UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035047
Receipt number R000039958
Scientific Title Clinical investigation of ninjin'yoeito for psychiatric symptoms and physical frailty among patients with mild cognitive impairment and Alzheimer's disease.
Date of disclosure of the study information 2018/11/28
Last modified on 2019/12/23 09:07:08

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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 or person

Institute

National Center Geriatrics and Gerontology

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039958


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name