Month: August 2024

Early diagnosis of dementia and Alzheimer’s can be challenging because both conditions share many symptoms with age-related cognitive loss. Researchers at the University of Cambridge have created an artificial intelligence (AI) tool that can forecast if a person with early dementia symptoms would remain stable or develop Alzheimer’s. It was three times more accurate than current clinical standards and may aid in directing patients to suitable treatment early in their illness.

Early diagnosis is essential to arrest the progression of both dementia and Alzheimer’s disease. However, past research indicates that fewer than half of people with dementia symptoms ever receive a diagnosis [1]. Furthermore, it might be challenging to diagnose dementia or Alzheimer’s early on because both conditions overlap symptoms of age-related cognitive loss.

To address this problem, University of Cambridge researchers have created an artificial intelligence (AI) tool that can predict whether an individual with early dementia symptoms would continue to remain stable or develop Alzheimer’s [2]. Journal eClinical Medicine published the findings recently [3].

The AI-Based Tool

Researchers employed cognitive tests and MRI scan data from over 400 people in a US-based research group to develop their AI tool.

They then used data from 600 more participants in the US research group and 900 individuals from memory clinics in Singapore and the United Kingdom to test their AI technology.

The research team trained and tested their AI model on regularly acquired data from research cohorts as well as patients in real-memory clinics to ensure that it could be implemented in a healthcare setting. This demonstrated its applicability in a real-world context.

AI Tool 3 Times More Accurate in Predicting Alzheimer’s Development than Standard Tests

According to the research, the AI-powered tool could distinguish between study participants with stable mild cognitive impairment and those who progressed to Alzheimer’s in three years.

The technique identified 82% of individuals who ultimately had Alzheimer’s disease and 81% of individuals who did not, based solely on MRI scans and cognitive testing.

Researchers found that compared to the current standard of treatment, the AI tool was nearly three times more accurate at predicting the development from early-stage dementia symptoms to Alzheimer’s.

The model also enabled the researchers to divide the population with Alzheimer’s into three groups based on information from each patient’s initial visit to the memory clinic: participants with stable symptoms (approximately 50%), those with a gradual progression of the disease (approximately 35%), and those with a faster progression (15%).

Examining follow-up data spanning six years confirmed these predictions. It is significant because it can help identify patients who may benefit from novel treatments at the early stage and those who require close monitoring since their illness can deteriorate rapidly.

Zoe Kourtzi, PhD, the study’s senior author and an experimental psychology professor at the University of Cambridge, claims that despite employing only data from MRI scans and cognitive tests, their tool is far more sensitive than existing methods at predicting whether a person will progress from mild symptoms to Alzheimer’s and, if so, how quickly.

She stated that this AI tool has the potential to significantly enhance patient well-being by identifying which patients require the closest care and relieving anxiety in those patients who will remain stable. This will also help eliminate the need for unnecessary invasive and expensive diagnostic testing.

Alzheimer’s Research Association is a non-profit organization dedicated to helping caregivers of Alzheimer’s disease and dementia. We provide the latest information and news about the illness and helpful tips to help caregivers cope with their daily caregiving challenges. We realize the most important thing that a caregiver needs is financial assistance. Therefore, we provide grants to caregivers to ease their financial burden. Caregivers can apply for grants here: Alzheimer’s Grant Application.

You can also help caregivers in their endeavor by donating as much as possible: Donation To Alzheimer’s Research Associations.

References

1. Advancing Early Detection. Alzheimer’s Disease and Healthy Aging. CDC. https://www.cdc.gov/aging/healthybrain/issue-maps/early-detection.html. Accessed: 13th August, 2024.
2. Artificial intelligence outperforms clinical tests at predicting progress of Alzheimer’s disease. University of Cambridge. https://www.cam.ac.uk/research/news/artificial-intelligence-outperforms-clinical-tests-at-predicting-progress-of-alzheimers-disease. Published Online: 12th July, 2024. Accessed: 13th August, 2024.
3. Lee, L.Y., Vaghari, D., Burkhart, M.C., Tino, P., Montagnese, M., Li, Z., Zühlsdorff, K., Giorgio, J., Williams, G., Chong, E. and Chen, C., 2024. Robust and interpretable AI-guided marker for early dementia prediction in real-world clinical settings. EClinicalMedicine.
4. Scientists create AI tool that helps predict Alzheimer’s with up to 82% accuracy. Medical News Today. https://www.medicalnewstoday.com/articles/ai-outperforms-clinical-tests-4-out-of-5-at-predicting-progress-of-alzheimers-disease. Published Online: 19th July, 2024. Accessed: 13th August, 2024.
5. AI tool predicts Alzheimer’s better than standard tests. News Nation. https://www.newsnationnow.com/health/ai-predicts-alzheimers/. Published Online: 16th July, 2024. Accessed: 13th August, 2024.

