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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004895
Receipt No. R000005831
Scientific Title Measurement of plasma beta-amyloid levels after glucose loading as diagnostic biomarker for Alzheimer disease
Date of disclosure of the study information 2011/01/18
Last modified on 2012/08/22

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Basic information
Public title Measurement of plasma beta-amyloid levels after glucose loading as diagnostic biomarker for Alzheimer disease
Acronym Measurement of plasma beta-amyloid levels after glucose loading as diagnostic biomarker for Alzheimer disease
Scientific Title Measurement of plasma beta-amyloid levels after glucose loading as diagnostic biomarker for Alzheimer disease
Scientific Title:Acronym Measurement of plasma beta-amyloid levels after glucose loading as diagnostic biomarker for Alzheimer disease
Region
Japan

Condition
Condition Alzheimer's disease
Classification by specialty
Medicine in general Neurology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Alzheimer disease (AD) is a progressive neurodegenerative disorder. Diagnosis of AD is required for development of therapy for the disease. However, non-invasive and easy method is not available. In this study, we will validate the availability of measurement of plasma Abeta levels after glucose loading.
Basic objectives2 Others
Basic objectives -Others Validation as a diagnostic marker
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Plasma beta amyloid levels after glucose loading
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria AD:
Diagnosed as probable AD National
Institute of Neurological and
Communicative Disorders and
Strokes-Alzheimers Disease and
Related Disorders Association
(NINCDS-ADRDA)
MMSE: less than 23
MRI: no other abnormality than atrophy
Key exclusion criteria Patients with diabetes mellitus
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoyuki Sato
Organization Osaka University, graduate school of medicine
Division name Department of clinical gene therapyDepartment of geriatric medicine
Zip code
Address 2-2, Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-3406
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoyuki Sato
Organization Osaka University
Division name Department of clinical gene therapyDepartment of geriatric medicine
Zip code
Address 2-2, Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-3406
Homepage URL http://www.cgt.med.osaka-u.ac.jp/
Email nsato@cgt.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 阪和第二泉北病院(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 18 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 Enrolling by invitation
Date of protocol fixation
2010 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We monitor plasma Abeta levels during 75g
OGTT.

Management information
Registered date
2011 Year 01 Month 18 Day
Last modified on
2012 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005831

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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