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

UMIN ID: UMIN000021596

Registered date:25/03/2016

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: subjective cognitive impairment and mild cognitive impairment
• Date of first enrollment: 2016/07/01
• Target sample size: 330
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

(1) To take 500 mg (10 capsules) rosmarinic acid per day for 96weeks (2) To stop rosmarinic acid administration at 96th week of the test
(1) To take placebo (10 capsules) per day for 96 weeks (2) To stop placebo administration at 96th week of the test

Outcome(s)

• Primary Outcome: The changes of ADAS-cog scores between baseline and 48-week/ 96-week after intake of rosmarinic acid
• Secondary Outcome: (1) Comprehensive effects: The changes of CDR-SB scores between baseline and 48-week/ 96-week after intake of rosmarinic acid (2) Efficacy of prevention on the developing dementia: The incidence of dementia defined as Major neurocognitive disorder in DSM-5 (3) The total volume of the hippocampus: The changes of the total hippocampal volume quantified by MRI between baseline and 96-week after intake of rosmarinic acid (4) Activities of daily living: The changes of Barthel index and IADL scores between baseline and 48-week/ 96-week after intake of rosmarinic acid (5) Neuropsychological evaluation: The changes of MMSE scores between baseline and 48-week/ 96-week after intake of rosmarinic acid (6) Safety of rosmarinic acid: To evaluate safety of long-term intake of rosmarinic acid. Including incidence of adverse event, vital signs, laboratory examination, and head MRI. (7) The changes of biomarkers (blood amyloid-beta protein etc) and the association between biomarkers and cognition (ADAS-cog score etc) (8) Compliance rate: The differences of the results of Primary and Secondary outcomes for each compliance rate

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: 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)

Related Information

• Primary Sponsor: Department of Neurology and Neurobiology of Aging, Kanazawa university Graduate School of Medical Science
• Secondary Sponsor: Takasaki University of Health and welfare Tokyo University Graduate School of Agricaltural and Life Sciences
• Source(s) of Monetary Support: Japan Society for the Promotion of Science Japan Agency for Medical Research and Development