The Food and Drug Administration approved a new medication on July 2, 2024, for Alzheimer’s treatment [1]. The drug, Kisunla, is the third in a new class of treatments to slow disease progression. It bears similarities to Leqembi, a medication that was authorized for use in early-stage Alzheimer’s patients last year [2]. Another drug in this class, Aduhelm, was approved by the FDA in 2021 but was withdrawn from the market earlier this year [3].

Eli Lilly’s Kisunla is a monoclonal antibody that is part of a new class of Alzheimer’s medications designed to address the disease pathology as it progresses across the brain, not just relieve symptoms. Clinics worldwide have been undertaking comprehensive phase 2 and, subsequently, phase 3 clinical trials of Kisunla, also known by its generic name donanemab, for the past four years.

Here’s everything you need to know about Kisunla, the newly FDA-approved Alzheimer’s drug.

What is Kisunla?

Kisunla belongs to a novel class of Alzheimer’s medications termed monoclonal antibody (mab) anti-amyloid drugs.

Monoclonal antibody drugs, or “mab” drugs for short, are used to treat a variety of disorders, including cancer. These medicines are intended to attach to a single antigen and may be employed alone or in combination with other substances to target the desired cells.

Since some mab medications aid the immune system in identifying and eliminating specific target cells, they are regarded as immunotherapies.

In the case of Alzheimer’s treatment, researchers have used this technology to target beta-amyloid protein cells, the disease’s most recognized and longest-targeted biomarker. Alzheimer’s patients’ brains accumulate amyloid proteins, which form clumps that impair brain cell function and ultimately result in cell death. Some scientists believe that the clumping protein process is the source of Alzheimer’s progression. That is undoubtedly one of the most prevalent pathological features of the illness, regardless of whether it is the cause.

These Alzheimer’s anti-amyloid mab medicines are the disease’s first disease-modifying treatments, as they do more than only treat the symptoms. They function at the pathological level to prevent the accumulation of amyloid plaques in the brain. Leqembi binds to beta-amyloid before plaque formation, whereas Kisunla binds to beta-amyloid after plaque formation.

The world’s first mab medication, Aduhelm (aducanumab), followed the latter strategy as well. The FDA conditionally approved it in 2021, but the drug company terminated it in 2024 due to its underperformance [4].

How Effective is Kisunla?

The new medication may delay memory and thinking problems in Alzheimer’s patients in their early stages. However, it is not a cure and cannot reverse memory decline or other symptoms. It is manufactured by Eli Lilly and tested under the name donanemab.

Researchers investigated Kisunla in 1,736 men and women in the early stages of Alzheimer’s. Their ages ranged from 59 to 86 years, with a mean of 73 years. Each participant exhibited tau tangles, proteins that build up and cluster inside neurons as the disease worsens, and the characteristic plaques of Alzheimer’s in their brains.

After 18 months, donanemab reduced thinking and memory decline by four-and-a-half to seven-and-a-half months compared to trial participants who received a placebo. Compared to less than a third of individuals who received a placebo, nearly half of those who received donanemab maintained their cognitive level after a year in the study.

Benefits were highest in individuals with the least severe symptoms, in those under 75, and in those with the lowest brain tau levels. Most patients who received the medication also had a reduction in amyloid plaques in their brains.

Crucially, neither Kisunla nor Leqembi can reverse or heal already-caused brain damage, and the benefits are limited and may go unnoticed by family members.

Who could benefit from Kisunla?

Kisunla, like its predecessor Alzheimer’s medications, was licensed for persons in the early stages of the disease before symptoms become highly disruptive to daily life.

The therapy demonstrated some benefit for people with mild cognitive impairment, which frequently develops into Alzheimer’s, as well as for individuals in the early stages of the condition. However, if the condition is further advanced and there has been significant brain damage, it generally won’t help.

The medicine is described on the label as an amyloid-targeting treatment for individuals with mild cognitive impairment (MCI) and mild dementia stage of early symptomatic Alzheimer’s, with verified amyloid pathology.

