An exploratory study of ninjin'yoeito on anorexia in frail mild cognitive impaiement/ mild Alzhemer's disease patients (FRAMINGO study)
Not Applicable
- Conditions
- Mild cognitive impairment, mild Alzheimer-type dementia or mild mixed dementiadementia, Alzheimer's disease, Alzheimer-type dementia, mild cognitive impairment, frailty, anorexia, apathy, fatigue
- Registration Number
- JPRN-jRCTs071190011
- Lead Sponsor
- Ishida Yasushi
- Brief Summary
The present results suggest that ninjinyoeito may be effective in the treatment of frailty, especially anorexia and fatigue, in both MCI and mild AD patients, which might be beneficial for the prognosis of dementia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 14
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anorexia at 24 weeks after administration compared to baseline
- Secondary Outcome Measures
Name Time Method 1. Fatigue<br>2. Apathy<br>3. Cognitive function<br>4. Cerebral blood flow<br>5. Frailty