Rosmarinic Acid Project for Prevention of Dementia

JRCT ID: jRCTs041180064

Registered date:04/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Subjective cognitive impairment and Mild cognitive impairment
• Date of first enrollment: 07/07/2016
• Target sample size: 350
• Study type: Interventional

Intervention(s)

1, Rosmarinic acid group
a) To take 500 mg (10 capsules) rosmarinic acid per day for 96 weeks.
b) To stop rosmarinic acid administration at 96th week of the test.
2. Placebo group
a) To take placebo (10 capsules) per day for 96 weeks,
b) 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 inhale 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 screening and 96 weeks after intake if 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 screening 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: >= 65age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

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.

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 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)

Related Information

• Primary Sponsor: Ono Kenjiro
• Secondary ID(s): UMIN00021596