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 control trial
- Conditions
- subjective cognitive impairment and mild cognitive impairment
- Registration Number
- JPRN-UMIN000021596
- Lead Sponsor
- Department of Neurology and Neurobiology of Aging, Kanazawa university Graduate School of Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 330
Not provided
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 more than 6 points at 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. The researcher determines that there is a medically significant risk 4. Subjects who has malignancy within 5 years before screening period. Except for the low risk of recurrence cases who has no recurrence for 3 years. The researcher must determine whether to exclude the subjects with malignancy 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 the researcher Table1. Prohibited concomitant therapy (Prohibition period) Cholinesterase inhibitors and glutamate NMDA receptor antagonist (3 months) Daily administration of anticholinergic drugs (4 weeks) Antidepressant drugs (4 weeks) Antipsychotic drugs (4 weeks) Mood-stabilizing drugs and anticonvulsants (4 weeks) Daily administration of hypnotic, sedative/benzodiazepines (4 weeks) Daily administration of narcotic analgesics (4 weeks) Anti-Parkinson's disease treatment drugs (3 months)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The changes of ADAS-cog scores between baseline and 48-week/ 96-week after intake of rosmarinic acid
- Secondary Outcome Measures
Name Time Method