NIPH Clinical Trials Search

An exploratory study of ninjin'yoeito on anorexia in frail mild cognitive impaiement/ mild Alzhemer's disease patients (FRAMINGO study)

Basic Information

Recruitment status	Complete
Health condition(s) or Problem(s) studied	Mild cognitive impairment, mild Alzheimer-type dementia or mild mixed dementia
Date of first enrollment	06/08/2019
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	Ninjin'yoeito administered three times daily (3.0 g each, 9.0 g/ day) during the 24-week treatment period

Outcome(s)

Primary Outcome	Anorexia at 24 weeks after administration compared to baseline
Secondary Outcome	1. Fatigue 2. Apathy 3. Cognitive function 4. Cerebral blood flow 5. Frailty

Key inclusion & exclusion criteria

Age minimum	>= 55age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Patients with mild cognitive impairment, mild Alzheimer-type dementia or mild mixed dementia patients 2. Pre-frail or frail patients 3. Patients with an anorexia 4. Have a study partner able to provide an independent evaluation of functioning 5. Agreement to sign an informed consent
Exclude criteria	1. Severe agitation/aggression 2. Major depression, bipolar disorder, alcoholism, or drug addiction within the previous 2 years 3. Patients with a life-threatening disease such as malignant tumor