ANZCTR search results

In this randomised, double-blind, placebo-controlled study, 80 adults aged 50 to 85 years with mild cognitive impairment will be randomly assigned to receive capsules containing either a curcumin extract (Longvida, 400 mg daily) or a placebo for 12 weeks. Changes in cognitive performance will be assessed at baseline and week 12 by administering the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the Montreal Cognitive Assessment (MoCA). Moreover, to help understand how curcumin works to improve cognitive function, changes in blood concentrations of Brain-derived neurotrophic factor (BDNF) and Amyloid beta (Aß) will be measured over time.

The aim of this study is to investigate the impact of health information written at different grade reading levels on knowledge, perceived reading ease and acceptability. We will also explore whether there are differences in scores across health literacy and education. We hypothesize that information written at higher grade reading levels will result in lower knowledge scores, perceived reading ease and acceptability.

This study aims to assess the safety and tolerability of a new cancer treatment drug, LSTA1, in combination with durvalumab, gemcitabine and nab-paclitaxel, as first-line treatment for patients with locally advanced pancreatic ductal adenocarcinoma (PDAC). Who is it for? You may be eligible for this study if you are aged 18 years or older (or aged 20 or older if Japanese), you have been diagnosed with locally advanced pancreatic ductal adenocarcinoma and you have not yet started treatment for your cancer. You will also need to meet certain health criteria prior to being eligible for this study. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of 3 treatment groups. Participants allocated to the first treatment group will receive gemcitabine, nab-paclitaxel and two placebo treatments. Participants allocated to the second treatment group will receive gemcitabine, nab-paclitaxel, LSTA1 and one placebo treatment. Participants allocated to the third treatment group will receive gemcitabine, nab-paclitaxel, LSTA1 and durvalumab treatments. All treatments will be administered on set days of a 28-day treatment cycle. Participants will continue to receive their allocated treatments every 28 days unless they experience any serious side effects, they have disease progression or such a time that their health deteriorates to the point where the treatment is no longer practicable . During treatment, participants will be asked to undergo blood tests, imaging and a biopsy to determine how the treatment is affecting their cancer. It is hoped this research will determine whether adding the new cancer treatment drug, LSTA1 and immunotherapy to currently used cancer treatment drugs is safe and whether it has any effect on cancer cells. If this study finds that LSTA1 is safe to use in combination with the current cancer treatment drugs, it may be expanded to a larger study to further assess the effect of LSTA1 on cancer cells for patients with locally advanced pancreatic ductal adenocarcinoma. Thus far, we have not been able to get immunotherapy to engage with pancreatic cancer cells. Early studies, however, indicate that LSTA1 changes the tumour environment to make the immune cells work more effectively. This mechanism decreases immunosuppressive Tregs (Regulatory T cells (Tregs) which are a specialised subpopulation of T cells that act to suppress immune response against the tumour) and increases the percentage of cancer-fighting CD8+ T cells within the tumour. (CD8+T cells can mount a response against pathogens by secreting cytokines and can defend against tumours by directly killing transformed cells.)

Glaucoma results in irreversible visual field loss so early detection and diagnosis of this disease is needed to avoid sight loss. Pupillary light responses and analysis of saccadic movements are new techniques for the detection of glaucoma. The purpose of this study is to identify robust features of pupillary light responses and saccades as demonstrated using a commercial eye tracking device that may be used to identify and assess for abnormalities of eye gaze. The ultimate aim of this work is to develop an automated diagnostic tool for the diagnosis and assessment of abnormalities for people living in rural and remote communities. Patients will be able to record eye gaze under specified conditions. The recordings will be analysed and eye gaze recordings and their analysis sent to a specialist physician. The aim of this study is to ascertain features of eye gaze that are most useful in identifying differences between glaucoma patients and healthy age-matched controls using a commercially available eye tracker. The hypothesis is that Glaucoma patients will exhibit significantly different eye gaze responses compared with healthy age-matched controls.

Eye movement abnormalities including the pupillary light reflex (PLR) and saccades occur in movement disorders including Parkinson’s disease. The purpose of this study is to identify robust features of eye gaze as demonstrated using a commercial eye tracking device that may be used to identify and assess eye movement abnormalities in Parkinson’s disease patients and those at risk of developing Parkinson’s disease. The ultimate aim of this work is to develop an automated diagnostic tool for the diagnosis and assessment of eye gaze abnormalities for people living in rural and remote communities. Patients will be able to record their eye gaze under specified conditions. The recordings will be analysed and eye gaze and analysis sent to a specialist physician. The aim of this study is to ascertain features of the PLR and saccades that are most useful in identifying differences between Parkinson’s disease patients and healthy age-matched controls using a commercially available eye tracker. The hypothesis is that Parkinson’s disease patients will exhibit significantly different eye gaze features compared with healthy age-matched controls.

