UNS-V101-PD-OBS
Research type
Research Study
Full title
Biomarker Battery and Trial Ready Cohort Development for UB-312 Anti-Alpha-Synuclein Active Immunotherapy in Parkinson’s Disease
IRAS ID
249502
Contact name
Suzanne Ostrander
Contact email
Sponsor organisation
United Neuroscience Ltd.
Duration of Study in the UK
1 years, 0 months, 10 days
Research summary
Parkinson’s disease (PD) is a chronic and progressive neurological condition that causes a variety of symptoms such as slowness of movement, stiffness and shaking. It involves the malfunction and death of vital nerve cells in the brain. Some of these dying nerve cells produce a chemical called dopamine, which sends messages to the part of the brain that controls movement. The exact causes behind the progressive loss of nerve cells are still unknown. We know, however, that a protein called α-synuclein is accumulated in the brains of people with PD and Parkinsonism and has a toxic effect on the neurons. At present, the role of other proteins in PD patients’ brains is not clear. There is a need to develop and use other tests to better understand the progression of PD, its clinical symptoms, and how different proteins and other substances in your blood may affect the disease.
United Neuroscience (UNS) is developing a novel vaccine targeting aggregated forms of α-synuclein for the treatment and prevention of PD. However, at the moment, it is not possible to monitor α-synuclein in the brain of the patients with PD.
There is therefore a need to develop and use other markers for demonstrating the effect of this vaccine on progression of PD. A battery of markers have been suggested and involve imaging, electrophysiological, and functional tests, which link α-synuclein with brain damage and development of clinical symptoms of PD.
Thus, prior to Phase 1 of the program, in which the vaccine will be tested in people with PD, we will perform an observational study aiming to use a comprehensive marker battery for trial-readiness and to assemble a homogeneous cohort of trial ready patients. Use of this biomarker battery will enable decision-making throughout the program by assisting in the inferring of target engagement, safety, proof of biology and proof of clinical concept.
REC name
London - Bromley Research Ethics Committee
REC reference
18/LO/1692
Date of REC Opinion
30 Nov 2018
REC opinion
Further Information Favourable Opinion