UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017936 |
|---|---|
| Receipt number | 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 11:39:59 |
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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
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
miura@njs.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020792
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