Parkinson’s disease is characterised by impaired motor function including stiffness, bradykinesia and tremor. These changes also affect hand writing causing changes in writing kinematics and pen pressure. Changes in hand writing may also be an early marker of Parkinson’s disease. Computerised graphic tablets are capable of analysing the dynamic aspects of writing. The aim of this study is to ascertain features of different hand writing tasks that are most useful in identifying differences in hand writing features between Parkinson’s disease patients and healthy age-matched controls using a computerised graphic tablet. The hypothesis is that Parkinson’s disease patients will exhibit significantly different dynamic features of hand writing compared with healthy age-matched controls.

Speech impairment is an early sign of Parkinson’s disease. Analysis of features of voice may be used as a diagnostic tool for the detection of Parkinson’s disease and in the assessment of its severity. In addition, people living in rural and remote communities often have difficulties in accessing specialist physicians for both diagnosis and continued assessment of Parkinson’s disease. The ultimate aim of this work is to develop an automated diagnostic tool for the assessment of speech impairments associated with Parkinson’s disease that may be used remotely. Patients will be able to record their voice on their personal device. Voice recordings will be analysed and the recorded voice and analysis sent to the specialist physician. The aim of this study is to ascertain features of the voice that are most useful in identifying differences in voice features between Parkinson’s disease patients and healthy age-matched controls using a mobile device. The hypothesis is that Parkinson’s disease patients will exhibit significantly different voice features compared with healthy age-matched controls.

The Endometriosis Pain Course is an internet-delivered psychological treatment that addresses the impacts of endometriosis-associated symptoms and difficulties, such as chronic pain, on women's daily functioning and wellbeing. The course is based on cognitive behaviour therapy principles and consists of 5 lessons released over an 8-week period. Each lesson covers a different topic and introduces 1-2 core CBT skills designed to promote self-management, psychological wellbeing and quality of life. In addition to the core lessons, the program includes extra resources such as redirecting attention from pain and do-it-yourself guides to promote skills practise. Alongside the internet-delivered materials, participants have the option of accessing telephone support from a Clinical Psychologist who is available during the 8 weeks to discuss concepts, answer questions and promote and encourage skills practise. This intervention will be a modified version of the Pain Course, which was developed and validated through 4 randomised controlled trials by the eCentreClinic at Macquarie University and is now widely available through the MindSpot Clinic. The aim of this study is to investigate the efficacy of a psychologically-based pain management program when specifically adapted for women with endometriosis. We hypothesise that, compared to a delayed treatment waitlist group, participants in the Endometriosis Pain Course will report greater symptom improvements (in terms of mood, anxiety and level of pain-related disability). By recruiting a large group of participants, we are also aiming to understand what particular groups of people (or what participant characteristics) may benefit most from the Endometriosis Pain Course.

This study is being conducted to investigate the efficacy and durability of faricimab (trade name: Vabysmo), given as an intravitreal injection into the eye. Faricimab is believed to improve visual function in patients currently treated for neovascular age-related macular degeneration (nAMD) with longer lasting effects. An open labelled, single-arm, multi-centered study will be conducted. Faricimab (trade name: Vabysmo) is a recently approved therapeutic agent, which acts by preventing the growth of abnormal blood vessels in the back of the eye. Faricimab is given as an injection into the eye, similar to current standard of care therapies for nAMD. Eligible patients will be switched to receive faricimab treatment given by intravitreal injection into the eye over 24 months. Following four monthly loading doses, the interval between treatments and study visits will be extended or reduced depending on if there is disease activity present. At each visit, a variety of ocular imaging procedures and assessments will be conducted to monitor the ocular health of the eye and assess visual function.

Australia is on the cusp of a potential outbreak of Japanese encephalitis (JE) viral infections as we move into spring and summer and having back-to-back La Niña seasons. There are effective JE vaccines which are licensed for children over 9 months old and given by subcutaneous (SC) injection. Intradermal (ID) vaccine administration only uses 1/5 of the subcutaneous dose and is therefore “dose sparing” enabling more people to be vaccinated from each vaccine vial. ID JE vaccination has found to be safe and immunogenic in adults, however has not yet been tested in children and adolescents. One recent study suggests that as much as 3% of the Australian population may be at risk of JE virus (JEV) exposure. In a naïve population, the risk of severe disease is likely to be equally distributed between age-groups. Of the 6 JEV deaths recorded in 2022, one was an infant. The aim of this project is to study immunogenicity and safety of JE viral vaccine (Imojev®) given ID using traditional needle and syringe in children and adults and to compare safety and immunogenicity with Imojev® given via the current recommended SC route. The results will be useful to inform vaccination programs if there is a significant JEV outbreak and especially if we have insufficient supplies of JE vaccines in Australia to vaccinate our most at risk populations, including children.