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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021596
Receipt No. R000024900
Scientific Title 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
Date of disclosure of the study information 2016/03/25
Last modified on 2019/05/13

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Basic information
Public title 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
Acronym Noto Rosmarinic Acid Project for Prevention of Dementia
Scientific Title 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
Scientific Title:Acronym Noto Rosmarinic Acid Project for Prevention of Dementia
Region
Japan

Condition
Condition subjective cognitive impairment and mild cognitive impairment
Classification by specialty
Neurology Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Evaluate the efficacy of Melissa officinalis extract which contained rosmarinic acid in older adults with subjective cognitive impairment and mild cognitive impairment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes The changes of ADAS-cog scores between baseline and 48-week/ 96-week after intake of rosmarinic acid
Key secondary outcomes (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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 (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
Interventions/Control_2 (1) To take placebo (10 capsules) per day for 96 weeks
(2) To stop placebo administration at 96th week of the test
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria 1. Age between 65-79 years old at informed consent
2. Residents in Nanao-city, Japan and its environs
3. Subjects fulfilled the diagnostic criteria of subjective cognitive impairment and mild cognitive impairment
4. MMSE score 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
Key exclusion 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)
Target sample size 330

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahito Yamada
Organization Kanazawa university Graduate School of Medical Science
Division name Department of Neurology and Neurobiology of Aging
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa, 920-8641, Japan
TEL 076-254-2290
Email m-yamada@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Moeko Shinohara
Organization Kanazawa university Graduate School of Medical Science
Division name Department of Neurology and Neurobiology of Aging
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa, 920-8641, Japan
TEL 076-265-2292
Homepage URL
Email m-nohara@med.kanazawa-u.ac.jp

Sponsor
Institute Department of Neurology and Neurobiology of Aging, Kanazawa university Graduate School of Medical Science
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Takasaki University of Health and welfare
Tokyo University Graduate School of Agricaltural and Life Sciences
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2016 Year 02 Month 24 Day
Date of IRB
2016 Year 03 Month 04 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The information of the clinical trial has been migrated to another database.

Management information
Registered date
2016 Year 03 Month 24 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024900

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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