Community-based study about the efficacy of Melissa officinalis extract which contained rosmarinic acid on cognitive function in older adults with subjective cognitive impairment and mild cognitive impairment: A double blind, placebo-controlled, parallel-design, randomized controlled trial - Rosmarinic Acid Project for Prevention of Dementia

Ono Kenjiro0 个研究点目标入组 350 人开始时间: 2019年3月4日最近更新: 2023年10月17日

试验速览

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•1, Age between 65-79 years old at informed consent.
•2, Residents in Kanazawa-city or Nano-city, Japan and those environs.
•3, subjects fulfilled the diagnostic criteria of subjective cognitive impairment and mild cognitive impairment.
•4, MMSE score is more than 24 points at screening test.
•5, Subjects have reading comprehension equivalent to the six grade of elementary school, and subjects without intellectual disabilities.
•6, Physical findings, vital signs, and laboratory examination at screening test are within normal limits or within the acceptable range.
•7, Subjects agree to provide a blood or urine to test laboratory examination and APOE genotype.
•8, Subjects can administrate the tablets and subject's family can manage taking medicine.
•9. Subjects agree not to change the lifestyle such as exercise and eating habits.

•1, Subjects who have mental illness such as schizophrenia, bipolar disorder, depression etc. based on the diagnostic criteria of DSM-5.
•2, GDS-15 score is more than 6 points at the screening test.
•3, Subjects with uncontrolled health problem such as diabetes mellitus, hypertension, heart failure, angina pectoris, renal dysfunction, etc. within 3 months before screening period. In case the researcher determines that there are medically significant risks.
•4, Subjects who has malignancy within 5 years before screening period except for the low risk of recurrence for 3 years.
•5, Subjects administrated the prohibited concomitant therapy within prohibition period shown in Table1(*).
•6, Subjects who has previous history of alcohol and/or drug abuse.
•7, Subjects who has hypersensitivity to polyphenols.
•8, Subjects who has drug and/or food allergy.
•9, The subjects judged to inadequacy by researchers.
•*Table 1. Prohibited concomitant therapy (prohibition period)
•a) Cholinesterase inhibitors and glutamate NMDA receptor antagonist (3 months)
•b) Daily administration of anticholinergic drugs (4 weeks)
•c) Antidepressant drugs (4 weeks)
•d) Antipsychotic drugs (4 weeks)
•e) Mood-stabilizing drugs and anticonvulsants (4 weeks)
•f) Daily administration of hypnotic, sedative/ benzodiazepines (4 weeks)
•g) Daily administration of narcotic analgesics (4 weeks)
•h) Anti-Parkinson's disease treatment drugs (3 months)

发起方

Ono Kenjiro