Alzheimer’s Disease Medications: Better than nothing but at what Cost?
Currently, only two medications are approved for modifying the progression of Alzheimer’s Disease. These include Kisunla and Leqembi. Aduhelm was discontinued in 2024.
In a phase 2 clinical trial, funded by its manufacturer Eli Lily, Kisunla was shown to meet it’s primary objective. Unfortunately, it failed to provide substantial differences in important secondary objectives. There were also safety concerns among patients taking the medication.
The primary objective of this trial was to show that Kisunla improves the Integrated Alzheimer’s Disease Scale (iARDS) compared to placebo treatment after 72 weeks. The iARDS is a tool that measures both cognitive and functional impairment in Alzheimer’s Disease.
The study reported improvements in iARDS after 76 weeks of treatment with Kisunla, with a 3.20 point improvement compared to group not treated with the medication (placebo group).
The secondary objective of this study was to show improvement in multiple tools used to assess Alzheimer’s Disease such as Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB), the 13-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-Cog13), the Alzheimer’s Disease Cooperative Study–Instrumental Activities of Daily Living Inventory (ADCS-iADL), and the Mini–Mental State Examination (MMSE).
Unfortunately, the results show that Kisunla failed to provide substantial improvement in these important secondary objectives.
In addition, Kisunla also did not show significant reduction in the beta amyloid and tau protein levels on brain PET scans nor did it show improvement in brain volume when compared to placebo.
Authors of this study concluded that “Longer and larger trials are necessary to study the efficacy and safety of donanemab in Alzheimer’s disease”.
The updated phase 3 clinical trial entitled TRAILBLAZER-ALZ 2 had different results.
Similar assessment tools used in the phase 2 trial were used in this trial. The findings show that after 76 weeks of treatment, Kisunla slowed the clinical progression of Alzheimer’s Disease in participants when compared to the group receiving placebo. Although the results are statistically significant and the improvements are mediocre, its progress.
But at what risk? Let’s discuss it’s safety.
Kisunla is given intravenously and common side effects include headache and mild to severe infusion-related reactions.
More serious side effects of Kisunla, include Amyloid-Related Imaging Abnormalities (ARIA) which includes brain swelling (edema) and/or brain bleeds (microhemorrhages).
In the TRAILBLAZER-ALZ 2 mentioned earlier, 36.8% of patients treated with Kisunla experienced ARIA compared to 14.9% in the placebo group. Brain bleeds occurred in 26.8% in the Kisunla group, vs 12.5% in the placebo group. Patient’s with the APOE4 genetic variant were at higher risk of developing ARIA; 40.6% of homozygous APOE4 patients developed ARIA. Three deaths occurred due to these side effects in this clinical trial.
Although approved by the FDA, safety concerns have been so far reaching that the European Medicines Agency, Europe’s version of the FDA, has rejected approval of Kisunla.
Isn’t there another medication for Alzheimer’s Disease? Yes, but it also brings the same safety concerns.
Is Leqembi safer? No, this medication shows high risk of serious side effects too.
Similar to Kisunla, Leqembi (Lecanemab), is anti-amyloid medication used modify the progression of Alzheimer’s Disease. It also has been shown to cause ARIA and upon gaining FDA approval in 2023, Leqembi received a black box safety warning.
A post marketing analysis of Leqembi published in January 2025 reported a rapid increasing trend of reported side effects. They also identified several sides effects not reported in clinical trials including tremors, migraine and pancreatic cancer. Their “Results provide evidence for healthcare professionals and patients to weight the risks and benefits of lecanemab treatment”.
A report from the FDA published in August 2025 echoed these significant safety concerns. After identifying six deaths early in the Leqembi treatment protocol and 101 cases of serious ARIA occurring before the 5th infusion, the FDA is now recommending additional and early MRI scans to patients taking this medication.
When considering any medical treatment the doctor and patient must consider the benefits and risks. The patients also must consider health insurance coverage and cost.
Kisunla is estimated to cost $12,500 for a 6 month course, $32,000 for a 12 month course and over
$48,000 for an 18 month course.
Leqembi is estimated to cost $26,500 for a 12 month course. Your out of pocket cost for treatments will depend on your benefit plan, length of treatment, imaging tests and other charges.
Already taking these medications and want another option? Your doctor prescribed it but you’re concerned about these potential side effects?
Valley Integrative Health offers early screening, thorough assessment and comprehensive evidence based treatment of Alzheimer’s Disease.
Learn more at www.VIHclinic.com
SOURCES:
https://www.nejm.org/doi/full/10.1056/NEJMoa2100708
https://pmc.ncbi.nlm.nih.gov/articles/PMC12280727/
https://pmc.ncbi.nlm.nih.gov/articles/PMC11497759/
https://www.drugs.com/medical-answers/what-controversy-surrounding-leqembi-3578212/
https://alzres.biomedcentral.com/articles/10.1186/s13195-024-01669-4