A new framework has been established by leading scientists and patient organisations for using two tests to improve clinical trials for identifying Parkinson’s disease (PD).
Affecting around 145,000 people in the UK, PD is a progressive neurological condition that affects the brain, causing symptoms such as shaking and stiffness.
The new staging framework, published in The Lancet, proposes how two important medical tests could be used in clinical trials of new treatments for Parkinson’s, as well as other related conditions, and have been selected for their ability to identify key biological features of the disease.
The framework involved experts from the Center for Drug Evaluation and Research, the Michael J Fox Foundation for Parkinson’s Research, Swiss pharmaceutical company Roche, Parkinson’s UK and Cure Parkinson’s.
A major challenge faced within clinical trials for PD is that most diagnoses are based on symptoms, which can differ from person to person.
By having tests that can identify what exactly is occurring inside the brain, clinical trials for PD will be more able to select the right participants and will be better able to measure the potential of the treatment under investigation.
The first test selected can identify misfolded alpha-synuclein, a protein that is a hallmark of PD, from fluid taken from the spine via a lumbar puncture test.
The second test is a brain scan known as DaTSCAN, which can identify whether there is a lack of dopamine, a chemical that progressively decreases over time in PD, within the brain.
Both tests identify people who are in the early stages of the disease before obvious symptoms emerge.
Ultimately, this will speed up the development of therapies that can stop the loss of brain cells in the disease, which, at present, no treatments have achieved.
Helen Matthews, chief executive officer at Cure Parkinson’s, commented: “Adding precision to our clinical trials is vital” and “would be a big step forward… to gain clearer answers evaluated on biology rather than clinical assessments”.