UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of clearance of amyloid beta from the brain by IVIg
Title of the study (Brief title)	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	Takahiko Tokuda
Organization	Kyoto Prefectural University of Medicine
Division name	Neurology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL	0752515794
Email	ttokuda@koto.kpu-m.ac.jp

Public contact
Name of contact person	Takashi Kasai
Organization	Kyoto Prefectural University of Medicine
Division name	Neurology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 06 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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