Update of Brain Image Analysis Program "BRAINEER Model A" Resulting from Joint Research with Tokyo Metropolitan Institute of Gerontology
Splink Inc. has released "BRAINEER Model A version 1.5.0," an updated brain image analysis program developed in collaboration with the Tokyo Metropolitan Institute of Gerontology. This version adds new functions to quantitatively evaluate amyloid changes before and after treatment, responding to the widespread use of Alzheimer's disease therapeutics.
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- 📰 Published: April 27, 2026 at 19:00
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Splink Inc. (Headquarters: Minato-ku, Tokyo; Representative Director: Hiroki Aoyama; hereinafter, "the Company") is pleased to announce the release of "BRAINEER Model A version 1.5.0," following a functional update to our brain image analysis program "BRAINEER Model A" (Certification Number 304ADBZX00025000). This product is a medical device program developed through joint research with the Tokyo Metropolitan Institute of Gerontology, designed to assist in the visual interpretation of amyloid PET images and specifically to support the interpretation of amyloid-beta, one of the causative agents of Alzheimer's type dementia.
### Background of This Product Development Project
This update was realized based on the results of joint research with the Tokyo Metropolitan Institute of Gerontology, and the achievements cultivated under Tokyo's dementia research support initiatives will lead to practical application in clinical settings.
The treatment of Alzheimer's disease is undergoing a major turning point with the advent of disease-modifying drugs targeting amyloid-beta, the causative agent. In 2023, Eisai Co., Ltd.'s "Leqembi® (generic name: Lecanemab)" was approved and launched, followed by Eli Lilly Japan K.K.'s "Kesimpta® (generic name: Donanemab)" in 2024, marking the full-scale implementation of amyloid antibody therapy.
Particularly with "Kesimpta®" treatment, there is a characteristic that administration can be terminated if the removal of amyloid-beta is confirmed by tests such as amyloid PET. This rapidly increases the need in future clinical settings to appropriately and accurately evaluate "how much amyloid-beta has been removed" and to link this to treatment optimization.
Version 1.5.0 addresses this new treatment environment by adding functions that allow for a more intuitive and quantitative understanding of changes before and after treatment. This aims to support healthcare professionals in evaluating treatment efficacy and enabling optimal treatment decisions for each patient.
### Features of "BRAINEER Model A version 1.5.0" New Functions
This update visualizes amyloid changes before and after treatment over time and introduces new indicators for quantitatively evaluating subtle changes. This supports more accurate assessment of treatment effects by physicians. Furthermore, by providing dedicated reports that allow patients and their primary physicians to share treatment effects at a glance, it supports new dementia care in the era of anti-amyloid-beta antibody therapy.
#### 1. "Interpretation Assistance Function" to Capture Pre- and Post-Treatment Changes
The difference display function compares images from multiple time points before and after treatment, visually emphasizing areas where amyloid-beta accumulation has changed. This helps physicians quickly and at a glance detect subtle changes. Furthermore, the introduction of new quantitative indicators is expected to improve the detection sensitivity for minute amyloid-beta accumulation, enabling more precise measurement of treatment effects.
#### 2. "Treatment Evaluation Report" for Patients and Primary Physicians
For patients and primary physicians, the report displays representative PET images and analysis results before and after treatment side-by-side, allowing visual confirmation of treatment effects. In Alzheimer's disease treatment, there are cases where subjective improvement in symptoms is difficult to perceive, but visually understanding changes in the brain is expected to contribute to maintaining patient motivation and reducing anxiety towards treatment, thereby encouraging a proactive approach to treatment.
### About the Brain Image Analysis Program "BRAINEER Model A"
The brain image analysis program "BRAINEER Model A" is a program medical device that supports visual interpretation by physicians by quantitatively analyzing the accumulation of amyloid-beta in amyloid PET images and visualizing it as indicators such as Centiloid, SUVR, and Z-score. By providing this objective and quantitative information, it presents numerical data useful for diagnosis and treatment evaluation, enabling more accurate clinical support.
*The brain image analysis program "BRAINEER Model A" was developed based on the results of joint research with the Neuroimaging Research Team at the Tokyo Metropolitan Institute of Gerontology and obtained medical device approval in 2022.
