Open studies

To identify genetic variants that predispose to or cause Parkinson’s disease or Parkinsonism.  To identify families that may be prepared to participate in translational research related to PD, its aetiology, biology, progression and future treatment.

The registers will offer people with Parkinson’s Disease in Devon and Cornwall the opportunity to participate in future research projects. Patients will be provided with information about the register and asked to provide informed consent to keep their details on a bespoke database and to contact their doctors when necessary to clarify any clinical details and to confirm the diagnosis. Register will be kept up to date on an annual basis using a short questionnaire asking about any change in circumstances. The register will not be research itself, but form a resource whereby investigators in separate research projects with ethical approval will contact DeNDRoN management when looking for participation in such research in Parkinson’s Disease. The register will be overseen by a disease register steering committee. The register will be used to identify people who will then be contacted about possible inclusion in clinical studies.

Full title: A Randomised Placebo-Controlled Trial of Escitalopram and Nortriptyline with Standard Psychological Care for Depression in Parkinson’s Disease

Summary: Parkinson’s disease (PD) is a progressive neurological disorder that leads to increasing disability and functional decline. Currently, no medications have been shown to halt or delay disease progression. One of the most common complications in patients with this diagnosis is depression, which affects approximately 40% of patients with PD. It is linked to functional impairment, cognitive decline and faster disease progression and is the main determinant of poor quality of life in PD. Psychological therapies are used to treat depressive symptoms (via standard access to appropriate psychological services in the NHS), but often antidepressant medications are required. Despite the high incidence of depression in this population, no conclusive evidence on appropriate choice of antidepressants in PD exists in the NHS; the risk of worsening of parkinsonism and aggravation of non-motor features of PD by antidepressants pose particular challenges in this population.

The aim of the trial is to test the clinical effectiveness and cost-effectiveness of two different types of antidepressants: escitalopram ( a and nortriptyline treatment for depression in PD in addition to standard psychological care. Patients will be randomly assigned to one of the two drugs or a placebo and followed up for one year.

Full title: CHIEF-PD (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

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, it would tackle one of the most disabling complications of the disease and positive findings will provide robust evidence to change clinical practice.

Full title: Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with motor fluctuations and associated pain

Summary: Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with motor fluctuations and associated pain.

Full title: Remote assessment of Parkinsonism supporting ongoing development of interventions in Gaucher’s disease

Summary: This project aims to remotely detect the early signs and symptoms of Parkinson’s disease (PD) in a group of patients who carry a gene (glucocerebrosidase-GBA) which causes a genetic predisposition to it. We aim to detect these signs and symptoms prior to the clinically diagnostic onset of the movement related (motor) symptoms of the disease. We will assess for signs and symptoms including anxiety, depression, bradykinesia (slowness of movement), cognitive decline, reduced sense of smell, abnormal sleep behaviours, constipation and erectile dysfunction associated with the very early stages of PD.

Participants will be required to undertake a questionnaire and a number of interactive assessments, which are designed to identify risk factors and early clinical signs of Parkinson’s. Participants will be genotyped in order to establish genetic factors which determine those who do and do not develop PD.

The answers to this questionnaire/assessments/genotyping will be stored in a secure internet database and will generate a risk score. Blood, urine and cerebrospinal fluid will be analysed to look for biological markers that predict the onset of PD. Under most circumstances the study will be undertaken entirely at the participant’s home, either through an internet portal or with the use of postal assessments. We intend that this study will enable us to understand and describe the early stages of PD in this patient group and provide insights into the genetic risk factors that contribute to it.

Studies in follow up