UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024351
Receipt number R000028040
Scientific Title Efficacy of acupuncture to treat mild cognitive impairment : a randomized controlled trial.
Date of disclosure of the study information 2016/10/12
Last modified on 2017/06/22 13:16:24

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Basic information

Public title

Efficacy of acupuncture to treat mild cognitive impairment : a randomized controlled trial.

Acronym

Efficacy of acupuncture to treat mild cognitive impairment : a randomized controlled trial.

Scientific Title

Efficacy of acupuncture to treat mild cognitive impairment : a randomized controlled trial.

Scientific Title:Acronym

Efficacy of acupuncture to treat mild cognitive impairment : a randomized controlled trial.

Region

Japan


Condition

Condition

mild cognitive impairment

Classification by specialty

Neurology Geriatrics Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This single center randomized controlled trial aims to investigate the efficacy of acupuncture treat MCI.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

MCI screening test
Blood protein of pre-3-month therapy and post-3-month therapy:APOA1,TTR,C3.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Acupuncture therapy and brain training game/twice a week/three month.

Interventions/Control_2

Brain training game/twice a week/three month.

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

age:65 and over.
assessment:MPI score 49.8 fewer.

Key exclusion criteria

Presenting dimentia or other disease-associated cognitive impairment.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name MASATO EGAWA

Organization

Meiji University of Integrative Medicine

Division name

Department of Health Promoting and Geriatric Acupuncture and Moxibustion

Zip code


Address

Hiyoshi-cho Nantan-shi Kyoto-hu

TEL

090-1144-5360

Email

m_egawa@meiji-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name TAKAYUKI TAKEOKA

Organization

Meiji University of Integrative Medicine

Division name

Promoting and Geriatric Acupuncture and Moxibustion

Zip code


Address

Hiyoshi-cho Nantan-shi Kyoto-hu

TEL

080-6098-4500

Homepage URL


Email

t_takeoka@meiji-u.ac.jp


Sponsor or person

Institute

Meiji University of Integrative Medicine

Institute

Department

Personal name



Funding Source

Organization

Meiji University of Integrative Medicine

Organization

Division

Category of Funding Organization

Other

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

2016 Year 10 Month 12 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

2016 Year 10 Month 10 Day

Date of IRB


Anticipated trial start date

2016 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 10 Month 11 Day

Last modified on

2017 Year 06 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028040


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name