Alzheimer'
Conditions
Interventions
Actural drug group 1)To take 200mg (4capsules) rosmarinic acid per day for 2 weeks after the start of the test. 2)To take 400mg (8capsules) rosmarinic acid per day for 2nd-4th weeks. 3)To take 500m
Sponsors
Kanazawa University Graduate School of Medical Science
Takasaki University of Health and welfare Tokyo University Graduate School of Agricaltural and Life Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Alzheimer's disease outpatients older than 60 years old at informed consent. 2.Patients with probable AD dementia with evidence of the AD pathophysiological process (Biomarker probability of AD etiology High) according to the criteria of National Institute on Aging-Alzheimer's Association workgroups (NIA-AA). 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 alchol 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 60 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 |
|---|---|
| To evaluate safety and tolerability of long-term intake of rosmarinic acid. Including incidence of adverse event, physical examination, neurological examination, vital signs, laboratory examination and cognitive tests. The ratio of the patients who completed the course of rosmarinic acid intake (200mg-500mg per day) for 48 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the changes of cognitive tests between screening and post-intake of rosmarinic acid. 1: Significant improvement, 2: Improvement, 3: No change, 4: Slight deterioration, 5: Deterioration, 6: Can not be determined. To evaluate the changes of PIB-PET, FDG-PET, cerebrospinal fluid biomarkers (Abeta1-42, total tau protein, phosphorylated tau protein) between screening and 24th week of the study. | — |
Countries
Japan
Contacts
Public ContactKenjiro Ono, Moeko Shinohara
Kanazawa University Graduate School of Medical Science Department of Neurology and Neurobiology of Aging
Outcome results
None listed