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A Special Focus on Progress in Alzheimer’s Disease Treatment

  • Alzheimer’s disease is one of the most challenging contemporary issues in healthcare, with over 35 million people, globally, estimated to be living with the condition. This figure is projected to rise to 115 million by 2050, taking into account ageing populations around the world.1 However, recent developments in the field, including promising results from a number of international clinical trials for new treatments, provide evidence that the disease will be prevented or slowed down in far greater numbers of people in the future. With this in mind, the EMJ recently interviewed Dr Emer MacSweeney, CEO and Medical Director of Re:Cognition Health, to discuss these exciting advancements and in particular the international clinical trials, which provide an opportunity to gain early access to these new-generation medications to slow down progression of cognitive symptoms. Re:Cognition Health has been involved in several of the international studies, from which results have been reported recently.

    Parallel Developments
    Dr MacSweeney, a consultant neuroradiologist, takes a keen interest in the major advancements in new diagnostic imaging techniques for cognitive impairment disorders. In particular, identification of specific biomarkers for Alzheimer’s disease, enables detection very early, when symptoms are still mild.

    “The exciting ‘game changer’, is the simultaneous development of, firstly, new diagnostic imaging techniques for identification of early biomarkers, specific for Alzheimer’s disease, which can be detected when symptoms are very mild or even before symptoms of cognitive impairment are present,” elucidated Dr MacSweeney. “And secondly, access to new medications which when given early, slow down or, ideally, halt progression of Alzheimer’s disease and symptoms. Today, the opportunity exists for those individuals, who are clinically eligible, to gain early access to these new medications, through final phase international clinical trials designed to slow further progression of disease and symptoms, while symptoms are still very mild.”

    Abnormal Amyloid and Tau Proteins
    In particular, the biomarkers targeted for detection and new therapies are mainly linked to abnormalities in the amyloid and tau proteins. It is becoming increasingly recognised that when such irregularities occur in these proteins, the destruction of cognitive brain cells follows. Dr MacSweeney explained that the aim of the new-generation medications is to reduce the accumulation of toxic amyloid and tau proteins in the brain, thereby slowing the rate at which the cognitive brain cells are destroyed. This ultimately reduces the rate of progression from mild cognitive symptoms to Alzheimer’s disease with dementia. “If the rate at which people progress to dementia can be delayed by 5 years, it will be possible to halve the number of people suffering from dementia in their lifetime. A very significant amount of money is being ploughed into this research currently to try to find the drugs that will slow down progression of cognitive impairment,” she stated.

    Lifestyle Risk Factors
    Dr MacSweeney explained that Alzheimer’s is frequently poorly diagnosed and many people die with dementia without ever having received a specific diagnosis of the cause for their dementia. An accurate diagnosis for an individual’s cognitive symptoms is important, as there are multiple causes of loss of memory and other cognitive symptoms. Many of these causes or conditions are reversible if detected early; for example, stress, anxiety, depression, abnormal thyroid function, and low haemoglobin. Correction of reversible conditions including proactive lifestyle changes is therefore crucial. Research has demonstrated that management of lifestyle can reduce the chances of developing dementia; for example, one recent study estimated that changes to nine lifestyle factors could reduce the risk by 30%. 2

    Urgent Requirement
    The rate at which Alzheimer’s is growing around the world makes the need for breakthroughs and new strategies an urgent requirement, particularly in the context of ageing societies worldwide. If the prevalence of the disease progresses at projected rates, the costs (financial, but also social and emotional) of caring for these patients will be unsustainable. It is most certainly not a problem that is reserved for the western world either, with countries like Japan and China also experiencing extremely high rates of Alzheimer’s. According to some estimates, there will be a 125% increase in cases in the Middle East and North Africa by 2050.1

    Lack of Medications
    Exacerbating the problem is the distinct lack of new drugs that are available for patients in recent years; those that can be prescribed do not properly address the underlying disease factors. “The only medications that are available today, on the market through your doctor, are symptomatic medications for Alzheimer’s,” explained Dr MacSweeney. “These drugs enable the dying brain cells to work more efficiently to give you a symptomatic improvement. That is it boosts cognitive function, temporarily. These medications cannot slow down the death of the underlying brain cells. However, the new medications are designed to keep the dying brain cells alive.”

