UMIN-CTR Clinical Trial

Basic information
Public title	Clinical investigation of ninjin'yoeito for psychiatric symptoms and physical frailty among patients with mild cognitive impairment and Alzheimer's disease.
Acronym	Effect of ninjin'yoeito among patients with mild cognitive impairment and Alzheimer's disease.
Scientific Title	Clinical investigation of ninjin'yoeito for psychiatric symptoms and physical frailty among patients with mild cognitive impairment and Alzheimer's disease.
Scientific Title:Acronym	Effect of ninjin'yoeito among patients with mild cognitive impairment and Alzheimer's disease.
Region	Japan

Condition
Condition	mild cognitive impairment or Alzheimer's disease
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the efficacy of ninjinyoeito on psychiatric symptoms and physical frailty in patients with mild cognitive impairment and early to moderate Alzheiemr's disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Psychiatric symptoms: the Neuropsychiatric Inventory at 12 weeks
Key secondary outcomes	12 weeks 1) Weight (Body mass index) 2) Nutritional status: Mini Nutritional Assessment-short form 3) Appetite: Simplified Nutritional Appetite Questionnaire 4) Physical performance: grip strength, timed Up and Go test 5) Body composition: Bioelectrical impedance analysis 6) Physical activities: International Physical Activity Questionnaire short version 7) Cognitive function: Mini Mental State Examination 8) Vitality: Vitality Index 9) Depressive mood: 15-Geriatric depression scale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Kracie Ninjinyoeito Extract Granules, 7.5g per day, 12 weeks
Interventions/Control_2	No treatment
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	89 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients who suffer from weakness, exhaustion, and/or anorexia. 2) Patients with apathy. 3) Patients who were diagnosed with mild cognitive impairment or early to moderate Alzheimer's disease based on the criteria of the NIA-AA. 4) Patients who have MMSE score of 11 points or more. 5) Patients who can walk without assistance. 6) Patients who have provided consent for participation by each subject and a family or caregiver. 7) Patients who can receive cooperation from family or caregiver.
Key exclusion criteria	1) Patients who have been taken other kampo medicines in the past month. 2) Patients who have MMSE score of 10 points or less. 3) Patients who switched or newly started using anti-dementia medications within 3 months from the start of the survey. 4) Patients who have been taking sweetroot-containing drug and/or glycyrrhizinate-containing drug. 5) Patients who switched or newly started using antipsychotic medications within 3 months from the start of the survey. 6) Patients who have mental disorders caused by cerebrovascular disorders, head injuries, brain tumors, or encephalitis. 7) Patients whom investigators consider to be ineligible.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Sakurai
Organization	National Center Geriatrics and Gerontology
Division name	Center for Comprehensive Care and Research on Memory Disorders
Zip code	474-8511
Address	7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL	0562-46-2311
Email	tsakurai@ncgg.go.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Sakurai
Organization	National Center Geriatrics and Gerontology
Division name	Center for Comprehensive Care and Research on Memory Disorders
Zip code	474-8511
Address	7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL	0562-46-2311
Homepage URL
Email	tsakurai@ncgg.go.jp

Sponsor
Institute	National Center Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	Kracie & CO.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research and Medical Division
Address	7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
Tel	0562-46-2311
Email	yaday@ncgg.go.jp

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	2018 Year 11 Month 28 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	10
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 12 Month 13 Day
Date of IRB	2017 Year 12 Month 13 Day
Anticipated trial start date	2018 Year 04 Month 17 Day
Last follow-up date	2018 Year 09 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 28 Day
Last modified on	2019 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039958