More to clinical trials than meets the eye

There was much interest and media buzz around news recently that researchers at Flinders University in South Australia were developing a vaccine for dementia.

The media were very excited jumping on this news with delight producing headlines like “The first ever dementia vaccine could be trialled in humans within 3 years” and “Dementia vaccine may be just years away” while the research is certainly progressing and encouraging the headline from The Conversation is probably more accurate “Alzheimer’s breakthrough? Have we nearly cured dementia? Not just yet…”

Clinical TrialsThe reality of vaccine development and progressing to human clinical trials for any potential new drug, is far more complex.

The dementia vaccine research taking place at Flinders University is still only being trialled in animal models at this stage. It will be some 2-3 years before human trails even begin. 

When they are ready to start human clinical trials they do so in phases. Phase I human clinical trials, are usually done in healthy people first to test the vaccine or drug for safety and determine maximum dosage levels and so on.

Once Phase I is complete, and if results are satisfactory, a Phase II clinical trial may then begin.

Phase II trials are then carried out in people with the condition, pending the outcome of Phase I. Depending on the trial the number of people required for human clinical trials may vary and will depend on the individual trial, usually only about 200 people to start.

With any clinical trial, there is always inclusion and exclusion criteria that all participants need to meet, this criteria will be determined by the physicians doing the trials. That means not everyone with dementia will automatically be eligible to be on the trial, the person will need to meet all the criteria requirements to qualify. This may include age, stage of dementia, type of dementia, any other medications or underlying health conditions and so on to ensure the trial is as accurate as possible.

Information about Australian trials is publicly available on the Australian Clinical Trials website. You can check on this website to see what trials are currently taking place and when the ‘dementia vaccine’ trial is ready, it will also be put on this website.