    Importance of Clinical Trial Participation
    The new medications described by Dr MacSweeney could therefore be a source of great relief to patients in the future, once approved by the regulatory authorities. Until this time, patients have the opportunity access these new-generation treatments by participating in clinical trials. This is an opportunity that Dr MacSweeney and the team at Re:Cognition Health are passionate about encouraging more individuals to take advantage of. Re:Cognition Health have four centres in the UK where clinical trials take place, and have also recently opened one in Washington, USA.

    Because the trials are entirely funded by the pharmaceutical industry, they are free to patients who participate. As long as the patients fulfil the eligibility criteria, specific to the study, they have the chance get early access to a new medication designed to slow down or ideally halt progression of their condition, in addition to receiving a full medical assessment. Although participants will be randomised to receive either active treatment or a placebo, usually all the participants will receive the active medication at the end of the randomised section of the study. “Currently, there are no drugs on the market, designed to slow down progression of Alzheimer’s disease and symptoms,” explained Dr MacSweeney. “Therefore, these international clinical trials provide an opportunity to change outcome.”

    “Ultimate Investment”
    From a patient’s point of view, Dr MacSweeney described participating in such trials as “the ultimate investment,” because of the major benefits that can accrue from doing so; not just, hopefully, from slowing down progression of one’s cognitive symptoms, but in helping to prevent the wider implications that Alzheimer’s can have on friends and family of the patient. “The most common thing people say to us when they find us and get into a study is: ‘I wish I’d known about this earlier’; pretty much everybody who knows about this opportunity wants to come onto a trial,” she added.

    Demographic Variation
    One of the challenges worldwide in clinical trials is to recruit a demographically diverse cohort of individuals. This is, of course, important for enabling people from all backgrounds the opportunity to get access to new treatments that can dramatically improve their health, but also for enhancing the validity of the study results. “It’s really important for the clinical trials to have people of all race, social class etc. It’s completely open, there’s no restriction and the more diverse the better,” explained Dr MacSweeney. “But, as often happens, it’s the people who have the ability seek out and find out about the studies that tend to be the people who get onto the trials, because we can only enrol those who have contacted us and are clinically eligible.” Therefore, increasing public education and awareness about clinical trials is absolutely key to increasing participation in general, and particularly from less well represented groups. The clinic does this through a variety of methods, including seminars, social media, and their call centre, as well as reaching out to general practitioners as much as they possibly can.

    Ongoing Trials
    Dr MacSweeney informed us about some exciting trials enrolling currently at the clinic. This includes one for people who are cognitively normal, but ‘silently’ carry certain biomarkers known to put the individual at increased risk of developing Alzheimer’s disease in the future. The purpose of the study is to provide these individuals identified to be at increased risk early access to new-generation medications to push out the time at which they might otherwise develop symptoms. Other studies focus on those people with mild cognitive impairment or mild or moderate dementia. “The emphasis of the new studies is for individuals with milder symptoms; it’s a bit like an escalator: the whole idea is to stop people going down the escalator; the future is early detection of disease biomarkers, ideally before symptoms even develop, plus early treatment to slow or halt further progression of memory loss and other symptoms of cognitive impairment,” she explained.

    Optimism for the Future
    Overall, Dr MacSweeney is cautiously optimistic about the prospects for Alzheimer’s disease, thanks to the positive developments in new treatments. The fact that governments and healthcare organisations are increasingly recognising the potential future scale of the issues from Alzheimer’s disease is also a reason to believe that increasing funding will go into preventing and curing the condition. We look forward to seeing more encouraging results from the ongoing trials, and ultimately, new treatments being made available to patients.

    References
    Alzheimer’s Disease International. The Global Impact of Dementia 2013–2050. 2013. Available at: https://www.alz.co.uk/research/GlobalImpactDementia2013.pdf. Last accessed: 26 January 2018

    Livingston G et al. Dementia prevention, intervention, and care. The Lancet. 2017;390(10113):2673-734.

