UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027186 |
|---|---|
| Receipt number | 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 09:38:50 |
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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
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
shin_tanaka39@hotmail.com
Sponsor or person
Institute
Specified medical corporation, Rakuzankai, Mishima-hosipital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031153
