‘Leqembi enables prevention of Alzheimer's disease’

Duk Lyul Na, Director of Happymind Clinic

New Alzheimer's drug Leqembi is approved in Korea...only treatment option available

Effective in early dementia patients..."Recommend active treatment”

Duk Lyul Na, Director of the Happymind Clinic (former Professor of Neurology at Samsung Medical Center,),

"Now that there is a treatment for Alzheimer's disease, we can prevent dementia by 90% if it is detected early.

 

With better drugs expected to be developed in the future, we should provide timely treatment for the patients so they can live to grasp that new opportunity." Duk Lyul Na, Director of the Happymind Clinic (former Professor of Neurology at Samsung Medical Center,), stressed the importance of treating Alzheimer's disease early during a meeting with Dailypharm.

 

Alzheimer's disease has been one of the unexplored areas of treatment.

 

Since the hypothesis that Alzheimer's disease is caused by amyloid beta emerged, drugs targeting amyloid beta were developed, to no effect.

 

One such drug was Eisai’s Aduhelm (aducanumab).

 

Because the amyloid beta hypothesis was first received with doubt at the time, there was not much trust in the drug, but it showed an effect.

 

However, Aduhelm was withdrawn from the market due to its high price and concerns about side effects.

 

Then came Leqembi (lecanemab-irmb).

 

Developed by Eisai and Biogen, Leqembi has shown efficacy in early-stage Alzheimer's disease in clinical trials and has cleared the regulatory hurdles in South Korea, the United States, Japan, and China.

 

The introduction of Leqembi has raised hopes of conquering dementia by allowing a more fundamental treatment that goes beyond symptom relief.

 

Director Na emphasized that treatments that target amyloid beta are more likely to make a difference than those that do not, and that starting treatment at the earliest stages of dementia is key to maximizing the treatment effect.

 

Leqembi delays disease progression by 27% in phase III trial Leqembi, the first drug approved in Korea, was shown to delay the rate of Alzheimer's disease progression by 27% compared to placebo in the Phase 3 Clarity AD study.

 

The study compared the efficacy and safety of Leqembi versus placebo in 1,795 patients aged 50 to 90 years with early Alzheimer's disease who had evidence of brain amyloid accumulation on positron emission tomography (PET) or cerebrospinal fluid tests.

 

Study results showed that the primary endpoint, the Clinical. Dementia Rating Sum of Boxes (CDR-SB) score at 18 months post-dose, was 1.21 in the Leqembi arm.

 

This was lower than the 1.66 recorded by the placebo group.

 

Higher scores indicate worse symptoms.

 

One of the secondary endpoints, change in amyloid deposition via PET, was also reduced in the Leqembi arm starting at 3 months after administration.

 

"In other diseases, such as diabetes and cancer, patients often get better with treatment, but in brain diseases, stopping disease progression is near a miracle.

 

The 27% effect in slowing disease progression compared to placebo includes patients with mild cognitive impairment and early Alzheimer’s type dementia.

 

If treatment is started at an earlier stage, we expect the effect to be greater.” But there are concerns about side effects.

 

In the trial, Leqembi’s incidence of ARIA-E with cerebral edema was 12.6%, and ARIA-H with cerebral hemorrhage was 17.3%.

 

"Aducanumab, which was introduced before Leqembi, had a reported ARIA-E rate in the 40% range, but in the real world, the rate was about 19%, not as high as in clinical studies.

 

In the field, the dose was increased more slowly than standard and patients were monitored via MRI every month, so we were able to respond early to side effects " "Therefore, Leqembi’s side effects can also be managed by closely monitoring patients and proactive management.

 

For reference, the high cost of MRI in the U.S.

 

makes it difficult to perform frequent MRI tests, but Korea has a relatively favorable environment for frequent testing." "First new drug for Alzheimer’s in Korea...Early Alzheimer's patients should be treated aggressively with the drug” Director Na stressed how patients should be aggressively treated with the introduction of the first new drug for Alzheimer's disease.

 

According to Dr.

 

Na, the treatment effect for Alzheimer's disease is not high if it is detected and treated at the middle or early to mid-stage of the disease.

 

"If there is even a small amount of brain atrophy found via MRI, there is a high probability that the amyloid PET test will be positive.

 

Therefore, if you can afford it, I recommend taking the APOE gene test.

 

Depending on the results, you can confirm Alzheimer's lesions with an amyloid PET test.

 

The best option is to remove amyloid beta from the brain while the patient’s cognitive function is still normal." "The earlier we can treat the disease, the less financial and disease burden it can cause.

 

Also, if we can maintain the disease without progression, another opportunity may come for the patients to be treated when new therapies become available." In particular, Na noted that if the disease is left untreated in the early stages, it can become more costly and distressing for the patients and their families.

 

Treatment with lecanemab is expected to cost KRW 20 to 30 million annually.

 

If the patient starts treatment in the early stages of Alzheimer's disease when there are no symptoms and the amyloid beta is cleared, the cost spent will be enough to cure the condition.

 

However, if symptoms appear and the disease progresses to dementia, it is likely to cost an additional KRW 300 to 500 million per month in care costs alone.

 

Na explained, “I have been treating dementia patients for more than 30 years, and I have seen how dire the situation is for patients with amyloid beta accumulation in the brain.

 

In practice, the ratio of positive and negative amyloid PET scans in patients with mild cognitive impairment is about 50 to 50.

 

And the difference between the two patient groups increases over time.

 

As the disease progresses, the friction between patients and their caregivers increases and the burden of care becomes significantly higher.

 

In this sense, Leqembi is an essential treatment that can alleviate the suffering of these families." "We now live in a world where Alzheimer's can be prevented 90% of the time if it is detected in advance.

 

If the patient’s amyloid PET test comes out negative, it is also good as they can enjoy the rest of their life without concern.

 

I ask patients to receive testing in advance and become aware of their condition.

 

This way they can live without vague fears and prevent dementia.”