UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004895 |
|---|---|
| Receipt number | 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 | 2023/04/27 20:48:01 |
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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 | Naoyuki |
| Middle name | |
| Last name | Sato |
Organization
Osaka University, graduate school of medicine
Division name
Department of clinical gene therapyDepartment of geriatric medicine
Zip code
565-0871
Address
2-2, Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-3406
nsato@cgt.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Sato |
Organization
Osaka University
Division name
Department of clinical gene therapyDepartment of geriatric medicine
Zip code
565-0871
Address
2-2, Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-3406
Homepage URL
http://www.cgt.med.osaka-u.ac.jp/
nsato@cgt.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Ethics Commitee
Address
2-15, Yamada-oka, Suita
Tel
06-6879-5685
rinri@hp-crc.med.osaka-u.ac.jp
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
https://www.karger.com/Article/Abstract/338704
Publication of results
Published
Result
URL related to results and publications
https://www.karger.com/Article/Abstract/338704
Number of participants that the trial has enrolled
21
Results
The plasma levels of baseline blood glucose, plasma insulin, and plasma Abeta were not different between the two groups. However, immediately after glucose loading, a significant increase in plasma Abeta40 and Abeta42 levels was observed in AD patients, whereas a mild decrease in plasma Abeta40 and Abeta42 levels was detected in non-AD dementia patients.
Results date posted
| 2023 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Ten AD and 11 non-AD dementia patients (4 with vascular dementia, 2 with frontotemporal dementia, 2 with normal pressure hydrocephalus, 1 with post-traumatic dementia, and 2 with other neurodegenerative dementia) admitted for dementia treatment and care participated in this study. Probable AD was diagnosed using the National Institute of Neurological and Communication Disorders and Stroke/Alzheimer Disease and Related Disorders Association criteria. Subjects were screened by medical history, neuropsychological examination, physical examination, EKG, and biochemical parameters, including liver and kidney function, nutritional status, and glucose level. None of the patients in this study clearly met the diagnostic standard for diabetes. In addition, none of the patients was receiving a cholinesterase inhibitor, oral blood glucose-lowering medication, or insulin treatment.
Participant flow
Informed consent was obtained from all patients, and written consent was obtained from the patient families. All study protocols were approved by the Osaka University Hospital Institutional Review Board and the Hanwa Daini Senboku Hospital Institutional Review Board. The patients fasted for 13 hours from dinner on the night before the trial, and the trial was started at 8:30 am the next day. After collection of a baseline venous blood sample (6 ml), 75 g glucose (225 ml) was administered orally. Subsequently, venous blood samples were collected at 15,30,60 and 120 min. Oral administration of glucose solution was completed within approximately 5 min, and no apparent problems arose with regard to glucose loading.
Adverse events
None
Outcome measures
Plasma Abeta40 and 42
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2010 | Year | 08 | Month | 31 | Day |
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
| 2023 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005831
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