"Dementia, Early Diagnosis is Important"

Dementia is one of the diseases that affects not only the patients but also the quality of life of their families. Due to its high social cost, various attempts to address dementia are ongoing not only domestically but also internationally.

GemVax, which is developing a dementia treatment drug, explained that in the absence of a dementia treatment drug, early diagnosis through testing is the best option.

According to data from the Ministry of Health and Welfare in 2019, among the elderly population aged 65 and over, which numbers 7.72 million, the number of dementia patients reaches 860,000. The prevalence rate of dementia is 11.2%, meaning one out of every ten elderly people suffers from dementia. As the society enters a super-aged phase, it is projected that by 2050, the number of dementia patients will reach 3 million.

Since 2017, the government has implemented the ‘National Responsibility System for Dementia,’ and the K-MMSE test has been considered one of the essential examination items when determining dementia status. It is an assessment tool used to determine whether the examinee has cognitive impairment, classified into ▲orientation to time ▲orientation to place ▲registration and recall ▲attention and calculation ability ▲basic language ability ▲visuospatial construction ability. The total score is out of 30 points, with 20?26 points classified as mild dementia, 10?19 points as moderate dementia, and 0?9 points as severe dementia.

The MMSE, the most widely used dementia screening test worldwide, is a simple test and therefore is not used to confirm dementia or distinguish its types. The test results are influenced by age and education level, and score variations occur depending on the examiner’s skills and judgment criteria. It is a simple screening test that can be conducted at nearby public health centers.

Dementia involves not only cognitive decline but also various behavioral disorders in daily life and emotional disturbances, so there are various tests to evaluate it. The diagnostic process is important because appropriate treatment plans can be established according to the severity of dementia and explanations can be provided to caregivers.

While used in medical settings to diagnose dementia, it is also used to evaluate the efficacy of clinical trials conducted to develop dementia treatment drugs. Dementia is a disease with increasing prevalence and is difficult to treat with modern medicine. Aducanumab, the first dementia treatment drug conditionally approved by the U.S. FDA in June last year, was developed jointly by the global pharmaceutical companies Biogen and Eisai. The CDR-SB was used as the primary efficacy endpoint in the clinical trials.

GV1001, developed by GemVax, is the only new drug in Korea to have received approval for phase 3 clinical trials. As an Alzheimer’s treatment drug, the SIB was used as the primary efficacy endpoint in the phase 2 clinical trial. Unlike other treatment clinical trials targeting early and mild dementia patients, GemVax’s GV1001 conducted clinical trials targeting patients with moderate or higher dementia, where brain cell death has already progressed to some extent. GemVax used the SIB, specialized in measuring cognitive ability in patients with moderate or higher dementia, as the primary endpoint.