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

Phase 1

• Conditions: This trial will investigate the effectiveness of Rivastigmine on prevention of falls in patients with Parkinson's disease; MedDRA version: 21.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-003219-23-GB
• Lead Sponsor: niversity of Bristol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-04
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

a.Diagnosis of idiopathic Parkinson’s disease.
b.Modified Hoehn and Yahr stage 1-4 disease.
c.Have experienced a fall in the previous year.
d.Able to walk =10m without aids or assistance.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 475

Exclusion Criteria

a.Previous ChEi use in 12 months prior to enrolment.
b.Hypersensitivity to rivastigmine
c.Dementia diagnosed according to Movement Disorder Society (MDS) criteria.
d.Inability to attend or comply with treatment or follow-up scheduling.
e.Non-English-speaking patients (cognitive tests performed in English).
f.Falling =4x per day.
g.Unwillingness to use an acceptable method of contraception for the duration of the trial if they are of childbearing potential.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified