The initial SAS allowance was for the 21 trial participants.
Additional SAS would be up to the TGA to decide.
I expect that the doctors working with the drug will be seeing a response in trial patients and will want to give it to non trial patients also.
I find it hard to believe that with hundreds of patients participating in the trial, 2/3 of which are taking the drug, there won't many showing readily visible signs of improvement. After all, 21 people are still taking Blarcamesine five years after they started it. A five year benefit is unheard of in Alzheimer's.
This is from TTAV, posted in January. Note that there are sixteen major treatment centers participating in the trial:
Alzheimer’s drug trial shows promise By Sandy Cheu on January 31, 2020 in Industry, Research & Clinical
Participants in an international trial investigating a drug to slow down cognitive decline in people with Alzheimer’s disease have started to show significant improvements, the principal investigator tells Australian Ageing Agenda.
The trial, which is in its third phase, aims to demonstrate that the drug Anavex 2-73 benefits people with Alzheimer’s disease (read our story here).
Participants are randomly assigned either the drug or a placebo to assess effectiveness.
While the findings are only anecdotal at this stage, improvements have been noticed among individuals involved, said principal investigator Associate Professor Stephen Macfarlane.
“We’ve certainly seen individual patients, who both seem to be getting side effects from the drugs and who have shown significant improvements,” Professor Macfarlane told AAA.
“The findings we’ve got can only be anecdotal because it’s a double-blind trial, which means at the moment, we don’t know who’s taking the actual drug and who’s taking the placebo,” said Professor Macfarlane, head of clinical services at HammondCare.
Participants getting side effects, such as dizziness, suggest improvements from the drug, he said.
“The fact that they’re getting side effects and they were expected side effects based on what we know about the drug, does suggest that the people who are showing the improvements are on the active drug,” Professor Macfarlane said.
“For individual patients who have received benefits, the impact for them has been potentially life changing, such as resuming activities they previously had given away, more interest in life, more engagement and better able to converse,” he said.
For example, trial particpant Rosie Craven had lost confidence and enjoyment in many areas of life before she joined phase three of the study.
“Rosie had enjoyed watching movies and reading but as Alzheimer’s advanced, she gave up reading and found it hard to engage with movies, and often falling asleep. Now after being on the trial, Rosie is reading again and loves watching movies and discussing them afterwards.
“She was losing the capacity to write, had been anxious about leaving home for a walk, and stopped using her phone to communicate with friends and family. Now she is once again confidently going for walks, using her phone and writing greetings on cards,” she said.
Trial still recruiting The trial, which has been running for a year, is operating across 16 sites across Perth, Adelaide, Brisbane, Melbourne and Sydney, Professor Macfarlane said.
The trial is expected to open new sites in Europe and North America in the coming months, he said.
The trial has recruited around 250 of its 450 target since it commenced, Professor Macfarlane said.
“It might not sound dramatic. Most sites for most Alzheimer’s studies will be lucky to recruit eight patients per site, so across 16 sites, to have 250 in a year is really quite remarkable,” Professor Macfarlane said.
The trial is still seeking to recruit about 225 people by the end of the year ahead of its scheduled completion in 2021, he said.
People living with very early and early stages of Alzheimer’s disease in Sydney and Melbourne and are up to the age of 85 interested in participating in the study can email alzheimerstrials@hammond.com.au
Find out more about the trial and register interest at other trial sites here.
