Genomics Clinical Trials Centre

 

About

 

The Genomics Clinical Trials Centre is a facility dedicated to conducting new treatment clinical trials, situated in the centre of the Gold Coast at Mermaid Waters. 

The GCT Centre consists of a multi-disciplinary team actively involved in study design, recruitment, database creation and management, biostatistical analysis and reporting for research studies in Alzheimer’s disease, migraine, hypertension, breast, skin and prostate cancer, osteoporosis and multiple sclerosis.

At present, there are 3 concurrent studies into Alzheimer’s disease, each taking a slightly different approach to unlocking this debilitating condition. These studies are made possible by the contribution of the Gold Coast community whose seniors volunteer their time and effort toward these important trials. Details of our current and past studies are outlined below. 

We are currently recruiting for a number of studies; if you or someone you know is interested in participating in these studies please contact our clinic for more information (07 5688 7170).

 

Current Studies

The GRADUATE I Study – currently recruiting (September 2018 – 2020)

The GRADUATE study is a Phase III Placebo-controlled clinical trial investigating the efficacy and safety of an investigational medication (Gantenerumab) in patients with early (prodromal to mild) Alzheimer’s disease. This investigational medication has already had some testing in humans for safety and effectiveness and is now being tested in a larger group of people to determine if the drug reduces the level of amyloid beta in the brain.  This is important because there is evidence to suggest that plaques of amyloid beta in the brain prevent cells in the brain from functioning correctly.

Participants in the GRADUATE study are involved for 3 years not including an optional 2 year open label extension study. Over the length of the study participants receive study medication via injection and monitoring of health and Alzheimer’s disease through a series of regular assessments including blood tests, heart checks, brain imaging and questionnaires.

Participants may be able to take part in the GRADUATE if they:

  • Are 50-90 years old
  • Have mild Alzheimer’s disease or memory problems that may be the early symptoms of Alzheimer’s disease
  • Have someone who they see frequently who can be their Study Partner and can:

– Attend visits with the participant when necessary

– Be available to answer questions about the participants symptoms and any changes they may notice

– Provide accurate information about the participant is feeling

 

If you are interested in participating in this trial please contact us for more information on 07 5688 7170

 

The Tauriel Study – currently recruiting (August 2018 – March 2019)

The Tauriel study is a Phase II Placebo-controlled clinical trial. This study is looking at the safety and efficacy of an investigational medication (MTAU9937A) in patients with early (prodromal to mild) Alzheimer’s disease. This investigational medication looks to bind Tau protein in order to stop or slow tau toxicity and pathology in the brain. Intracellular Tau aggregates are a known pathological finding in Alzheimers disease patients and distribution in the brain correlates with decline in cognitive domains related to the affected brain areas.

Participants in the TAURIEL study are involved in the study for approximately 22 months not including an optional open label extension period for a further 22 months. Over the length of the study participants receive study medication via infusion and monitoring of health and Alzheimer’s disease through a series of regular assessments including blood tests, heart checks, brain imaging and questionnaires.

Participants may be able to take part in the TAURIEL study if:

  • Are 50-80 years old
  • Have mild Alzheimer’s disease or memory problems that may be the early symptoms of Alzheimer’s disease
  • Have someone who they see frequently who can be their Study Partner and can:

– Attend visits with the participant when necessary

– Be available to answer questions about the participants symptoms and any changes they may notice

– Provide accurate information about the participant is feeling

 

If you are interested in participating in this trial please contact us for more information on 07 5688 7170

 

The Engage Study – recruitment ended

The ENGAGE study is investigating whether Aducanumab has the potential to be a safe and helpful treatment that slows down disease progression in people with early Alzheimer’s disease. Aducanumab is a drug that has already had some limited testing in humans for safety and effectiveness. It is now being tested further in a larger number of people. There is a substance called amyloid beta (which is a protein) found at high levels in the brains of people with Alzheimer’s disease which is believed to be one of the key features of the progression of the disease. Aducanumab binds amyloid beta and removes existing deposits and stops new deposits from forming. The ENGAGE study will last for around 4 years in total and consists of two treatment phases – an initial 18 month treatment period which has a placebo group and an optional 2- year long term extension phase of the study.

Participants in THE ENGAGE study are:

  • 50-85 years of age
  • In good health (apart from early Alzheimer’s disease)
  • Had a study partner who, for the duration of the study, is able to provide accurate information on the participant’s cognitive and functional abilities, and attend at least nine specific clinic visits over the duration of the study.

 

 

Past Studies

The Early Study

The EARLY clinical trial researched the safety and effectiveness of an investigational medicine that may have helped to delay memory loss associated with Alzheimer’s disease. The investigational medicine developed by Janssen Research and Development was designed to prevent the production of amyloid beta fragments in the brain. Amyloid beta (which is a protein) is found at high levels in the brains of people with Alzheimer’s disease and is believed to be one of the key features of the progression of the disease.  This investigational medicine aimed to reduce the formation of these amyloid beta fragments with the goal of slowing down or preventing the cognitive and functional decline associated with Alzheimer’s disease.

This trial was discontinued by the Sponsor.

https://www.janssen.com/update-janssens-bace-inhibitor-program

 

The TOMMORROW Study (301 & 303)

The TOMMORROW study is a research study seeking to learn more about the earliest stages of Alzheimer’s disease. It seeks to understand the genetic risk factors of developing Mild Cognitive Impairment (MCI) due to Alzheimer’s disease using a genetic blood test. This study will evaluate whether a new investigational test involving two specific genes (APOE gene and the TOMM40 gene) that have been previously shown to increase the risk of developing Alzheimer’s disease, can predict a person’s risk for developing mild cognitive impairment in the next 5 years. The outcomes of this study are still pending.

A second goal was to explore whether an investigational medication will delay the first symptoms of MCI due to AD in people who are cognitively normal. This study was a global phase 3 trial that recruited more than 5,000 healthy senior participants in approximately 50 study centres worldwide. The clinical trial of this investigational medication was discontinued by the Sponsor.

https://www.takeda.com/newsroom/newsreleases/2018/takeda-tommorrow-trial/

 

The HAPPy Pilot Project 

The Headache Prevention Project (HAPPy) was a study led by the George Institute for Global Health investigated the efficacy of low-dose blood pressure lowering and Cholesterol-lowering treatments in the prevention of migraine.

The trial period for this study has been completed and results are pending.