    For more information, visit ReCognition Health

Alzheimer’s disease is one of the most challenging contemporary issues in healthcare, with over 35 million people, globally, estimated to be living with the condition. This figure is projected to rise to 115 million by 2050, taking into account ageing populations around the world.1 However, recent developments in the field, including promising results from a number of international clinical trials for new treatments, provide evidence that the disease will be prevented or slowed down in far greater numbers of people in the future. With this in mind, the EMJ recently interviewed Dr Emer MacSweeney, CEO and Medical Director of Re:Cognition Health, to discuss these exciting advancements and in particular the international clinical trials, which provide an opportunity to gain early access to these new-generation medications to slow down progression of cognitive symptoms. Re:Cognition Health has been involved in several of the international studies, from which results have been reported recently.

Parallel Developments
Dr MacSweeney, a consultant neuroradiologist, takes a keen interest in the major advancements in new diagnostic imaging techniques for cognitive impairment disorders. In particular, identification of specific biomarkers for Alzheimer’s disease, enables detection very early, when symptoms are still mild.

“The exciting ‘game changer’, is the simultaneous development of, firstly, new diagnostic imaging techniques for identification of early biomarkers, specific for Alzheimer’s disease, which can be detected when symptoms are very mild or even before symptoms of cognitive impairment are present,” elucidated Dr MacSweeney. “And secondly, access to new medications which when given early, slow down or, ideally, halt progression of Alzheimer’s disease and symptoms. Today, the opportunity exists for those individuals, who are clinically eligible, to gain early access to these new medications, through final phase international clinical trials designed to slow further progression of disease and symptoms, while symptoms are still very mild.”

Abnormal Amyloid and Tau Proteins
In particular, the biomarkers targeted for detection and new therapies are mainly linked to abnormalities in the amyloid and tau proteins. It is becoming increasingly recognised that when such irregularities occur in these proteins, the destruction of cognitive brain cells follows. Dr MacSweeney explained that the aim of the new-generation medications is to reduce the accumulation of toxic amyloid and tau proteins in the brain, thereby slowing the rate at which the cognitive brain cells are destroyed. This ultimately reduces the rate of progression from mild cognitive symptoms to Alzheimer’s disease with dementia. “If the rate at which people progress to dementia can be delayed by 5 years, it will be possible to halve the number of people suffering from dementia in their lifetime. A very significant amount of money is being ploughed into this research currently to try to find the drugs that will slow down progression of cognitive impairment,” she stated.

Lifestyle Risk Factors
Dr MacSweeney explained that Alzheimer’s is frequently poorly diagnosed and many people die with dementia without ever having received a specific diagnosis of the cause for their dementia. An accurate diagnosis for an individual’s cognitive symptoms is important, as there are multiple causes of loss of memory and other cognitive symptoms. Many of these causes or conditions are reversible if detected early; for example, stress, anxiety, depression, abnormal thyroid function, and low haemoglobin. Correction of reversible conditions including proactive lifestyle changes is therefore crucial. Research has demonstrated that management of lifestyle can reduce the chances of developing dementia; for example, one recent study estimated that changes to nine lifestyle factors could reduce the risk by 30%. 2

Urgent Requirement
The rate at which Alzheimer’s is growing around the world makes the need for breakthroughs and new strategies an urgent requirement, particularly in the context of ageing societies worldwide. If the prevalence of the disease progresses at projected rates, the costs (financial, but also social and emotional) of caring for these patients will be unsustainable. It is most certainly not a problem that is reserved for the western world either, with countries like Japan and China also experiencing extremely high rates of Alzheimer’s. According to some estimates, there will be a 125% increase in cases in the Middle East and North Africa by 2050.1

Lack of Medications
Exacerbating the problem is the distinct lack of new drugs that are available for patients in recent years; those that can be prescribed do not properly address the underlying disease factors. “The only medications that are available today, on the market through your doctor, are symptomatic medications for Alzheimer’s,” explained Dr MacSweeney. “These drugs enable the dying brain cells to work more efficiently to give you a symptomatic improvement. That is it boosts cognitive function, temporarily. These medications cannot slow down the death of the underlying brain cells. However, the new medications are designed to keep the dying brain cells alive.”

