Research bites

30 September 2024

Payer Coverage Considerations for Alzheimer Disease Blood-Based Biomarker Tests

Alzheimer’s Disease Biomarkers

The importance of timely, early, and accurate Alzheimer disease (AD) diagnosis is growing with the approval of new disease-modifying therapies.

As noted in recent, widely disseminated publications, advancements in blood-based biomarker tests (BBMTs) for AD offer promise in addressing the need for broadly
available, accurate diagnostic tools. 1 However, discussion about the costs of these tests and their coverage by insurers is lacking.

Currently, no BBMTs are covered by public or private insurers, leaving patients to pay high out-of-pocket
costs (eg, $1450, the list price for one marketed BBMT). If BBMTs are shown to have clinical utility, payer coverage will be crucial in ensuring equitable access and improving disparities in AD diagnosis and care.

1 September 2024

American football head impacts tied to increased brain damage and cognitive decline

In a study published in JAMA Network Open, researchers investigate how repetitive head impacts (RHI) alter perivascular space (PVS) volume, cognition, and related neurodegeneration among former American football players.

RHI and the perivascular system.

Exposure to RHI in contact sports increases the risk of developing dementia as tau protein accumulates in the brain. Nevertheless, the specific pathophysiological pathways contributing to neurodegeneration remain unclear; therefore, further research is needed to elucidate how protein concentrations in the brain change following RHI.

30 August 2024

New finger-prick blood test could revolutionize Alzheimer’s screening

‘GPs could soon be able to screen their patients for Alzheimer’s Disease (AD) using a simple handheld device developed by Monash engineers.

Monash engineers have developed the first-of-a-kind finger-prick blood test with ‘needle-in-a hay-stack’ precision to detect the hallmark (protein) biomarkers in early AD before symptoms progress.

The size of a credit card, it uses world-first patented sensor technology which can detect ultra low concentrations of disease markers in blood in minutes.

With the number of Australians diagnosed with dementia set to double by 2054, the quick blood test could become a vital tool to streamline diagnoses by giving GPs unprecedented access to non-invasive diagnostics.

Associate Professor Sudha Mokkapati from Monash Materials Science and Engineering, developed the proof-of-concept electronic sensor for point-of-care testing, removing the need for laboratory-based pathology tests, and making the process to diagnosis faster and more cost-effective.’

17 August 2024

Mapping the evidence on dementia care pathways – A scoping review

 ‘Background

One way of standardizing practice and improving patient safety is by introducing clinical care pathways; however, such pathways are typically geared towards assisting clinicians and healthcare organizations with evidence-based practice. Many dementia care pathways exist with no agreed-upon version of a care pathway and with little data on experiences about their use or outcomes.

The objectives of the review were: (1) to identify the dementia care pathway’s purpose, methods used to deploy the pathway, and expected user types; (2) to identify the care pathway’s core components, expected outcomes, and implications for persons with dementia and their care partners; and (3) determine the extent of involvement by persons with dementia and/or their care partners in developing, implementing, and evaluating the care pathways.

Methods

We systematically searched six literature databases for published literature in the English language in September 2023 utilizing Arskey and O’Malley’s scoping review framework.

Results

The findings from the dementia care pathways (n = 13) demonstrated assistance in dementia diagnostic and management practices for clinicians and offered structured care processes in clinical settings. For this reason, these pathways emphasized assessment and interventional post-diagnostic support, with less emphasis on community-based integrated dementia care.

Conclusion

Future dementia care pathway development can seek the involvement of persons with dementia and care partners in designing, implementing and evaluating such pathways, ensuring that outcome measures properly reflect the impact on persons with lived dementia experience and their care partners.’

12 August 2024

Dementia Subtypes Have Unique, Symptom-Based Functional Connectivity Alterations

Original study: Dementia Subtypes Defined Through Neuropsychiatric Symptom–Associated Brain Connectivity Patterns

‘Study authors concluded, “This cross-sectional study offers important insights into dementia heterogeneity using a data-driven analytical framework. We identified behavioural and anxiety subsyndromes capturing distinctions shared between brain circuits and [neuropsychiatric symptoms] in dementia.”’
Dementia subtypes can be distinguished by unique brain connectivity patterns and neuropsychiatric symptom severity, according to study results published in JAMA Network Open.

Although dementia is highly heterogeneous, the majority of studies assessing brain connectivity in dementia have compared cases and controls without stratifying dementia patients based on neuropsychiatric symptoms.

Tau-Targeting Immunotherapy Fast Tracked for Early Alzheimer Disease

‘In a phase 1b/2a clinical trial showed immunization with ACI-35.030 elicited antibodies against extracellular ptau in 100% of participants with early Alzheimer disease.

