Efficacy and Safety of Tsumura Ninjin'yoeito for Loss of Appetite and Apathy in Patients With Alzheimer's Disease or Dementia With Lewy Bodies: A Multicentre, Open-Label, Randomised, Comparative Study.

📖 Top 30% JournalDec 4, 2025Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society

Ninjin'yoeito for Improving Appetite and Mood in Dementia Patients

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Abstract

A total of 49 patients participated, with 24 receiving Ninjin'yoeito (NYT) and 25 in the control group.

No significant difference in the primary outcome of appetite loss score change was observed between the NYT and control groups at 12 weeks.
Patients in the NYT group showed a significant increase in food intake at both 4 and 12 weeks compared to the control group.
Significant decreases in the Neuropsychiatric Inventory-12 total score, depression, apathy, and eating behavior were recorded in the NYT group at various time points, although these were not statistically different from the control group.
In a post hoc analysis, participants with a loss of appetite score of ≥ 6 in the NYT group exhibited significant decreases in appetite scores from baseline at 8 and 12 weeks compared to the control group.
These findings suggest a potential role for NYT in improving appetite in patients with Alzheimer's disease or dementia with Lewy Bodies.

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AIM: No effective agents currently exist for treating loss of appetite and apathy in patients with dementia. This multicentre, randomised, comparative study aimed to evaluate the effect and safety of Ninjin'yoeito (NYT) for these symptoms in patients with Alzheimer's disease (AD) or dementia with Lewy Bodies (DLB).

METHODS: A total of 16 sites, including clinics and hospitals, participated in this study. The primary outcome measure was the 12-week change in the loss of appetite score in the 'eating behaviour' subcategory of the Neuropsychiatric Inventory-12 (NPI-12). Secondary outcome measures included changes in food intake, the NPI-12 score, the Japanese Version of the Zarit Caregiver Burden Interview, Vitality Index, Mini-Mental State Examination, Frontal Assessment Battery, body weight, red blood cell count, haemoglobin, albumin, and Controlling Nutritional Status Score.

RESULTS: Regarding the efficacy evaluation, 24 and 25 patients were assigned to the NYT and control groups, respectively. Regarding the primary outcome-the change in the loss of appetite score-no significant difference was observed between the two groups at 12 weeks after the start of administration. Among the secondary outcomes, food intake showed a significant increase in the NYT group compared to the control group at both 4 and 12 weeks. In the NYT group, significant decreases were recorded in the NPI-12 total score at 4 and 8 weeks; in depression at 12 weeks; in apathy at 4, 8, and 12 weeks; and in eating behaviour at 4, 8, and 12 weeks. However, these changes were not different from those in the control group. In a post hoc subgroup analysis of participants with a loss of appetite score of ≥ 6, significant decreases from baseline at 8 and 12 weeks were observed in the NYT group compared to the control group.

CONCLUSIONS: Although the primary endpoint did not reach statistical significance, likely due to insufficient sample size, the NYT group showed a significant improvement in food intake, a secondary outcome measure. Furthermore, exploratory post hoc subgroup analysis suggested that NYT may improve appetite in patients with more severe appetite loss at baseline. These findings indicate the potential role of NYT in appetite improvement in patients with AD or DLB, warranting further investigation.