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.

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.

[The Role of Psychiatric Clinics in Dementia Care].

On June 18, 2012, a project team for dementia care in the Ministry of Health, Labour and Welfare released a report on future approaches in medical care for dementia. Based on this report, the "5-year plan for promoting dementia measures ("Orange Plan")" was published on September 5. At the beginning of the report, they present an ideal society where patients can continue to live in the community after being diagnosed with dementia. I think this direction exactly shows "the Community-based Integrated Care". For this, the role of psychiatric clinics in the health care of people with dementia is to help avoid admission to psychiatric hospitals. Therefore, as psychiatrists, we must provide a diagnosis of dementia, drug therapy, and non-drug therapy for BPSD. Furthermore, in my clinic, I provide body management and the treatment of physical complications. Also, interprofessional work is essential for these things to be done effectively.