UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002345 |
|---|---|
| Receipt number | R000002876 |
| Scientific Title | A randomised trial to assess the effect of Sea-alpa for the patients with mild cognitive impairment (MCI). |
| Date of disclosure of the study information | 2009/08/18 |
| Last modified on | 2013/03/19 11:43:40 |
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Basic information
Public title
A randomised trial to assess the effect of Sea-alpa for the patients with mild cognitive impairment (MCI).
Acronym
An interventional trial for MCI using Sea-alpa.
Scientific Title
A randomised trial to assess the effect of Sea-alpa for the patients with mild cognitive impairment (MCI).
Scientific Title:Acronym
An interventional trial for MCI using Sea-alpa.
Region
| Japan |
Condition
Condition
mild cognitive impairment
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether Sea-alpa is superior to its placebo in prevention of cognitive decline among patients with MCI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score in Japanese version of ADAS-Cog and Mini Mental State Examination.
Key secondary outcomes
Scores in Japanese version of ADCS-ADL, Geriatric Depression Scale.
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 considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The patients of active drug group will be intervened with 6 tablets of Sea-alpa every-day for 1 year.
Interventions/Control_2
The patients with placebo group will be intervened with 6 tablets of placebo every-day for 1 year.
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Outpatients with MCI of the department of Neuropsychiatry, University hospital of Tsukuba.
2) Being able to give a written informed consent to the participation in the present study.
3) Being able to observe the following requirements: good compliance with Sea-alpa; participation in the schedules examinations for assessment; keeping log-diary recording consumption of Sea-alpa.
4) Having a modified Hachinski Ischemic score of 4 or less.
5) Having the 15-item Geriatric Depression Scale score of 6 or less.
Key exclusion criteria
1) Meeting DSM-IV TR criteria for dementing illnesses.
2) Having serious or unstable illnesses.
3) Having a history within past 5 years of serious infections disease affecting the brain and/or malignant diseases.
4) Having a history of alcohol or drug abuse or dependence (on DSM-IVTR) within the past 5 years.
5) Receiving any types of anti-Alzheimer drugs.
6) Recent (within 4 weeks) initiation of medications that affect the central nervous system.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Asada |
Organization
University of Tsukuba
Division name
Department of Neuropsychiatry, Institute of Clinical Medicine
Zip code
Address
1-1-1, Tennodai, Tsukuba City, Ibaraki-prefecture
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Asada |
Organization
University of Tsukuba
Division name
Department of Neuropsychiatry, Institute of Clinical Medicine
Zip code
Address
1-1-1, Tennodai, Tsukuba City, Ibaraki-prefecture
TEL
Homepage URL
tasada@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Institute of Clinical Medicine University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Department of Neuropsychiatry, Institute of Clinical Medicine University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2009 | Year | 08 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 17 | Day |
Last modified on
| 2013 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002876
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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