UMIN-CTR Clinical Trial

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
Last 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
1st 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