The Alzheimer's Digest: July 2024

Sunday, July 7, 2024

FDA approves new treatment for Alzheimer’s disease

Alzheimer’s disease currently affects more than 6.5 million Americans. The irreversible, progressive brain disorder slowly destroys memory, thinking skills, and overtime, the ability to carry out simple tasks. Even though the specific causes of the disease are not fully known, traits of Alzheimer’s are seen through changes in the brain, including amyloid beta plaques and neurofibrillary. These changes result in the loss of neurons and their connections, affecting a person’s ability to remember, think, and speak.

Recently, the US Food and Drug Administration approved Kisunla (donanemabazbt), an injection for the treatment of Alzheimer’s disease. The organization said the new treatment should be used in patients with mild cognitive impairment or at the mild dementia stage of the disease. Kisunla should also be administered as an intravenous infusion every four weeks.

The efficacy of the treatment was studied in a double-blind, placebo-controlled, parallel-group study in patients with Alzheimer’s disease. Before the start of the study, patients had confirmed presence of amyloid pathology and mild cognitive impairment or mild dementia stage of disease. The study population had a mean age of 73 years, with a range of 59 to 86 years. 57% of patients were female, 91% were White, 6% were Asian, 4% were Hispanic or Latino, and 2% were Black.

For the first three doses, 1,736 patients were randomized 1:1 to receive 700 mg of Kisunla every four weeks and then 1,400 mg every four weeks or placebo for a total of up to 72 weeks. The treatment was switched to placebo based at Weeks 24, 52, and 76 on a prespecified reduction in amyloid levels measured by positron emission tomography (PET).

Patients who were treated with Kisunla showed a significant reduction in clinical decline on the Integrated Alzheimer’s Disease Rating Scale (iADRS), the Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-Cog13), and the Alzheimer’s Disease Cooperative Study – instrumental Activities of Daily Living scale (ADCS-iADL), compared to placebo at Week 76. Patients with Kisunla also demonstrated a significant reduction in clinical decline on the Clinical Dementia Rating Scale, compared to placebo at Week 76.

While Kisunla has been approved, it’s safety information is important to note. When prescribed, the treatment comes with a boxed warning for amyloid-related imaging abnormalities (ARIA). ARIA presents itself as temporary swelling in areas of the brain, usually resolving over time. It also is accompanied by small spots of bleeding in or on the surface of the brain. Typically, ARIA does not have symptoms.

The most common side effects of Kisunla were ARIA and headache. The full prescribing information about Kisunla and its risks can be found here.

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Saturday, July 6, 2024

New dementia cost model looks to lower financial toll for patients, families

Researchers from the University of Southern California (USC) are building a dementia cost model that will generate comprehensive national and annual estimates of the cost of dementia. With a five-year, $8.2 million federal grant from the National Institute of Aging, the new model could benefit patients and families by assisting families living with dementia by planning their budgets and support needs. It could also inform treatment and caregiving options, as well as shape health care policy.

Currently, the costs attributed with dementia drastically hurt families, draining their savings and causing caregivers to leave their jobs. In the US, the condition is an economic burden, with total health care and long-term care costs for individuals with Alzheimer’s or other dementias projecting to reach $360 billion this year. The Alzheimer Association even projects that this total will reach nearly $1 trillion by 2050.

Project advisor Maria Aranda, a professor at the USC Suzanne Dworak-Peck School of Social Work, said, “Other consequences may include caregivers’ lower retirement savings or limited ability to send their children to college. In turn, this leads to an intergenerational transmission of inequality and financial vulnerability for families of persons with dementia.”

The new model, known as a “dynamic microsimulation model,” will incorporate several data sets, including data from CMS. It will also account for costs across a range of disease stages, such as those acquired by the person living with dementia, their care partners and care givers, and their payers. Additionally, the model’s estimates will adjust for prevention and treatment innovations.

“Once you factor in the social costs of Alzheimer’s — how it affects family, caregivers and others — you quickly realize it is not just an illness but a social epidemic,” Dana Goldman, co-leader of the research team, said. “This project will help amplify the importance of finding treatments that forestall the devastation.”

USC Viterbi scientists will design an interface in the model, which will be available to the public and user-friendly. Researchers will be able to calculate numerous factors that affect dementia patients and their families, like the social and economic impact of drugs that treat the neuropsychiatric symptoms associated with advance dementia. This will keep patients out of hospitals and emergency rooms.

Interestingly, the tool may be able to measure cost savings provided by a new drug, Leqembi, delaying by two months the expense of 24-hour care.

Julie Zissimopoulous, a professor at the USC Price School of Public Policy and head leader of the project, said she and her research team want to know about the future implications of the drug, including its efficacy in patients overtime, particularly for 10 to 20 years.

“Leqembi is a great example,” Zissimopoulous said. “It’s a new FDA-approved treatment for early-stage Alzheimer’s; we have data from clinical trials that informs patients and the health care providers about safety and efficacy. But these data are not informative about the other outcomes patients and their families care about including quality of life impacts that may result from this slowing of cognitive decline. And we want to know about not just the 18 months of the clinical trial, but we want to know about them for 10 years, for 20 years.”

With this new infrastructure, researchers hope it’ll further understanding of dementia progression and how to delay its symptoms.

“Once you factor in the social costs of Alzheimer’s — how it affects family, caregivers and others — you quickly realize it is not just an illness but a social epidemic,” Goldman said. “This project will help amplify the importance of finding treatments that forestall the devastation.”