Neurodegenerative disorders (NDDs) represent an unprecedented public health burden. These disorders are clinically heterogeneous and therapeutically challenging, but advances in discovery science and trial methodology offer hope for translation to new treatments. Against this background, there is an urgent unmet need for biomarkers to aid with early and accurate diagnosis, prognosis and monitoring throughout the care pathway and in clinical trials.

Investigations routinely used in clinical care and trials are often invasive, expensive, time-consuming, subjective and ordinal. Speech data represent a potentially scalable, non-invasive, objective and quantifiable digital biomarker that can be acquired remotely and cost-efficiently using mobile devices, and analysed using state-of-the-art speech signal processing and machine learning approaches. This prospective case–control observational study of multiple NDDs aims to deliver a deeply clinically phenotyped longitudinal speech dataset to facilitate development and evaluation of speech biomarkers.

People living with dementia, motor neuron disease, multiple sclerosis and Parkinson’s disease are eligible to participate. Healthy individuals (including relatives or carers of participants with neurological disease) are also eligible to participate as controls. Participants complete a study app with standardised speech recording tasks (including reading, free speech, picture description and verbal fluency tasks) and patient-reported outcome measures of quality of life and mood (EuroQol-5 Dimension-5 Level, Patient Health Questionnaire 2) every 2 months at home or in clinic. Participants also complete disease severity scales, cognitive screening tests and provide optional samples for blood-based biomarkers at baseline and then 6-monthly. Follow-up is scheduled for up to 24 months. Initially, 30 participants will be recruited to each group. Speech recordings and contemporaneous clinical data will be used to create a dataset for development and evaluation of novel speech-based diagnosis and monitoring algorithms.

Digital App for Speech and Health Monitoring Study was approved by the South Central—Hampshire B Ethics Committee (REC ref. 24/SC/0067), NHS Lothian (R&D ref. 2024/0034) and NHS Forth Valley (R&D ref. FV1494). Results of the study will be submitted for publication in peer-reviewed journals and conferences. Data from the study will be shared with other researchers and used to facilitate speech processing challenges for neurological disorders. Regular updates will be provided on the Anne Rowling Regenerative Neurology Clinic web page and social media platforms.

ClinicalTrials.gov NCT06450418 (pre-results).

Chronic obstructive pulmonary disease (COPD) is characterised by progressive airflow limitation that is not fully reversible and is associated with an abnormal inflammatory response of lungs to noxious particles and gases. The inflammatory and reparative processes occurring in the lungs induce a ‘spill-over’ of inflammatory mediators into the circulation, resulting in an increase in systemic inflammation, which is further increased during acute exacerbations of COPD (AECOPD), leading to the development of extra-pulmonary comorbidities, such as cognitive impairment. Cognitive impairment affects up to 61% of people living with COPD. Heightened levels of inflammation have been linked to increased risk of cognitive impairments; however, the exact mechanisms remain unclear, thus hampering the development of therapeutics. This study aims to determine whether patients hospitalised with an acute COPD exacerbation show impaired cognitive function compared with recovery (~day 45), and whether such dysfunction is associated with systemic inflammation and oxidative stress.

A prospective, observational study will be conducted at Austin Health in Victoria, Australia. Eligible participants will be assessed during admission for AECOPD and following stabilisation (approximately day 45). The primary outcome is the difference in cognitive function between admission for AECOPD to recovery using non-verbal cognitive tests. Secondary outcomes are changes in systemic markers of inflammation, oxidative stress and ACE2 catalytic activity. Tertiary outcomes are anxiety and depression scores.

Ethical approval has been granted in Australia by Austin Health Human Research Ethics Committee (HREC 56099) with governance approval at Austin Hospital. The results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. Findings will be disseminated to consumers in publications for lay audiences.

Amoxicillin is recommended for children with uncomplicated severe acute malnutrition (SAM). However, some trials have shown no difference in amoxicillin for nutritional recovery in children with SAM compared with placebo. In addition, amoxicillin treatment requires two times per day dosing for 7 days, which may influence adherence. Azithromycin is a broad-spectrum antibiotic that can be provided as a single dose and has reduced mortality in children aged 1–59 months when provided by mass drug administration. The AMOUR trial is designed to assess amoxicillin, azithromycin and placebo as part of outpatient treatment of uncomplicated SAM.

This double-masked randomised controlled trial will enrol 3000 children over 3 years in an individually randomised 1:1:1 allocation to azithromycin, amoxicillin or placebo arms and follow them for 12 months. Children eligible to enrol in the study will be aged 6–59 months and have uncomplicated non-oedematous SAM as defined by weight-for-height Z-score

Ethical approval was obtained from the Institutional Review Board at the University of California, San Francisco (Protocol 23–39411) and the Comité d’Ethique pour la Recherche en Santé in Ouagadougou, Burkina Faso (Protocol 2024-01-08). The results of this study will be disseminated to the Ministry of Health, community stakeholders and via peer-reviewed publications and academic conferences.

NCT06010719.