The ReSPonD Study -Rivastigmine to Stabilise gait in Parkinson’s Disease. A study looking at whether Rivastigmine, a drug that can augment mental function, can stabilise walking in people with Parkinson's disease who have fallen.

Phase 1

• Conditions: Parkinson's disease; MedDRA version: 14.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-003053-25-GB
• Lead Sponsor: Research and Enterprise Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-01
• Study Completion: 2015-09-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

a) Patients with moderate (Hoehn and Yahr stage 2-3) PD. b) History of having fallen at least once in the last year. c) Participants must be able to walk, without aids, for the length of the walking protocol (18m). d) Stable on anti-Parkinsonian medication for 2 weeks prior to enrolment. e) Able to give informed consent and willing to participate.
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 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

a) Patients with any other cause (vascular, MSA, PSP normal pressure hydrocephalus) of Parkinsonism or dementia of any aetiology. b) Patients with other neurological, visual or orthopaedic problems that significantly interfere with balance or gait. c) Previous or current treatment with a cholinesterase inhibitor or absolute contraindication to cholinesterase inhibitor therapy. d) Inability to attend or comply with treatment or follow-up scheduling. e) Non-English speaking patients, as cognitive tests will be performed in English.

Study & Design

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