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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000034297
Receipt No. R000039101
Scientific Title Data analyses and biomarkers measurements of J-ADNI
Date of disclosure of the study information 2018/09/27
Last modified on 2018/09/27

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Basic information
Public title Data analyses and biomarkers measurements of J-ADNI
Acronym Data analyses and biomarkers measurements of J-ADNI
Scientific Title Data analyses and biomarkers measurements of J-ADNI
Scientific Title:Acronym Data analyses and biomarkers measurements of J-ADNI
Region
Japan

Condition
Condition Alzheimer's disease
Mild cognitive impairment
Classification by specialty
Neurology Geriatrics Psychiatry
Radiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purposes are pathophysiological investigation and early diagnosis of Alzheimer's disease using open data of J-ADNI ((Japanese Alzheimer's bDisease Neuroimaging Initiative), which were multi-center cohort study of Alzheimer's disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To find and validate imaging and biomarker predictors for converting from MCI to AD dementia.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
84 years-old >=
Gender Male and Female
Key inclusion criteria 150 cases of normal aged individuals, 300 cases of MCI, 150 cases of early AD, whose language is Japanese.
Living at home, accompanied by a study partner.
The participants should sign agreement forms. In case the participant is not capable of agreeing, the study partner should sign in substitution.
Age: 60-84 years upon enrollment

Criteria for normal aged individuals
MMSE: 24-30
Scores of Wechsler memory Scale-R logical memory II (corrected for education), above the cut-off levels.
education 0-9 years: 3 or above
10-15 years: 5 or above
>16 years 9 or above

Criteria for amnestic MCI
Type 1: complaint of memory disturbance from the participant plus approval by the study partner
Type 2: memory disturbance approved by the study partner, without the subjective complaint of the participant
(excluded in case only with subjective memory complaint, without approval by the study partner)
MMSE: 24-30
Scores of Wechsler memory Scale-R logical memory II (corrected for education), below the cut-off levels.
education 0-9 years: 2 or lower
10-15 years: 4 or lower
>16 years 8 or lower
CDR 0.5 not depressed

Criteria for early AD
MMSE: 20-26
Scores of Wechsler memory Scale-R logical memory II (corrected for education), below the cut-off levels.
education 0-9 years: 2 or lower
10-15 years: 4 or lower
>16 years 8 or lower
CDR 0.5 or 1
Probable AD by the criteria of NINCDS-ADRDA
(Causes or diseases leading to dementia other than AD excluded)
Key exclusion criteria 1. Parkinson' disease, multiple cerebral infarction, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, head trauma with sequelae
2. Signs of brain infection, focal brain lesions (eg infarction) that may affect cognitive function.
3. Presence of pacemaker, arterial clip, artificial valves, artificial cochlea, and other magnetic/electroconductive metals in the body that may affect MRI
4. Major depression or bipolar disorder within past 1 year, addiction to alcohol or other drugs within past 2 years, presence of fatal or unstable diseases, vitamin B12 or folate deficiency, syphilis, thyroid function abnormality
5. administration of psychoactive drugs (defined in procedure manual)
6. administration of warfarin
Target sample size 0

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kato
Organization National Center for Geriatrics and Gerontology
Division name Department of Radiology
Zip code
Address 7-430, Morioka, Obu, Aichi, Japan
TEL 0562-46-2311
Email tkato@ncgg.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kato
Organization National Center for Geriatrics and Gerontology
Division name Department of Radiology
Zip code
Address 7-430, Morioka, Obu, Aichi, Japan
TEL 0562-46-2311
Homepage URL https://humandbs.biosciencedbc.jp/hum0043-v1
Email tkato@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization The Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Other
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
2018 Year 09 Month 27 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 Terminated
Date of protocol fixation
2016 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Clinical/neuropsychological evaluation, neuroimaging work-ups and collection of biofluid samples are undertaken longitudinally at baseline, 6,12,24,36 M (normal individuals), baseline, 6,12,18,24,36M (MCI) and baseline, 6, 12, 24 M (early AD).

Management information
Registered date
2018 Year 09 Month 27 Day
Last modified on
2018 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039101

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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