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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002345
Receipt No. 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

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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
Email

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
Email tasada@md.tsukuba.ac.jp

Sponsor
Institute Department of Neuropsychiatry, Institute of Clinical Medicine University of Tsukuba
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002876

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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