…

The designation was supported by data from a phase 1b/2a clinical trial (ClinicalTrials.gov Identifier: NCT04445831) that showed immunization with ACI-35.030 elicited antibodies against extracellular phosphorylated tau, a pathological form of tau, in 100% of participants with early Alzheimer disease. Findings also showed the treatment spared normal endogenous forms of the protein.

The investigational anti-phosphorylated tau active immunotherapy is currently being evaluated as a potential treatment to prevent or reduce cognitive decline in patients with preclinical Alzheimer disease in the phase 2b ReTain trial. The double-blind, placebo-controlled study is expected to enroll 500 participants (cognitively normal, tau positive). Patients will be randomly assigned to receive ACI-35.030 or placebo intramuscularly for a maximum of 4 years.’

News release: AC Immune’s ACI-35.030 (now “JNJ-2056”) Granted FDA Fast Track Designation for Alzheimer’s Disease

22 July 2024

More Depressive Symptoms in Young Adulthood May Lead to Poorer Midlife Cognition

‘Prolonged depressive symptoms during young adulthood may lead to worse cognitive function later in life, especially among Black adults, according to study findings published in Neurology.

Using prospective data from participants in the Coronary Artery Risk Development in Young Adults (CARDIA) Study, a multicenter longitudinal study involving adults aged between 18 and 30, researchers aimed to explore the relationship between trajectories of depressive symptoms over 20 years and cognition in middle-age among Black and White adults.’

3 July 2024

A new drug has been approved in the US for treatment of MCI and early Alzheimer’s disease

FDA Approves Eli Lilly’s Donanemab for Early Symptomatic Alzheimer Disease

“Less than a month following a positive recommendation from the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, the agency has approved Eli Lilly and Company’s donanemab, a 350 mg/20 mL once-monthly injection for IV infusion, for the treatment of adults with early symptomatic Alzheimer disease (AD). Marketed as Kisunla, donanemab is available to patients with mild cognitive impairment (MCI) as well as those with the mild dementia stage of AD, with confirmed amyloid pathology.¹

…

Considered the third approved antiamyloid therapy, donanemab is the first and only medication with evidence to support stopping treatment when amyloid plaques are removed, which can result in lower therapy costs and fewer infusions.

…

In the low/medium tau population, LSM change from baseline in the iADRS score at 76 weeks was –6.02 (95% CI, ­–7.01 to –5.03) in the donanemab group and ­–9.27 (95% CI, –10.23 to ­–8.31) in the placebo group, resulting in a 35.1% (95% CI, 19.90-50.23) slowing of disease progression. The impacts were less pronounced in the overall population, with between-group score differences of 2.92 (95% CI, 1.51-4.33; P <.001), representing a 22.3% (95% CI, 11.38-33.15) slowing of disease progression.”

IN SHORT:

The Phase 3 trials of donanemab also included Australian patients.  It has been described as a ‘game changer’ because not only does it slow progression like the two other drugs in this class, it can be discontinued after the amyloid deposits are removed.  It does raise the question of when/if it will be approved by the Therapeutic Goods Administration, noting that it also has significant side effects.

1 July 2024

Commonwealth Government puts up $20M to commercialise AI to unlock neurocognitive secrets

Commercialising A.I. to unlock the mystery of multiple sclerosis

“The Australian Government is investing $20 million to commercialise digital health research, taking it from the lab and putting it in the hands of patients and their health team, like using artificial intelligence to unlock the secrets of neurological disorders like multiple sclerosis and dementia.

To realise the potential of Australia’s world-class digital health research, ANDHealth+ received $19.75 million through the Medical Research Future Fund’s (MRFF) Medical Research Commercialisation initiative.

Each company is awarded a share of $3.75 million in equity-free funding, alongside hands-on support by a network of experts to help them to scale their businesses.

The MRFF investment has now supported 21 companies to turn their research into real treatments and products for Australians.”

Minister Mark Butler stated “The potential of Australian researchers and our digital health technology sector is unlimited…Investment is important, but so too is expert guidance to navigate the pathway from discovery to delivery for Australian patients.”

IN SHORT:

Neurocognitive disorders are at the cutting edge of research that uses artificial intelligence (AI).  Australia is getting behind innovation in the field.  Keep an eye out for results that could deliver practical improvements for people with neurocognitive disorders.

1 July 2024

Dementia UK calls out gaping hole in dementia nursing care in British hospitals

Open letter calls for increased access to dementia nursing in hospitals

“Access to specialist dementia nursing in hospitals must increase to ensure people with the condition receive appropriate care, a leading charity has urged.

