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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-

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- - A clinical trial to study the effect of ferulic acid on mild cognitive impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020894
Enrollment
60
Registered
2016-02-05
Start date
2016-02-05
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

Interventions

Test food:tablet(ferulic acid, glycerophosphocholine, ginkgo leaf extract) Administration period:180days Control food:tablet(not contained ferulic acid, glycerophosphocholine, ginkgo leaf extract) A

Sponsors

FANCL Corporation Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Clinical Gloval Impression Criteria: Changes of cognitive impairment in comparison with before intervention. 1. Remarkable improvement of MCI 2. Improvement of MCI 3. No change 4. Hypofunction of cognitive Term for evaluation: 3 months, 6 months

Secondary

MeasureTime frame
ADAS-jcog(total, test), MMSE

Countries

Japan

Contacts

Public ContactYuki Nishiura

Mebix, Inc. Research Promotion Head Office

ferulic-a@mebix.co.jp03-4362-4500

Outcome results

None listed

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