Experts call for better diagnostics as Alzheimer's drug rollout begins

Taipei, June 25 (CNA) As Taiwan begins administering two newly approved drugs for early-stage Alzheimer's disease, medical experts on Wednesday said more accurate diagnostic tools are needed to identify suitable patients and guide treatment decisions.

Diagnosing Alzheimer's is not easy, and precise biomarkers are needed to assist physicians in making accurate assessments, Chang Chiung-chih (張瓊之), deputy head of Kaohsiung Chang Gung Memorial Hospital's Department of Neurology, said at a press event in Taipei.

To accurately identify the disease, doctors often need to spend a lot of time communicating with a new patient's family and asking about the patient's daily functioning, Chang said, including whether they can still shop for groceries or perform basic calculations.

With two newly approved drugs for early-stage Alzheimer's -- Leqembi and Kisunla -- beginning to be administered across Taiwan, more accurate diagnostic tools are needed to identify patients in the early stages who are suitable for treatment, Chang said.

Kisunla, developed by U.S. pharmaceutical company Eli Lilly, and Leqembi, jointly developed by Eisai in Japan, Biogen in the U.S. and BioArctic in Sweden, were approved by the Taiwan Food and Drug Administration (TFDA) earlier in 2025 for use in Taiwan.

They were approved by the United States Food and Drug Administration in 2024 (Kisunla) and 2023 (Leqembi).

Some patients in Taiwan began receiving the two drugs earlier this week, but are doing so at their own expense because the drugs are currently not covered by the national health insurance (NHI) system.

A standard 18-month course for each of the two drugs costs around NT$1.5 million (US$50,829).

Chang said researchers believe Alzheimer's disease is caused by the combined accumulation of amyloid and tau protein in the brain, and that the presence of tau protein is closely linked to the onset of symptoms -- the broader the tau spread, the more severe the cognitive decline.

Based on the correlation between tau protein deposition and the onset of Alzheimer's, she hoped that in the future, medical imaging for tau protein will enable earlier detection and help predict disease progression.

Echoing Chang, Hsu Jung-lung (徐榮隆), president of the Taiwan Dementia Society, said current diagnostic methods for Alzheimer's rely on assessment scales and clinical guidelines to determine whether a patient "very likely" has the disease.

Biomarkers are therefore critical to confirming an Alzheimer's diagnosis, and such indicators could help determine whether a patient is eligible for the new treatments that may slow the disease's progression, he said.

Jang Ming-kuei (張明奎), founder of transnational biotech company Aprinoia, said a tau protein imaging agent developed by his company can visualize tau protein accumulation in the brain, though the agent is still undergoing clinical trials in dementia patients.

Jang said the company is in discussions with the TFDA regarding its drug approval application, including the submission of safety and efficacy data.

An estimated 350,000 people in Taiwan have some form of dementia, with 60-70 percent of them having Alzheimer's. About half, or fewer than 100,000 patients, may qualify for the new treatments, according to Yan Sui-hing (甄瑞興), director of Far Eastern Memorial Hospital's dementia center.