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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025008
Receipt No. R000028773
Scientific Title Development of CSF/plasma biomarker which can predict onset of Alzheimer's disease
Date of disclosure of the study information 2016/12/12
Last modified on 2016/11/27

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Basic information
Public title Development of CSF/plasma biomarker which can predict onset of Alzheimer's disease
Acronym Development of Alzheimer's disease biomarker
Scientific Title Development of CSF/plasma biomarker which can predict onset of Alzheimer's disease
Scientific Title:Acronym Development of Alzheimer's disease biomarker
Region
Japan

Condition
Condition Alzheimer's disease
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In AD brain, Abeta42 peptide is accumulated. Due to the accumulation, its value in CSF is rather lowered in the patients. We discovered some Abeta like peptides which are produced by BACE and gamma-secretase just like Abeta. By measuring the levels of these peptides in CSF/plasma, we can estimate Abeta production or degradation in brain.
Basic objectives2 Others
Basic objectives -Others Development of AD onset prediction marker
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We investigate how the value or the ratio of Abeta like peptides change in CSF or plasma of AD, MCI, or preclinical AD patients.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 AD or MCI patients in neuropsychiatry department in Osaka University are recruited. They undergo cognition tests including MMSE and CSF and/or blood sampling.
Interventions/Control_2 Non-AD patients in neuropsychiatry department in Osaka University are recruited. They undergo cognition tests including MMSE and CSF and/or blood sampling.
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
30 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients who are clinically diagnosed as Alzheimer`s Disease, MCI, or non-AD.
Key exclusion criteria not particular
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayasu Okochi
Organization Osaka University Graduate School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address D3 2-2 Yamadaoka Suita, Osaka Japan
TEL 06-6879-3051
Email mokochi@psy.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayasu Okochi
Organization Osaka University Graduate School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address D3 2-2 Yamadaoka Suita, Osaka Japan
TEL 06-6879-3051
Homepage URL
Email mokochi@psy.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Japanese Education Ministry
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor J-ADNI
Osaka University Mental Health Promotion
Higashi Matsudo Hospital
Dept. of Mol. Genetics, Brain Res. Institute, Niigata Univ
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 07176-6
Org. issuing International ID_1 Osaka University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪大学医学部附属病院 神経科精神科

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/20049724
Number of participants that the trial has enrolled
Results
Surrogate markers for the Alzheimer disease (AD)-associated 42-amino acid form of amyloid-beta (Abeta42) have been sought because they may aid in the diagnosis of AD and for clarification of disease pathogenesis. Here, we demonstrate that human cerebrospinal fluid (CSF) contains three APLP1-derived Abeta-like peptides (APL1beta) that are generated by beta- and gamma-cleavages at a concentration of approximately 4.5 nM. These novel peptides, APL1beta25, APL1beta27 and APL1beta28, were not deposited in AD brains. Interestingly, most gamma-secretase modulators (GSMs) and familial AD-associated presenilin1 mutants that up-regulate the relative production of Abeta42 cause a parallel increase in the production of APL1beta28 in cultured cells. Moreover, in CSF from patients with pathological mutations in presenilin1 gene, the relative APL1beta28 levels are higher than in non-AD controls, while the relative Abeta42 levels are unchanged or lower. Most strikingly, the relative APL1beta28 levels are higher in CSF from sporadic AD patients (regardless of whether they are at mild cognitive impairment or AD stage), than those of non-AD controls. Based on these results, we propose the relative level of APL1beta28 in the CSF as a candidate surrogate marker for the relative level of Abeta42 production in the brain.
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 Open public recruiting
Date of protocol fixation
2008 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 27 Day
Last modified on
2016 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028773

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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