Oxford Study of Quantification in Parkinsonism (OxQUIP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04139551|
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : October 25, 2019
The OxQUIP (Oxford QUantification In Parkinsonism) study is recruiting patients with Parkinson's Disease and Progressive Supranuclear Palsy. Currently available treatments for these diseases are symptomatic only, and do not have any preventive or disease-slowing effect. As new drugs are developed, there is a need to be able to evaluate them quickly, so that precious time and resources can be devoted to those showing most promise.
This study follows participants intensively over an initially 3 year period, with the aim of identifying measures that can detect disease progression over much shorter time periods than is possible at present.
During the study participants are asked to perform simple tasks while the investigators measure movements of the eyes, hands and body. The investigators also do some tasks on a tablet computer that measure cognitive performance.
|Condition or disease|
|Parkinson Disease Progressive Supranuclear Palsy|
Parkinson's disease (PD) is a common neurodegenerative disease that affects one in every hundred people over the age of 55. It is estimated that there are seven to ten million people with PD worldwide. It is disabling, incurable and gradually progressive. Progressive Supranuclear Palsy (PSP) is a related condition that presents initially with very similar features to PD. Eventually other features appear that are not part of idiopathic PD, such as paralysis of voluntary upgaze. Currently available treatments for both PD and PSP are symptomatic only, and while they may be effective for a number of years, they do not have any preventive or disease-slowing effect.
One of the problems with these conditions is that presently, there is a lack of completely reliable means of measuring their severity. The investigators use "clinical rating scales" which are points-based systems in which a doctor or nurse has to score how badly the person with PD or PSP is affected by various aspects of their condition. This is a subjective process, in other words it depends on the impression of the person making the assessment, and two doctors may sometimes disagree about the score. The scale is also sometimes difficult to interpret, for example the difference between scores of 20 and 30 may not be the same size as the difference between scores of 30 and 40. In contrast, most medical conditions nowadays can be very accurately and reliably measured using special equipment, for example the level of a patient's blood pressure, or the difficulty of breathing in asthma.
The need for accurate measures is particularly great when conducting trials of new drugs. Accurate evaluation of whether they work or not depends on precise measures of disease symptoms for each patient both before and after treatment. Drug trials may take years, and an accurate early measure of effect would allow interim results to guide decisions at which point resources can be focussed on those drugs that look most promising.
The aim of this study is to develop and validate sensitive tests to measure the symptoms of PD and PSP.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Oxford Study of Quantification in Parkinsonism Study - OXQUIP|
|Actual Study Start Date :||October 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||April 2022|
OQ - 01- 1XXX Denono PD
Newly diagnosed unmedicated PD patients
OQ-01- 2XXX Mild /Moderate PD
Early to moderate stage PD patients well controlled on medication(typically fewer than 8 years since diagnosis)
OQ-01- 3XXX Advanced PD
Advanced PD patients (typically greater than 8 years duration)
OQ-01- 4XXX DBS patients
PD patients with deep brain stimulation systems
OQ-01- 5XXX PSP patients
OQ-01- 6XXX Healthy Controls
Age-frequency matched healthy controls
- Saccadic eye movements [ Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months. ]Automated measurements of rapid conjugate eye movements using a device called a saccadometer.
- Hand tapping [ Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months ]Measurement of rate of hand tapping movements made by participant on an electronic pad.
- Reaction times using a button box [ Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months ]Measurement of response time when participant is required to press a button when a light is illuminated.
- Gait measurement [ Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months ]Characterisation of gait abnormalities using a body-worn array of inertial measurement units
- Mini Mental State Examination (MMSE) cognitive tablet [ Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months ]This is a standard clinical test for cognitive impairment
- Montreal Cognitive Assessment (MOCA) [ Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months ]This is a standard clinical test for cognitive impairment
- Verbal fluency test measurement [ Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months ]Measures a participant's ability to produce a list of words according to set criteria e.g. words starting with a specific letter of the alphabet.
- Executive function testing (Oxford Cognitive Screen) [ Time Frame: 3 months, 6 months, 12 months, 18 months, 21 months, 24 months, 27 months and 30 months ]This is an electronic tablet-based battery of tasks intended to screen for deficits in executive function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139551
|Contact: Chrystalina A Antoniades, PhD||44 -1865 firstname.lastname@example.org|
|Contact: James J FitzGerald, PhDemail@example.com|
|John Radcliffe Hospital||Recruiting|
|Headington, Please Select, United Kingdom, OX3 9DU|
|Contact: Chrystalina Antoniades 07854838331 Chrystalina.firstname.lastname@example.org|
|Principal Investigator:||Chrystalina A Antoniades||University of Oxford|