Professor Perminder Sachdev
Perminder Sachdev 教授
So, the Maintain Your Brain trial is funded by the National Institute of Dementia Research, which is run by the NHMRC, the National Health and Medical Research Council of Australia. It's a $6.5 million study, grant over five years. What has happened as a result of the FINGER trial, is there are a number of kind of ‘children of FINGER’ so to speak, there are multiple FINGER trials that are happening around the world. Similar kinds of multipronged strategy to see whether you can fix everything and reduce your rate of dementia.
Now what we wanted to do was see whether we could do this at a larger scale, at a population level. The problem with a study like that, is that if you do it at an individual level, bring everyone in, assess them, it's hugely expensive. You can actually - you will spend several million dollars just to do a few hundred people or a thousand people or so. But we thought can you upscale this to a large population level, within a reasonable budget, and that’s what we are trying to with this, in the Maintain your Brain trial. We thought okay, can we do this through the web and increasingly older people are connected to the web.
Also, we don’t want to work necessarily with very old people, we want to work with people who are middle aged or getting in to that increased risk category. Because we want to work with people who have not yet developed cognitive problems, and middle age is probably the best time to catch them. In this trial, we said okay let's have a population of several thousand, in the age range of 55 to 75. We are recruiting them in New South Wales because there is already a study, a survey that’s happening, which is called the 45 and Up Study, which has a quarter of a million people enrolled in that study. They have already collected some health data over several waves in this population. So we know a little bit about their risk factors.
We’re going to actually recruit them by email and then get them to sign up for the study, and all assessments will be done on the web. So, their detailed medical information will be obtained online, and they do cognitive testing online as well. There are cognitive batteries available that can be done online. Then they do three or four modules, and we have been developing these modules to deliver physical exercise, complex cognitive activity, diet and nutrition, and stress and depression management on the web. These are 12-week courses that we developed and there is some evidence that this can be done. Of course, we have some personalised interactions, so there are virtual coaches, there are some cut offs that we use for alerting feedback, we send messages, text messages, put them in to virtual groups to try to engage them. All those activities have been built in to the platform.
They will have these three or four modules administered in the first year and then they'll have boosters happening every quarter, for each of those modules as they go forward. We assess them every year and we have funding for five years, so we’re hoping to at least have four years of assessment, to see whether we have reduced their rate of cognitive decline. We have enough numbers to see whether we actually cut down the incidence of dementia as well in this group. We have a control group, so they’re randomised via an active participant group and a control group, and the control group also logs in and they do some activities online, but usually they watch videos for example about health, about general, National Geographic videos, those kind of videos, which we previously used in control studies of this kind.
We were funded in 2016 and in fact mid 2016 is when we started developing the platform. Later part of 2017, we did some of the pilot work and from that we've gone back and modified some of the modules, and now we are going through the pilot phase of running all the modules in a subgroup of people, to see what kind of difficulties we might get. If that runs smoothly, then of course we are hoping to start the trial in 2018.
There has not been an online trial which actually has - which is multimodal of this kind really. There have been a lot of online trials now, which have looked at one or other aspect of say, for example, with physical exercise there have been some online trials, there have been online trails for cognitive activity, for nutrition there have been online trials, certainly for depression and stress management there have been many trials. But trying to put them all together, I don’t think there has been any trial like that, and certainly this will be one of the largest. The other aspect is I think the testing, we are doing online testing and we’re not doing face to face assessments in any of these people. Most other trials have done face to face assessments at baseline and follow up. They've been short trials really, not of this duration. So, this is a very ambitious trial in that sense, to see whether this can be delivered at a population level, at a large scale level, remotely and at low cost.
I think there are a number of concerns that we do have. The first concern of course is that there are many older people who are not online, and that can be about a third perhaps of very old people who are not online. Although that number is shrinking gradually, but still there are many people. Then there are other people who are online but they're very limited in their connectivity, in how comfortable they are with online activities, so they will need some extra help, some instruction. The third thing is that engaging people online, because interpersonal engagement, that face to face engagement is a different thing to engagement online. Certainly, younger people are easy to engage online, they've grown up with technology. But older people are somewhat more difficult, because they relate better to a person rather than to a virtual person in a way. That’s something that I think still we are working through and there’s not enough data, to convincingly show that yes, it’s as good as having a person there.
Previously in many of our trials, we have actually brought people in, for example for physical exercise. In the last trial we did, we brought them in to a gym and there was a gym instructor who worked with a group. That seems to work quite well, but it’s very expensive and it’s time consuming for everybody. Those are the concerns and there is some evidence that yes, you may be able to engage people initially, but then there’ll be a big drop out, and we don’t know how big that drop out is going to be over the course of the trial, which is running for several years.
I think once we have a platform, that it can be scaled up to a population level, to the whole population really. Because finally I think the ultimate objective would be that everybody at risk - and all of us are at risk of dementia. As we know by the time we reach our 90s, one in three people will have dementia and by the time - if you reach the age of 100, you have more than 50% chance of having dementia, so all of us are at risk for dementia. In fact, these risk factors apply to some degree to all of us in a way, so everyone should be doing what we are doing in this trial. But how we reach everybody in the population is the challenge, and if we have a platform like that, the objective would be to reach the whole population. It could be scaled up quite easily if it works. So, let’s hope the trial runs smoothly and that we’re able to recruit the number of people that we want to.