J Korean Geriatr Psychiatry.  2025 Oct;29(2):29-36. 10.47825/jkgp.2025.29.2.29.

The Effects of Combined Treatment With Choline Alfoscerate on Behavioral Psychological Symptoms in Patients With Alzheimer’s Disease Receiving a Acetylcholinesterase Inhibitors

• Kim H
• Lee KJ

• KMID: 2573887
• DOI: http://doi.org/10.47825/jkgp.2025.29.2.29

Abstract

Objective
This study aimed to compare the effects of donepezil monotherapy and combination therapy with donepezil and choline alfoscerate on behavioral and psychological symptoms and cognitive function in patients with Alzheimer’s disease.
Methods
A prospective, randomized, open-label study was conducted with 128 patients aged 60 years or older diagnosed with Alzheimer’s disease at Ilsan Paik Hospital from September 2022 to December 2024. Patients were assigned to the donepezil monotherapy group (n=41) or the donepezil plus choline alfoscerate group (n=42) for 12 weeks. The treatment effects were evaluated using the Mini-Mental State Examination–Korean version (MMSE-K), Global Deterioration Scale (GDS), Geriatric Depression Scale–Korean version (GDS-K), Korean Neuropsychiatric Inventory (K-NPI), and Alzheimer’s Disease Assessment Scale–Cognitive subscale (ADAS-Cog).
Results
After 12 weeks of treatment, neither group showed statistically significant improvement in the MMSE-K, GDS, and GDS-K scores compared with baseline. In both groups, no significant improvements were observed in the K-NPI total severity, frequency, caregiver distress scores, or any of the individual subdomain scores. The magnitude of change in these measures also did not differ significantly between the two groups. Similarly, in the ADAS-Cog, neither group demonstrated significant improvement from baseline in any subdomain, and there were no statistically significant differences in change scores between the groups. The results of the intention-to-treat analysis were consistent with those of the per-protocol analysis, showing no significant differ- ences between the two treatment groups.
Conclusion
In this study, combination therapy with donepezil and choline alfoscerate did not show a statistically significant improvement in behavioral and psychological symptoms or cognitive function compared with donepezil monotherapy. Further large-scale, long-term follow-up studies and subgroup analyses stratified by dementia subtype are warranted.

Keyword

Alzheimer’s disease; Donepezil; Choline alfoscerate; Behavioral psychological symptoms of dementia