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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022319
Receipt No. 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

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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
Email 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
Email kasaita@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025717

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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