Dementia UK has delivered an open letter calling on the next government to address the ‘huge gaps’ in health and social care which it says are leaving people with dementia ‘isolated and unsupported’.

The letter, addressed to all political parties and signed by 13,000 people, echoes demands from the charity’s recently published manifesto ‘Put dementia on the agenda’.”

IN SHORT:

Along with other concerns about the UK National Health Service (NHS), now comes the call for urgent action to lift the quality of dementia nursing care in British hospitals.  This comes after recent reports about hospital care for people with dementia in Australia.

26 June 2024

Plasma p-tau181: A Potential Biomarker for Psychosis Risk in Alzheimer Disease

Question  

Are longitudinal changes in levels of plasma tau phosphorylated at threonine 181 (p-tau181) and neurofilament light chain protein (NfL) associated with the emergence of psychotic symptoms in the context of Alzheimer disease (AD)?

Findings  

In this cohort study of 752 patients with mild cognitive impairment (MCI) and AD, the emergence of psychotic symptoms (delusions and hallucinations) was associated with increases in plasma p-tau181 and NfL levels.

Meaning  

Findings suggest that plasma levels of p-tau181 and NfL may be used as a biomarker for psychosis in MCI and AD, with potential implications for disease monitoring and treatment strategies.

13 June 2024

A healthy diet in childhood may protect against cognitive decline

Associations Between Dietary Pattern and Global Cognitive Ability Trajectories Across the Life Course: Longitudinal Analysis of the 1946 British Birth Cohort

A study has identified links between dietary patterns from childhood and later cognitive ability using longitudinal data. “Our results suggest dietary patterns in midlife, before age 50, may be most predictive of cognitive trends up to age 69. Future research should follow younger cohorts and plan earlier diet interventions.”

IN SHORT:

These researchers looked at the diets of people at five time points and their cognitive ability at seven time points. Perhaps not surprising, the quality of the diet was closely linked with cognitive ability.  The results are pretty stark.  For example, only 8% of people with low-quality diets had sustained high cognitive ability, and only 7% of individuals who had high-quality diets had low cognitive ability over time compared with their peers.

If you needed another reason to eat a balanced diet of fresh wholefoods – look no further.  And it’s never too late – see this easy to digest write up.

12 June 2024

New study shows that diabetes accelerates cognitive decline

Diabetes accelerates Alzheimer’s disease progression in the first year post mild cognitive impairment diagnosis 

A new study shows a link between type 2 diabetes and development of Alzheimer’s disease.  Specifically, the study found:

• Diabetes mellitus (DM) accelerates mild cognitive impairment (MCI)-to-Alzheimer’s disease (AD) progression within the first year after MCI diagnosis.
• DM leads to sharper cognitive decline within 12 months of follow-up.
• There is notable nucleus accumbens atrophy observed in MCI patients with DM.
• DM causes significant reductions in gray matter volume and sulcal depth.
• There are stronger correlations between cognitive decline and brain changes due to DM.

IN SHORT:

Those people with mild cognitive impairment (MCI – the first stage of dementia) and type 2 diabetes appear to progress to Alzheimer’s disease more rapidly than those who do not have diabetes.  This aligns with other studies which highlight the role of role of glucose control in the development of dementias.  It may surprise you to learn that Alzheimer’s disease is sometimes referred to as type 3 diabetes (see this explanation by Diabetes Australia).

April 2024

Low cost, high quality dementia care in Thailand is drawing Australians living with fatal condition

Australia’s failing aged care is driving dementia patients overseas

“It’s never easy losing someone you love, but what’s even worse is having to grieve for them while they’re still alive.

That’s the cruel reality of dementia.

And like so many Australians, I’m living it.

My mum, Lorraine, has had the disease for more than 10 years and now lives in a nursing home in Sydney.

With no cure and no effective treatment, watching mum slowly surrender to her failing mind has been excruciating.It makes you think there must be a better way.

And it turns out, there is – in Thailand.

The town of Chiang Mai is full of luxury resorts, where people with dementia can have their own carer 24 hours a day.”

IN SHORT:

This 60 Minutes story showcases the development of a new form of health tourism.  Enclaves in Thailand are marketing to Australians and their families who have dementia, including those with young onset dementia.  The attraction is easy to see – lower cost personal care, resort style living and an accepting community.  However, the decision to move to Thailand also means that you are leaving behind your friends and community, giving up access to the Australian health system, assuming that you will die before the money runs out, and living without the protection of citizenship or permanent residency.

Perhaps some would say it’s not a bad bargain if the quality of care is what is shown in the marketing material.  But it does highlight the significant way we have to go in Australia in care  for people with dementia – both young and old.