Efficacy and safety of ferulic acid and Angelica archangelica extrac in patients with mild cognitive impairment (MCI): Double blind placebo-controlled study

Efficacy and safety of ferulic acid and Angelica archangelica extrac in patients with mild cognitive impairment (MCI): Double blind placebo-controlled study - FAMCIS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1091220187

Enrollment

Registered

2014-07-15

Start date

2014-07-11

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, Alzheimer disease

Interventions

Intervention type:DRUG Name of intervention:Treatment Dose form / Japanese Medical Device Nomenclature:CAPSULE Route of administration / Site of application:ORAL Dose per administration:120 120 mg Dos

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.MCI outpatients older than 60 years old at informed consent. 2.Patients with MCI who fulfilled the MCI criteria (Reisberg(1991); MayoClinic,Petersen(1995)). 3.MMSE score 20-26 points and CDR score 0.5 or 1. 4.Patient could be distinguished from other dementia disorders. 5.Patient can administrate the tablets and patient and patient's family can manage taking medicine. 6.Written informed consent of patient and patient's family.

Exclusion criteria

Exclusion criteria: 1.Patients taken supplements which contain polyphenols within 1 month. 2.Patients with severe heart disease, liver disease, kidney disease. 3.Patients who has malignancy. 4.Patients who has previous history of alcohol and/or drug abuse. 5.Patients who has hypersensitivity to polyphenols. 6.Patients who has drug and/or food allergy. 7.Patients participating in other clinical trials. 8.Patients newly administrated other dementia therapeutics within 30 days including Galantamine Hydromide (Reminyl, Takeda pharmaceutical company limited. Janssen pharmaceutica), Memantine Hydrochoride (Memary, DaiichiSankyo company limited), Rivastigmine (Exelon patch, Novartis/ Rivastach patch, Ono pharmaceutical company limited), Donepezil Hydrochloride (Aricept, Aricept D, Eisai). During this trial, addition and change of other dementia therapeutic drugs are not permitted in principle. 9.The patients judged to inadequacy by the attending physician or principal investigator.

Design outcomes

Primary

Measure	Time frame
MMSE, WMS-R	—

Secondary

Measure	Time frame
MRI, FDG-PET, PIB-PET	—

Countries

Japan

Contacts

Public ContactMitsuhiro Yoshita

Hokuriku National Hospital

yoshitam@hosp.go.jp+81-763-62-1340

Outcome results

None listed

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