Speakers - 2025

Abstract

Background: Alzheimer's disease is a progressive neurodegenerative disorder that not only causes disorders in neurocognitive functions such as memory, attention, and executive function, but also exhibits various behavioral psychological symptoms such as agitation, aggression, depression, anxiety, and wandering. In particular, behavioral psychological symptoms of dementia(BPSD) place a serious physical and mental burden on patients and their caregivers. It has also been reported that a decrease in acetylcholine, a major cause of cognitive impairment, is associated with BPSD, and that choline alphoscerate alone or combination with acetylcholine esterase inhibitors showed an enhancing effect on cholinergic neurotransmission, thereby reducing BPSD. In this study, the effects of donepezil monotherapy and donepezil and choline alphoscerate combination therapy on behavioral psychological symptoms of Alzheimer's disease were compared.
Methods: This study was conducted as a prospective, randomized, open-label study for 12 weeks. Among those who visited the Department of Psychiatry and Dementia Clinic at Inje University Ilsan Paik Hospital, 128 people aged 60 years or older who met the diagnostic criteria for 'neurocognitive impairment caused by Alzheimer's disease' defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). According to randomization, 64 patients were administered donepezil and 64 patients were administered donepezil and choline alphoscerate for 12 weeks. The Korean neuropsychiatric inventory (K-NPI), Geriatric depression scale was evaluated at baseline, week 4 and week 12, and the Mini-Mental Status Examination (MMSE), Global Deterioration Scale (GDS), and Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) scale were evaluated at baseline and week 12. Those who met the following conditions were excluded from the subjects - those diagnosed with dementia caused by other causes other than AD, those with a history of head trauma or brain injury, those with other neurodegenerative diseases (Parkinson's disease, Huntington's disease, etc.), patients with a history of drug abuse or other medical problems that may impair cognitive function, and patients with concomitant psychotic or mood disorders. The t-test was used for statistical analysis between the two groups, and the chi-square test was used for categorical variables. R version 4.3.1 (R Foundation for Statistical Computing, Vienna, Austria) was used. This study was approved by the IRB committee and conducted.
Result: This analysis included 41 donepezil administered patients (mean age 82.2 years, 34.1% male) and 42 donepezil and choline alphoscerate combined administered patients (mean age = 80.3 years, 45.2% male), and there was no statistically significant difference in age and education level in the two groups.
In each group, there was no statistically significant differences in MMSE K, GDS, Geriatric Depression Scale, Global NPI severity and frequency, caregiver distress, and NPI sub-items between baseline and 12 weeks. In the cognitive domain, there was no statistically significant difference between the two groups in each sub-item of ADAS-Cog at baseline and week 12.
Patients assigned to receive donepezil and alphoscerate, as compared with those assigned to receive donepezil, showed no significant improvement in the global NPI severity and frequency and the caregiver distress, the sub-items of NPI, geriatric depression scale, MMSE, GDS, ADAS-Cog scores after 12 weeks of treatment.
Conclusion: There was no significant difference in the improvement of behavioral psychological symptoms between donepezil and choline alphoscerate combination therapy and donepezil monotherapy. In addition, there was no difference between the two groups in improving cognitive function. Large-scale clinical studies on Alzheimer's disease patients are needed to verify the effectiveness of choline alphoscerate combination therapy in the future.