Next stage of national drug trial underway
By Sandy Cheu on July 13, 2018 in Industry, Research & Clinical
Dementia specialist aged care provider HammondCare is leading the Australian component of an international trial testing a drug that aims to slow down cognitive decline in people with Alzheimer’s disease.
The trial is recruiting 450 people aged 60-85 living with mild cognitive impairment or mild Alzheimer’s disease across 12 sites nationally and will run for a minimum of 12 months.
It aims to demonstrate that the drug Anavex 2-73 shows benefits and improvements to those living with Alzheimer’s disease and to bring the drug to the market in the future.
The drug is a disease-modifying therapy and this trial follows promising results in an earlier Australian study, which achieved significant cognitive improvement in some participants.
This trial will test whether the drug can stabilise the progression of the disease, said Associate Professor Stephen Macfarlane, head of clinical services at HammondCare and principal investigator of the trial.
Professor Stephen Macfarlane
“It’s also important if we can slow the rate of cognitive decline to a meaningful degree,” Associate Professor Macfarlane told Australian Ageing Agenda.
“Improvement is asking a lot from a brain that is significantly damaged by the time people first develop symptoms,” Professor Macfarlane said.
While the causes of Alzheimer’s disease are unknown, damage to the brain from a build-up of toxin proteins is a theory, Professor Macfarlane said.
“We really need a drug that can impact on the course of the disease, not only to save lives but also save on future aged care costs,” Professor Macfarlane said.
“If the trial itself is successful and we come across a drug that modifies the course of the disease, it would be a complete game changer as far as aged care requirements go,” he said.
The trials are being run by American biopharmaceutical company Anavex Life Services and involved laboratory and animal testing in the first phase.
In Australia, the second phase of the trial, which commenced in 2015, involved 32 people with mild Alzheimer’s disease over a 12-month period across five sites in Melbourne.
A company sponsoring the new trial is working to determine the characteristics that differentiated participants who responded well to the drug compared to those who responded less well through genetic analysis and dosage amounts, Professor Macfarlane said.
“The new trial is designed to leverage those learnings from the earlier study and try to maximise the chances for success,” he said.
For many participants of the previous trial, their results at 12 months showed their cognitive status remained largely unchanged, he said.
Professor Macfarlane said some participants also regained functions previously lost, such as the ability to paint and play the piano while a person who re-sat the driving exam successfully regained their licence.
At the end of the study, participants requested an extension to continue to have access to the drug, which was granted.
In addition to this trial, Anavex received approval to earlier this week to also commence trialling the drug with people living with Parkinson’s disease and dementia. https://www.australianageingagenda.com.au/2018/07/13/next-stage-of-national-drug-trial-underway/
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