JPRN-jRCT1091220187CompletedPhase 1
Efficacy and safety of ferulic acid and Angelica archangelica extrac in patients with mild cognitive impairment (MCI): Double blind placebo-controlled study - FAMCIS
Hokuriku National Hospital0 sites20 target enrollmentStarted: July 15, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 60age old to ot applicable (—)
- Sex
- All
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.
Investigators
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