UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022319 |
|---|---|
| Receipt number | R000025717 |
| Scientific Title | Investigation of clearance of amyloid beta from the brain by IVIg |
| Date of disclosure of the study information | 2016/09/08 |
| Last modified on | 2016/09/06 19:41:34 |
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Basic information
Public title
Investigation of clearance of amyloid beta from the brain by IVIg
Acronym
Investigation of clearance of Abeta from the brain by IVIg
Scientific Title
Investigation of clearance of amyloid beta from the brain by IVIg
Scientific Title:Acronym
Investigation of clearance of Abeta from the brain by IVIg
Region
| Japan |
Condition
Condition
Alzheimer disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Direct measurement of clearance of amyloid beta protein from the brain by IVIg.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
levels of amyloid beta in plasma from juglar vein and from peripheral vein.
levels of amyloid beta in cerebrospinal fluid
Mini Mental State Examination
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous immunogloblin therapy
0.4g/kg/day x 3 days 3 cycles
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with mild cognitive impairment due to AD (Minimental state examination <28) or Patients with probable AD
Key exclusion criteria
Women of childbearing potential
Presence of pacemakers, or foreign metal objects in the body
Prior treatment experimental immunotherapeutics or vaccines for AD
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiko Tokuda |
Organization
Kyoto Prefectural University of Medicine
Division name
Neurology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
0752515794
ttokuda@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kasai |
Organization
Kyoto Prefectural University of Medicine
Division name
Neurology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
0752515794
Homepage URL
kasaita@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Blood Products Organization
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | Year | 09 | Month | 08 | 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
| 2008 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 16 | Day |
Last modified on
| 2016 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025717
