NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs071190011

Registered date:26/06/2019

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedMild cognitive impairment, mild Alzheimer-type dementia or mild mixed dementia
Date of first enrollment06/08/2019
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeAnorexia at 24 weeks after administration compared to baseline
Secondary Outcome1. Fatigue 2. Apathy 3. Cognitive function 4. Cerebral blood flow 5. Frailty

Key inclusion & exclusion criteria

Age minimum>= 55age old
Age maximumNot applicable
GenderBoth
Include criteria1. 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 criteria1. 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

Related Information

Contact

Public contact
Name Yasushi Ishida
Address 5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan Miyazaki Japan 889-1692
Telephone +81-985-85-2969
E-mail ishiday@med.miyazaki-u.ac.jp
Affiliation University of Miyazaki Hospital
Scientific contact
Name Yasushi Ishida
Address 5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan Miyazaki Japan 889-1692
Telephone +81-985-85-2969
E-mail ishiday@med.miyazaki-u.ac.jp
Affiliation University of Miyazaki Hospital