UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021596 |
|---|---|
| Receipt number | 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 08:22:52 |
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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
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
m-nohara@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Neurology and Neurobiology of Aging, Kanazawa university Graduate School of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024900
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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