Frailty Improvement by Multicomponent Drug, Ninjin'Yoeito, in Mild Cognitive Impairment and Mild Alzheimer's Disease Patients: An Open-Label Exploratory Study (FRAMINGO).

Background: Alzheimer's disease (AD) and dementia have increasingly been conceived of as "complex diseases of aging", determined by multiple, simultaneous, interacting pathophysiological processes. The condition known as frailty is a phenotype of aging and its comprehensive pathophysiology is thought to be closely related to the incidence of mild cognitive impairment (MCI) and the exacerbation of dementia. Objective: This study aimed to investigate the effect of the multicomponent drug, ninjin'yoeito (NYT), on frailty in MCI and mild AD patients. Methods: This study was an open-label trial. A total of 14 patients, including 9 with MCI and 5 with mild AD, were enrolled. Among them, 11 were frail while 3 were prefrail. NYT (6-9 g/day) was administered orally for 24 weeks, and assessments were carried out at baseline (week 0), and at 4, 8, 16, and 24 weeks. Results: In the primary endpoint, significant early improvements were observed in the anorexia scores according to the Neuropsychiatric Inventory after four weeks of treatment with NYT. The Cardiovascular Health Study score was significantly improved, and no frailty was observed after 24 weeks. The fatigue visual analog scale scores also significantly improved. The Clinical Dementia Rating and the Montreal Cognitive Assessment scores remained at baseline levels during the NYT treatment period. Conclusion: The results suggest that NYT may be effective in the treatment of frailty, especially for anorexia and fatigue, in both MCI and mild AD patients, which would be beneficial for the prognosis of dementia.

Application of the 18-Item Dementia Elderly Odayaka Scale in Japan: Evaluation before and after Intervention.

INTRODUCTION: We have developed the Dementia Elderly Odayaka Scale (DEOS) to evaluate psychosocial aspects in older people. The DEOS can be used to assess well-being, such as personhood and social interaction. OBJECTIVE: The aim of this study was to apply the 18-item DEOS in participants with dementia and to examine the characteristics and usefulness of this scale. METHODS: Facility staff provided care for the participants while taking into consideration each participant's individuality and strong points. The DEOS was applied at the beginning of the interventions and at 1 and 2 months after the start of the interventions. The changes in the participants' behaviors and their DEOS scores were then evaluated over time. RESULTS: We examined 13 participants (2 men, 11 women) between the ages of 68 and 91 years. In 60% of the participants the DEOS score increased over time. When care interventions were tailored toward communication and leadership for the 2 men, according to each of their individualities, we observed increases in their scores for "social interaction" at 1 and 2 months thereafter. We also observed increases in the scores for "Expression of emotions" category in 2 of the 5 cases who received an aromatherapy massage. DISCUSSION/CONCLUSION: The changes in the scores over time and the contents of the field notes were consistent with each other, suggesting that the DEOS can be used both to evaluate the effects of interventions and to plan care that takes advantage of each participant's positive aspects.

A Possibility of Simultaneous Treatment with the Multicomponent Drug, Ninjin'yoeito, for Anorexia, Apathy, and Cognitive Dysfunction in Frail Alzheimer's Disease Patients: An Open-Label Pilot Study.

A recent classification analysis of neuropsychiatric symptoms in patients with Alzheimer's disease (AD) revealed a distinct cluster with apathy and eating problems including anorexia that exhibits frailty. The apathy and frailty are risk factors in the disease progresses. However, there is currently no effective drug for treating both anorexia and apathy in AD. Here, we conducted an open-label pilot study to determine whether ninjin'yoeito (NYT, TJ-108), a multicomponent drug, is effective for improving anorexia and apathy in patients with AD, and consequently their cognitive function. Trials were conducted at three sites in Japan. Twenty patients [4 men and 16 women, average age = 82.6±7.7 (mean±SD) years old], including 19 AD and 1 mixed dementia with anorexia/apathy, were examined. NYT (6-9 g/day) was administered for 12 weeks. The changes in scores for "anorexia" using the Neuropsychiatric Inventory (NPI) subcategory for eating disturbance (primary outcome measure), NPI including "apathy", the vitality index, Mini-Mental State Examination (MMSE), and physical and blood nutrition indices were evaluated at baseline (week 0), and weeks 4, 8 and 12. After week 4, significant improvements were observed in the scores for "anorexia" and "apathy" by NPI and meal ingestion amount. Vitality index and MMSE score were significantly improved by week 12. We propose that NYT, a multicomponent drug with several effects including dopamine modulation, is a new-type dementia therapeutic agent with low risk of adverse reactions that can improve simultaneously anorexia/apathy, as well as cognitive dysfunction in frail AD patients.