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

University of Bristol

Status and phase: Active, not recruiting; Phase 3

Conditions: Parkinson Disease

Treatments: Other: Placebo Transdermal System; Drug: Rivastigmine Transdermal System

Study type: Interventional

Funder types: Other

Identifiers

NCT04226248

Study 2018-2030

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

600 participants in 2 patient groups, including a placebo group

Active (Rivastigmine)

Active Comparator group

Description:

Rivastigmine Transdermal Patches

Treatment:

Drug: Rivastigmine Transdermal System

Placebo

Placebo Comparator group

Description:

Placebo Matched Transdermal Patches

Treatment:

Other: Placebo Transdermal System