Dementia is a condition that results in progressive memory or thinking problems. It’s now the most common cause of death in Australia. There are many different causes of dementia, but Alzheimer’s disease accounts for around 60–80% of all cases.

Last week, Australia’s Therapeutic Goods Administration (TGA) approved a new drug for early Alzheimer’s diseases: lecanemab, sold under the brand name Leqembi. It follows the approval of a similar drug, donanemab, earlier this year.

But while lecanemab has been shown to slow the progression of disease in some people who receive an early diagnosis, it comes with a high price-tag that will put it out of reach for many Australians.

How does it work?

Lecanemab is from a class of drugs known as monoclonal antibodies.

When our bodies are confronted with foreign “invaders”, most commonly bacteria or viruses, our immune system responds by producing antibodies. These are proteins that bind to the invader and mark it out to other immune cells for destruction.

A monoclonal antibody is produced in a lab to bind to a specific target: in this case, the amyloid protein that is the microscopic hallmark of Alzheimer’s.

Once the immune system captures the antibody, it can then remove amyloid from our brains in order to limit ongoing damage.

How effective is it?

The local approval comes as a result of a large clinical trial of 1,734 participants over 18 months, which was funded by the drug company Eisai.

The trial showed a significant slowing of disease progression in a large group of patients who had either early Alzheimer’s or mild cognitive impairment due to early changes of Alzheimer’s in the brain.

Before the trial, all patients had positron emission tomography (PET) scans showing the presence of amyloid protein in their brain.

Those who received the active drug during the study progressed 27% less compared to those who were given placebo over the 18 months. This was measured by a scale of both cognition and function, known as the Clinical Dementia Rating Sum of Boxes.

Over the 18-month study period, this equates to about five months’ less decline in the group who received lecanemab.

For patients who have continued treatment, evidence of continued benefit for as long as four years has recently been presented.

Participants who received lecanemab also showed large reductions in the levels of amyloid in the brain, as measured by a PET scan. By the end of the trial, the majority of participants were considered to be below the threshold that would normally indicate the presence of Alzheimer’s, but it did not reverse their symptoms.

What are the side effects?

Regulators have raised concerns about safety. The TGA previously rejected the drug’s approval on the basis of its risk and benefit profile when it originally considered the application in October last year.

Some 12.6% of trial participants receiving the drug experienced brain swelling. The rates rose to 32.6% in those possessing two copies of an Alzheimer’s-promoting gene, apolipoprotein E4 (ApoE4).

Of those who experienced brain swelling, 22% had side effects such as headaches, dizziness, blurred vision and balance problems. These were generally mild, but a small number of participants who were also prescribed blood-thinning medications during the study had serious brain bleeds that resulted in death. The remaining 78% of those who developed brain swelling experiencing no symptoms from this.

Due to the risk of brain swelling, those taking the drug require three-monthly MRI scans to monitor their brain.

Some 17.3% of those on active drug also experienced small bleeds into the brain (microhaemorrhages), compared to 9.0% of those taking placebo.

Last year’s TGA rejection of lecanemab was appealed, and new safety and outcome data out to four years of treatment were presented as part of the appeal process.

How much does it cost?

Australia’s Pharmaceutical Benefits Scheme (PBS) does not currently subsidise lecanemab. It costs the equivalent of A$40,000 per year, placing it beyond the reach of many who might benefit from it.

Guidelines recommend dosing at fortnightly intervals for an 18-month period, with monthly “maintenance” dosing thereafter.

There are also costs associated with the monitoring required to ensure the safety and efficacy of the drug (doctors’ visits, MRI and PET scans).

The Pharmaceutical Benefits Advisory Committee (PBAC) has not yet considered lecanemab for PBS listing.

However, PBAC rejected an application for a similar drug, donanameb, for PBS listing in July, citing concerns that the benefits were “too small and uncertain to justify the burden of this treatment on both patients and the health system”.

Lecanemab works in a similar way to donanemab, which received TGA approval earlier this year. Both drugs have similar costs, efficacy and risks.

