Effect of supplement involved ferulic acid, glycerophosphocholine and ginkgo leaf extract on mild cognitive impairment. -A randomized, double-blind, placebo-controlled, parallel-group clinical trial
- Conditions
- Mild Cognitive impairment
- Registration Number
- JPRN-UMIN000020894
- Lead Sponsor
- FANCL Corporation Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- o longer recruiting
- Sex
- All
- Target Recruitment
- 60
1 Subjects with MCI and who meet the following criteria
Amnestic MCI
CDR 0 or 0.5
MMSE 22-26 and/or ADAS-jcog 5-15
2 Subjects who giving written informed consent
1) Subjects who use or plan to use go drugs affecting cognitive function or dementia.
2) Subjects who constantly use Kampo preparation affecting cognitive function or dementia.
3) Subjects who constantly use functional supplement affecting cognitive function or dementia.
4) Subjects who have psychiatric disorder (schizophrenia, mania, depression, severe cardiopathy, delirium, alcoholism etc.) affecting cognitive function or dementia with the exception of complete remission.
5) Subjects who take medical treatment for psychoneurosis (confusion, hallucination, delusion, abnormal behavior etc.) with antipsychotic drug.
6) Subjects with metabolic disease (hypothyroidism, deficiency of vitamin B12, etc.) affecting cognitive function or dementia.
7) Subjects with liver disease, renal disease or hypoactivity of renal function (eGFR<=20 mL/min).
8) Subjects with type 2 diabetes and HbA1c>8.4%, insulin treatment or taking drug for insulin secretion accelerating agent.
9) Subjects with chronic obstructive lung disease (COPD) and oxygen therapy in home or FEV1<30%.
10) Subjects with essential hypertension or uncontrolled hyperlipidemia.
11) Subjects who have medical history of gastrointestinal surgery or hospitalization for head injury within 10 years.
12) Subjects who have history of intracerebral hemorrhage, subarachnoid hemorrhage, cardiac hypertrophy?cardiac failure, ischemic heart disease(IHD), nephrosclerosis, aortic dissection, cerebral infarction.
13) Subjects who take medical treatment for cancer.
14) Subjects who are planned to participate in other clinical study.
15) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Gloval Impression<br>Criteria: Changes of cognitive impairment in comparison with before intervention. <br>1. Remarkable improvement of MCI<br>2. Improvement of MCI<br>3. No change <br>4. Hypofunction of cognitive<br>Term for evaluation: 3 months, 6 months
- Secondary Outcome Measures
Name Time Method ADAS-jcog(total, test), MMSE