Importance of Clinical Trial Participation
The new medications described by Dr MacSweeney could therefore be a source of great relief to patients in the future, once approved by the regulatory authorities. Until this time, patients have the opportunity access these new-generation treatments by participating in clinical trials. This is an opportunity that Dr MacSweeney and the team at Re:Cognition Health are passionate about encouraging more individuals to take advantage of. Re:Cognition Health have four centres in the UK where clinical trials take place, and have also recently opened one in Washington, USA.

Because the trials are entirely funded by the pharmaceutical industry, they are free to patients who participate. As long as the patients fulfil the eligibility criteria, specific to the study, they have the chance get early access to a new medication designed to slow down or ideally halt progression of their condition, in addition to receiving a full medical assessment. Although participants will be randomised to receive either active treatment or a placebo, usually all the participants will receive the active medication at the end of the randomised section of the study. “Currently, there are no drugs on the market, designed to slow down progression of Alzheimer’s disease and symptoms,” explained Dr MacSweeney. “Therefore, these international clinical trials provide an opportunity to change outcome.”

“Ultimate Investment”
From a patient’s point of view, Dr MacSweeney described participating in such trials as “the ultimate investment,” because of the major benefits that can accrue from doing so; not just, hopefully, from slowing down progression of one’s cognitive symptoms, but in helping to prevent the wider implications that Alzheimer’s can have on friends and family of the patient. “The most common thing people say to us when they find us and get into a study is: ‘I wish I’d known about this earlier’; pretty much everybody who knows about this opportunity wants to come onto a trial,” she added.

Demographic Variation
One of the challenges worldwide in clinical trials is to recruit a demographically diverse cohort of individuals. This is, of course, important for enabling people from all backgrounds the opportunity to get access to new treatments that can dramatically improve their health, but also for enhancing the validity of the study results. “It’s really important for the clinical trials to have people of all race, social class etc. It’s completely open, there’s no restriction and the more diverse the better,” explained Dr MacSweeney. “But, as often happens, it’s the people who have the ability seek out and find out about the studies that tend to be the people who get onto the trials, because we can only enrol those who have contacted us and are clinically eligible.” Therefore, increasing public education and awareness about clinical trials is absolutely key to increasing participation in general, and particularly from less well represented groups. The clinic does this through a variety of methods, including seminars, social media, and their call centre, as well as reaching out to general practitioners as much as they possibly can.

Ongoing Trials
Dr MacSweeney informed us about some exciting trials enrolling currently at the clinic. This includes one for people who are cognitively normal, but ‘silently’ carry certain biomarkers known to put the individual at increased risk of developing Alzheimer’s disease in the future. The purpose of the study is to provide these individuals identified to be at increased risk early access to new-generation medications to push out the time at which they might otherwise develop symptoms. Other studies focus on those people with mild cognitive impairment or mild or moderate dementia. “The emphasis of the new studies is for individuals with milder symptoms; it’s a bit like an escalator: the whole idea is to stop people going down the escalator; the future is early detection of disease biomarkers, ideally before symptoms even develop, plus early treatment to slow or halt further progression of memory loss and other symptoms of cognitive impairment,” she explained.

Optimism for the Future
Overall, Dr MacSweeney is cautiously optimistic about the prospects for Alzheimer’s disease, thanks to the positive developments in new treatments. The fact that governments and healthcare organisations are increasingly recognising the potential future scale of the issues from Alzheimer’s disease is also a reason to believe that increasing funding will go into preventing and curing the condition. We look forward to seeing more encouraging results from the ongoing trials, and ultimately, new treatments being made available to patients.

References
Alzheimer’s Disease International. The Global Impact of Dementia 2013–2050. 2013. Available at: https://www.alz.co.uk/research/GlobalImpactDementia2013.pdf. Last accessed: 26 January 2018

Livingston G et al. Dementia prevention, intervention, and care. The Lancet. 2017;390(10113):2673-734.

For more information, visit ReCognition Health