    Gateshead, NE9 6SX
    United Kingdom

    Site Not Available

  • Gloucestershire Hospitals NHS Foundation Trust

    Gloucester, GL1 3NN
    United Kingdom

    Site Not Available

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS2 3AX
    United Kingdom

    Site Not Available

  • University Hospitals of Leicester NHS Foundation Trust

    Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • The Walton Centre NHS Foundation Trust

    Liverpool, L9 7LJ
    United Kingdom

    Site Not Available

  • Homerton University Hospital NHS Foundation Trust

    London, E9 6SR
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust

    London, W6 8RF
    United Kingdom

    Site Not Available

  • University College London Hospitals NHS Foundation Trust

    London, WC1N 3BG
    United Kingdom

    Site Not Available

  • South Tees Hospitals NHS Foundation Trust

    Middlesbrough, TS4 3BS
    United Kingdom

    Site Not Available

  • Newcastle Hospitals NHS Foundation Trust

    Newcastle, NE7 7DN
    United Kingdom

    Site Not Available

  • Northumbria Healthcare NHS Foundation Trust

    Newcastle, NE27 0QJ
    United Kingdom

    Site Not Available

  • Aneurin Bevan University Health Board

    Newport, NP18 3XQ
    United Kingdom

    Site Not Available

  • Oxford University Hospitals

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • North West Anglia NHS Foundation Trust

    Peterborough, PE3 9GZ
    United Kingdom

    Site Not Available

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 5FP
    United Kingdom

    Site Not Available

  • Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, PR2 9HT
    United Kingdom

    Site Not Available

  • Royal Berkshire NHS Foundation Trust

    Reading, RG1 5AN
    United Kingdom

    Site Not Available

  • Salford Royal NHS Foundation Trust

    Salford, MA6 8HD
    United Kingdom

    Site Not Available

  • North Tees and Hartlepool Hospitals NHS Foundation Trust

    Stockton-on-Tees, TS19 8PE
    United Kingdom

    Site Not Available

  • Somerset NHS Foundation Trust

    Taunton, TA1 5DA
    United Kingdom

    Site Not Available

  • Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust

    Wigan, WN1 2NN
    United Kingdom

    Site Not Available

  • Betsi Cadwaladr University Health Board

    Wrexham, LL13 7YP
    United Kingdom

    Site Not Available

  • Yeovil District Hospital

    Yeovil,
    United Kingdom

    Site Not Available

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