Drug development trials are one of the final stages of research that test the safety and efficacy of new medications.
The Clinical Trials Division (CTD) team at Alzheimer’s Research Australia works with major international pharmaceutical companies to examine new potential treatments to delay and prevent the progression of Alzheimer’s disease.
The drug trials conducted at ARA have already gone through extensive safety testing. They follow strict, scientific standards which protect participants and enable the efficacy of the new treatment to be assessed.
Some trials are for people who do not have symptoms, while others are for people who have mild cognitive impairment due to Alzheimer’s disease.
The Clinical Trials Division of ARA is based at the Hollywood Specialist Centre in Nedlands, Western Australia. It is supervised by Associate Professor Dr Roger Clarnette, a senior specialist physician at Fremantle Hospital and Hollywood Private Hospital who has a particular interest in memory loss and Alzheimer’s disease.
The Clinical Trials Division at ARA is highly recognised nationally and internationally as an important facility testing new potential treatments for Alzheimer’s disease which are conducted under very strict national and international standards.
Participate in research
Some trials are for people who have no symptoms but are at risk of Alzheimer’s, while other trials are for people who have mild cognitive impairment (MCI) due to mild or moderate Alzheimer’s disease. There are many types of trials due to the testing needed for different drugs. For instance, some trials may involve taking an oral tablet daily and be three months long, while others may involve monthly visits for several years.
New drugs and therapies have to go through extensive years of testing before they are tested in clinical trials on humans.
Before they begin a trial, every participant:
- Receives comprehensive information about the study’s purpose, procedures, and potential impacts before providing written informed consent
- Is assessed by a qualified doctor who undertakes medical questions and examinations
- Completes memory and functioning assessments with qualified staff
- Gives samples for laboratory analysis such as blood and urine
- May have imaging scans such as MRI and PET performed
Expert researchers
The Team
The ARA Clinical Trial Division is managed by Paula Mather, who has an exceptional background in Alzheimer’s clinical trials. Paula manages a team of Medical Practitioners, Clinical Trial Coordinators, and Administrative staff.
With a degree in biomedical science and a qualification in genetic counselling, Paula has over 10 years of experience in this field. She has been involved in more than 50 clinical trials, focusing extensively on Alzheimer’s disease and collaborating with large international pharmaceutical companies.
Her leadership brings an attention to detail, adherence to regulatory standards, and excellence in every phase of research, with the focus always on the patient. Paula’s dedication to advancing medical knowledge in Alzheimer’s disease research, coupled with her managerial acumen, solidifies her as a highly respected figure in the field of Alzheimer’s clinical trials.
Highest standards
Is it safe?
The drug development trials conducted at the Clinical Trials Division are conducted under the ethical codes of both ARA and a human research ethics committee, following strict national and international standards. Every trial requires approval by an independent ethics committee – registered with the Australian Government’s National Health and Medical Research Council (NHMRC).
Alzheimer’s Research Australia follows regulations and guidelines in accordance with international certification under Good Clinical Practice (GCP) and in accordance with the Therapeutic Goods Administration (TGA, Australia), Food and Drug Administration (FDA, USA) and Medicines Australia guidelines.
Drug development trials
Research
Our excellence in research is at the forefront of the global fight against Alzheimer’s disease.