Bottom line

Lecanemab can only be used in the early stages of Alzheimer’s. If you or a loved one are experiencing early signs of Alzheimer’s diseases, such as consistent short-term memory loss or confusion about days and dates, it’s important to seek medical advice early, to obtain an accurate diagnosis and to clarify your treatment options.

If you’re considering lecanemab or donanemab, it’s important to know these drugs are not cures for Alzheimer’s disease. They may slow the progression, but they don’t improve the symptoms.

Lecanemab won’t benefit those whose dementia is caused by conditions other than Alzheimer’s, nor will it benefit those with Alzheimer’s whose disease has progressed beyond its earliest stages.

Steve Macfarlane, Head of Clinical Services, Dementia Support Australia, & Associate Professor of Psychiatry, Monash University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

We already know excessive smartphone use affects people’s mental health and their relationships.

But when new parents use digital technologies during care giving, they might also compromise their baby’s development.

Smartphone use in the presence of infants is associated with a range of negative developmental outcomes, including threats to the formation of a secure attachment.

The transition into parenthood is an ideal time for healthy behaviour change. Expectant parents see a range of professionals, but as we found in our new study, they don’t receive any co-ordinated support or advice on managing digital devices in babies’ presence.

One of the new mums we interviewed said:

Literally nothing has come up around […] screen time, or especially breastfeeding and things like that […] it’s interesting because it’s such a big part of our lives.

Another participant said:

I haven’t had anyone talk to me about tech use, at all.

Adult smartphone use is not mentioned in well-child checks. We argue this is a missed public health opportunity.

Secure attachment is important for a baby’s development. They need hours of gazing at their families’ faces to optimally wire their brains. This is more likely when the parent is sensitive to a baby’s cues and emotionally available.

But ubiquitous smartphone use by caregivers has the potential to disrupt attachment by interrupting this sensitivity and availability.

Babies’ central nervous system and senses are immature. But they are born into a rapidly moving world, filled with voices and faces from digital sources. This places a burden on caregivers to act as a human filter between a newborn’s neurobiology and digital distractions.

Disrupting relationships

Psychologists have described the phenomenon of frequent disruptions and distractions during parenting – and the disconnection of the in-person relationship – as “technoference”.

A caregiver’s eyes are no longer on the infant but on the device. Their attention is gone, in a state described as “absent presence”, and the phone becomes a “social pollution”.

It’s unpleasant for anyone on the other side of this imbalance. But for babies, whose connection to their significant adults is the only thing that can make them feel safe enough to learn and grow optimally, it causes disproportionate harm because of their vulnerable developmental stage.

During the rapid phase of brain growth in infancy, babies are wired to seek messages of safety from their caregiver’s face. Smartphone use blanks caregivers’ facial expressions in ways that cause physiological stress to babies.

When a caregiver uses their phone while feeding an infant, babies are more likely to be overfed. The number of audible notifications on a parent’s device relates to a child’s language development, with more alerts associated with fewer words at 18 months.

If that’s not reason enough to reign in phone use, evidence also shows that smartphone use can be a source of stress and guilt for parents. This suggests parents themselves would benefit from more purposeful and reduced smartphone habits.

Some public health researchers are urging healthcare workers to consider the parent-infant relationship in addition to the respective health of the baby and caregiver themselves.

This relational space between people is suffering as a result of the social pollution of smartphone-distracted care. Babies’ brains grow so fast, we mustn’t let this process be compromised by the distraction of the attention economy.

Our research shows new parents could use information and support around the use of digital devices. We also recommend that other family members modify their smartphone habits around a new baby. Whānau can create a family media plan and make sure they have someone to talk to about this issue.

Health policies should focus on early investment in parents and children, by prioritising education and action on smartphone use around babies. This would benefit the wellbeing of new parents and the lifelong development of infants.

Miriam McCaleb, Fellow in Public Health, University of Canterbury

This article is republished from The Conversation under a Creative Commons license. Read the original article.