UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017936
Receipt No. R000020792
Scientific Title The intervention study of the effects exerted by the electro-acupuncture stimulation of the upper limbs and lower limbs against cognitive decline · BPSD in early onset Alzheimer-type dementia
Date of disclosure of the study information 2015/07/01
Last modified on 2019/12/20 (Ver. 6)

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Basic information
Public title The intervention study of the effects exerted by the electro-acupuncture stimulation of the upper limbs and lower limbs against cognitive decline · BPSD in early onset Alzheimer-type dementia
Acronym The intervention study of the effects exerted by the electro-acupuncture stimulation of the upper limbs and lower limbs against cognitive decline · BPSD in early onset Alzheimer-type dementia
Scientific Title The intervention study of the effects exerted by the electro-acupuncture stimulation of the upper limbs and lower limbs against cognitive decline · BPSD in early onset Alzheimer-type dementia
Scientific Title:Acronym The intervention study of the effects exerted by the electro-acupuncture stimulation of the upper limbs and lower limbs against cognitive decline · BPSD in early onset Alzheimer-type dementia
Region
Japan

Condition
Condition Early onset Alzheimer-type dementia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether or not the cognitive function and BPSD improvement of the patient's early onset Alzheimer's type dementia is seen
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change before and after treatment of MMSE
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 In addition to the standard treatment in the intervention period (two months), to perform the electro-acupuncture treatment.
Interventions/Control_2
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
40 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1. At the time of obtaining informed consent, age is less than 65 years of age or 40 years old patient
2. Has a memory impairment, aphasia, apraxia, agnosia, one or more of the cognitive impairment of the executive dysfunction
3. Outpatient
4. After receiving a sufficient explanation Upon participation in this study, on the understanding, a person who has obtained the consent in writing from the person or egally authorized representative
Key exclusion criteria 1. Person who has caused cognitive dysfunction by cerebrovascular disease, central nervous system diseases such as Parkinson's disease
2. Person who has caused the cognitive dysfunction by systemic diseases such as hypothyroidism and folic acid deficiency
3. Person who has caused cognitive dysfunction due to substance-induced disease
4. Patients with metal allergy
5. Patients with the possibility of pregnant women and pregnancy or the patient during breast-feeding
6. Patients principal investigator has determined to be inappropriate as a subject
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Ozawa
Organization Nagasaki University Hospital
Division name Department of Neuropsychiatry
Zip code
Address 1-7-1 Sakamoto,Nagasaki
TEL 095-819-7293
Email ozawa07@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Miura
Organization Nagasaki University Hospital
Division name Department of Neuropsychiatry
Zip code
Address 1-7-1 Sakamoto,Nagasaki
TEL 095-819-7293
Homepage URL
Email miura@njs.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 07 Month 01 Day

Related information
URL releasing protocol none
Publication of results Unpublished

Result
URL related to results and publications none
Number of participants that the trial has enrolled 0
Results 
Canceled due to difficulty in securing subjects
Results date posted
2019 Year 12 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Canceled due to difficulty in securing subjects
Participant flow 
Canceled due to difficulty in securing subjects
Adverse events 
Not applicable
Outcome measures 
Not applicable
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2015 Year 06 Month 01 Day
Date of IRB
2015 Year 05 Month 25 Day
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
2017 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 08 Month 22 Day

Other
Other related information

Management information
Registered date
2015 Year 06 Month 17 Day
Last modified on
2019 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020792