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

Phase 1
Completed
Conditions
Mild Cognitive Impairment, Alzheimer disease
Registration Number
JPRN-jRCT1091220187
Lead Sponsor
Hokuriku National Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
MMSE, WMS-R
Secondary Outcome Measures
NameTimeMethod
MRI, FDG-PET, PIB-PET
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