Not every incidence of MCI will develop into Alzheimer’s or another type of dementia, and in some, there are other treatable underlying reasons. However, there is a greater likelihood that MCI is the clinical expression of the early stages of Alzheimer’s if amyloid is present.

Experts say there is a need for more precise, easily accessible diagnostics that can identify Alzheimer’s earlier in the disease process, ideally before symptoms even arise. The earlier in the course of the disease that the individuals took the medicine, the more improvement they had in the trials.

How is the medication given?

An intravenous injection of Kisunla is administered every four weeks, usually at a clinic or hospital. Giving an infusion via needle insertion into the arm usually takes thirty minutes or less. Leqembi is administered intravenously as well, but every two weeks.

Infusion patients may develop fever, nausea, symptoms similar to the flu, facial, lip, or mouth swelling, sweating, and other adverse effects. Following the administration of Kisunla, you will be observed for at least thirty minutes for any allergic reaction.

One significant distinction between Leqembi and Kisunla is that patients on Kisunla can discontinue treatment if PET brain scans reveal low levels of beta-amyloid. (Those on Leqembi keep taking the medication.) In the clinical trial, 17% of the participants discontinued the medicine after six months, 47% after a year, and 69% after 18 months.

Cognitive decline may continue diminishing even after patients stop using the medication, though Eli Lilly is investigating how long the advantages may remain.

Is Kisunla safe?

The therapy has side effects similar to Leqembi, such as temporary brain swelling that could be followed by bleeding spots inside or near the surface of the brain. Although bleeding and swelling are typically mild and asymptomatic, they can occasionally be more severe and even fatal.

Continuous monitoring of the patients is necessary, and doctors and patients must carefully consider the benefits and hazards of administering the medicine. Another commonly reported side effect is headache.

Brain swelling and bleeding are more likely in those individuals who have two copies of APOE-E4, a common gene variant that increases Alzheimer’s risk. Therefore, before beginning the medication, patients must undergo testing to ascertain their APOE-E4 status. Doctors will use MRI brain scans to check for brain bleeding and swelling before and during therapy.

Blood-thinning medications, which doctors frequently give to prevent or cure strokes, may increase your risk of experiencing bleeding in the brain. These medications prevent blood clots from forming. Consult your doctor to know whether you take any drugs that raise this risk.

What is the cost of Kisunla?

Kisunla treatment costs $32,000 per year, compared to $26,000 for Leqembi. Some patients might only need to take it for six months, which would cost $12,522, while others might need to take it for eighteen months, which would cost $48,696.

In contrast to Leqembi treatment, patients can discontinue the therapy once scans demonstrate that beta-amyloid has been eliminated from the brain, potentially saving money overall.

Further costs include brain scans and more medical care needed to monitor patients. Depending on the patient, Medicare may pay for all or part of the expenses.

Alzheimer’s Research Association is a non-profit organization dedicated to helping caregivers of Alzheimer’s disease and dementia. We provide the latest information and news about the illness and helpful tips to help caregivers cope with their daily caregiving challenges. We realize the most important thing that a caregiver needs is financial assistance. Therefore, we provide grants to caregivers to ease their financial burden. Caregivers can apply for grants here: Alzheimer’s Grant Application.

You can also help caregivers in their endeavor by donating as much as possible: Donation To Alzheimer’s Research Associations.

References

1. FDA approves treatment for adults with Alzheimer’s disease. U.S. Food and Drug Administration. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease. Published Online: 2nd July, 2024. Accessed: 5th August, 2024.
2. FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment. FDA News Release. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment. Published online: 6th January, 2023. Accessed: 5th August, 2024.
3. Hassan, C. and Christensen, J. Biogen discontinues Alzheimer’s medication Aduhelm. CNN. https://edition.cnn.com/2024/01/31/health/aduhelm-alzheimers-biogen/index.html. Published Online: 31st January, 2024. Accessed: 5th August, 2024.
4. 7 Things to Know About New Alzheimer’s Drug Kisunla. Being Patient. https://www.beingpatient.com/7-things-to-know-about-new-alzheimers-drug-kisunla/. Published Online: 15th July, 2024. Accessed: 5th August, 2024,
5. 5 Things to Know About Kisunla, the New Alzheimer’s Drug. Fisher Center for Alzheimer’s Research Foundation. https://www.alzinfo.org/articles/treatment/5-things-to-know-about-kisunla-the-new-alzheimers-drug/. Published Online: 3rd July, 2024. Accessed: 5th August, 2024.