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

JRCT ID: jRCTs071190011

Registered date:26/06/2019

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
• 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

Related Information

• Primary Sponsor: Ishida Yasushi
• Source(s) of Monetary Support: Tsumura & Co.