### Comment from Dr. Kenji Ishii, Tokyo Metropolitan Institute of Gerontology
Alzheimer's disease treatment has entered a new era with the advent of antibody drugs targeting amyloid-beta, which remove the causative substance itself. In future clinical settings, it will be extremely important to appropriately and accurately evaluate the treatment effects (status of amyloid-beta removal) using amyloid PET with these new drugs.
The updated "BRAINEER Model A v1.5.0" is equipped with new functions to visualize subtle changes before and after treatment, contributing to clinical practice.
### Background of This Product Development Project
This update was realized based on the results of joint research with the Tokyo Metropolitan Institute of Gerontology, and the achievements cultivated under Tokyo's dementia research support initiatives will lead to practical application in clinical settings.
The treatment of Alzheimer's disease is undergoing a major turning point with the advent of disease-modifying drugs targeting amyloid-beta, the causative agent. In 2023, Eisai Co., Ltd.'s "Leqembi® (generic name: Lecanemab)" was approved and launched, followed by Eli Lilly Japan K.K.'s "Kesimpta® (generic name: Donanemab)" in 2024, marking the full-scale implementation of amyloid antibody therapy.
Particularly with "Kesimpta®" treatment, there is a characteristic that administration can be terminated if the removal of amyloid-beta is confirmed by tests such as amyloid PET. This rapidly increases the need in future clinical settings to appropriately and accurately evaluate "how much amyloid-beta has been removed" and to link this to treatment optimization.
Version 1.5.0 addresses this new treatment environment by adding functions that allow for a more intuitive and quantitative understanding of changes before and after treatment. This aims to support healthcare professionals in evaluating treatment efficacy and enabling optimal treatment decisions for each patient.
### Features of "BRAINEER Model A version 1.5.0" New Functions
This update visualizes amyloid changes before and after treatment over time and introduces new indicators for quantitatively evaluating subtle changes. This supports more accurate assessment of treatment effects by physicians. Furthermore, by providing dedicated reports that allow patients and their primary physicians to share treatment effects at a glance, it supports new dementia care in the era of anti-amyloid-beta antibody therapy.
#### 1. "Interpretation Assistance Function" to Capture Pre- and Post-Treatment Changes
The difference display function compares images from multiple time points before and after treatment, visually emphasizing areas where amyloid-beta accumulation has changed. This helps physicians quickly and at a glance detect subtle changes. Furthermore, the introduction of new quantitative indicators is expected to improve the detection sensitivity for minute amyloid-beta accumulation, enabling more precise measurement of treatment effects.
#### 2. "Treatment Evaluation Report" for Patients and Primary Physicians
For patients and primary physicians, the report displays representative PET images and analysis results before and after treatment side-by-side, allowing visual confirmation of treatment effects. In Alzheimer's disease treatment, there are cases where subjective improvement in symptoms is difficult to perceive, but visually understanding changes in the brain is expected to contribute to maintaining patient motivation and reducing anxiety towards treatment, thereby encouraging a proactive approach to treatment.
### About the Brain Image Analysis Program "BRAINEER Model A"
The brain image analysis program "BRAINEER Model A" is a program medical device that supports visual interpretation by physicians by quantitatively analyzing the accumulation of amyloid-beta in amyloid PET images and visualizing it as indicators such as Centiloid, SUVR, and Z-score. By providing this objective and quantitative information, it presents numerical data useful for diagnosis and treatment evaluation, enabling more accurate clinical support.
*The brain image analysis program "BRAINEER Model A" was developed based on the results of joint research with the Neuroimaging Research Team at the Tokyo Metropolitan Institute of Gerontology and obtained medical device approval in 2022.
### Comment from Dr. Kenji Ishii, Tokyo Metropolitan Institute of Gerontology
Alzheimer's disease treatment has entered a new era with the advent of antibody drugs targeting amyloid-beta, which remove the causative substance itself. In future clinical settings, it will be extremely important to appropriately and accurately evaluate the treatment effects (status of amyloid-beta removal) using amyloid PET with these new drugs.
The updated "BRAINEER Model A v1.5.0" is equipped with new functions to visualize subtle changes before and after treatment, contributing to clinical practice.