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

An open-label exploratory study of efficacy and safety of ninjin'yoeito on anorexia in frail patients with mild cognitive impairment or mild Alzhemer's disease (FRAMINGO study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs071190011

Enrollment

Registered

2019-06-26

Start date

2019-08-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild cognitive impairment, mild Alzheimer-type dementia or mild mixed dementia dementia, Alzheimers disease, Alzheimer-type dementia, mild cognitive impairment, frailty, anorexia, apathy, fatigue

Interventions

Ninjin'yoeito administered three times daily (3.0 g each, 9.0 g/ day) during the 24-week treatment period

Ninjin'yoeito, Kampo medicine, traditional Japanese medicine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Anorexia at 24 weeks after administration compared to baseline	—

Secondary

Measure	Time frame
1. Fatigue 2. Apathy 3. Cognitive function 4. Cerebral blood flow 5. Frailty	—

Contacts

Public ContactYasushi Ishida

University of Miyazaki Hospital

ishiday@med.miyazaki-u.ac.jp+81-985-85-2969

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026