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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027186
Receipt No. R000031153
Scientific Title Double blind comparative study of effects of amino acids in patient with cognitive dementia
Date of disclosure of the study information 2017/06/01
Last modified on 2019/03/28

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Basic information
Public title Double blind comparative study of effects of amino acids in patient with cognitive dementia
Acronym Evaluation of effects of amino acids in patient with dementia
Scientific Title Double blind comparative study of effects of amino acids in patient with cognitive dementia
Scientific Title:Acronym Evaluation of effects of amino acids in patient with dementia
Region
Japan

Condition
Condition dementia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Search the possibility of effects of amino acids in patient with dementia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes neuropsychiatric symptom
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Placebo
Interventions/Control_2 Amino Acids
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Mild Alzheimer's disease.
2)Patients with neuropsychiatric symptom.
3)Agreement available with proxy.
4)Antidementia drugs treatment over 4 weeks or no treatment of antidementia drugs.
Key exclusion criteria 1)Taking supplements in major components of amino acids, DHA, EPA and ginko leaf extract.
Taking Chinese medicine including YOKUKANSAN.
2)Less than 6 years of schooling history.
3)Alcholic poisoning or under treatment of it
4)Under treatment of cancer of cirrhosis.
5)Getting artificial dialysis.
6)Patients taking medicine for neuropsychiatric disorder, however, that this shall not apply when dose of these drugs are stable.
7)Soy allergy.
8)Patients that representative or sub investigator determine inappropriate.
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin Tanaka
Organization Specified medical corporation, Rakuzankai, Mishima-hosipital
Division name Psychiatry
Zip code
Address 1713-8, Fujikawa, Nagaoka-shi, Nigata-Prefecture, 940-2302
TEL 0258-42-2311
Email shin_tanaka39@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shin Tanaka
Organization Specified medical corporation, Rakuzankai, Mishima-hosipital
Division name Psychiatry
Zip code
Address 1713-8, Fujikawa, Nagaoka-shi, Nigata-Prefecture, 940-2302
TEL 0258-42-2311
Homepage URL
Email shin_tanaka39@hotmail.com

Sponsor
Institute Specified medical corporation, Rakuzankai, Mishima-hosipital
Institute
Department

Funding Source
Organization AJINOMOTO CO., INC.
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 06 Month 01 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 Completed
Date of protocol fixation
2017 Year 03 Month 06 Day
Date of IRB
2017 Year 01 Month 26 Day
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
2018 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 28 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031153

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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