Exploratory case-controlled longitudinal biomarker study on Alzheimer
Research type
Research Study
Full title
Exploratory Case-Controlled, Longitudinal Biomarker Study in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia and Untreated Matched Controls
IRAS ID
189306
Contact name
Richard Perry
Contact email
Sponsor organisation
TauRx Therapeutics Ltd.
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
According to the Alzheimer’s research UK, Alzheimer’s is the most common cause of dementia affecting around 500,000 people in the UK. Alzheimer’s Disease (AD) is a severe irreversible neurodegenerative disease resulting in complete loss of mental faculties. Early diagnosis is crucial to the patient’s treatment. At present, the only peripheral markers of AD with diagnostic and prognostic potential are measurements of total tau protein, phosphorylated tau protein and Aβ1-42 in CSF. Although these markers have shown utility in numerous studies, they are as yet unproven and suffer from the need to obtain lumbar punctures. Therefore, there remains a need for biomarkers not only to aid in identifying patients early in the course of disease, but also as a potential early marker of treatment response.
This is an exploratory, case-controlled, longitudinal study, which aims to evaluate EEG networks, potential peripheral biomarkers, psychometric markers and cognitive abilities in subjects with Alzheimer’s Disease (AD) or Behavioural Variant Front temporal Dementia (bvFTD) compared to healthy paired controls.
AD and bvFTD patients will be recruited from the pool of participants already taking part in the TauRx-sponsored Phase 3 studies: TRx-237-005, TRx-237-007 or TRx-237-015. Healthy volunteers will be recruited from the patients’ caregivers’ pool of participants and will be match on age, sex and race.
This study will last for 30 months, aims to recruit a total of 540 participants and is a global multi-center study taking place in USA, Canada and UK.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
15/WM/0337
Date of REC Opinion
13 Nov 2015
REC opinion
Further Information Favourable Opinion