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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010991
Receipt No. R000012764
Scientific Title Japanese Alzheimer's Disease Neuroimaging Initiative, Second Stage
Date of disclosure of the study information 2013/06/18
Last modified on 2015/12/18

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Basic information
Public title Japanese Alzheimer's Disease Neuroimaging Initiative, Second Stage
Acronym J-ADNI2
Scientific Title Japanese Alzheimer's Disease Neuroimaging Initiative, Second Stage
Scientific Title:Acronym J-ADNI2
Region
Japan

Condition
Condition mild cognitive impairment, preclinical Alzheimer disease
Classification by specialty
Neurology Geriatrics Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the progression of AD pathology at these very early stages, biomarkers (including neuroimaging) are mandatory. We have conducted Japanese AD Neuroimaging Initiative (J-ADNI) since 2007, achieving brain morphometry using MRI, functional imaging by PET, biomarker assessment in body fluids, studies on AD-related genes, and clinical/neuropsychological assessments in a longitudinal multisite clinical studies. We were able to predict conversion from MCI to AD dementia using amyloid signatures, and detect changes in neuroimaging prior to the onset of AD dementia, setting the bases for assessments in clinical trials for DMT. In the J-ADNI2 stage, we aim at focusing on early MCI and preclinical AD, in addition to late MCI we studied in J-ADNI1, describe the natural course of these prodromal stages of AD through observational studies, to diagnose individuals who have high risks for developing dementia.
Basic objectives2 Others
Basic objectives -Others Towards the successful development of disease-modifying therapies (DMTs) for Alzheimer disease (AD), therapeutic intervention at the mild cognitive impairment (MCI) stage preceding AD dementia, and at the preclinical AD stage with AD pathology but without symptomatic manifestations, is required. J-ADNI2 study contributes to this goal.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes (1) preclinical AD study: progression rate to CDR 0.5 (MCI) stage in amyloid PET positive or negative groups
(2) MCI study: progression rate (conversion) to dementia in amyloid PET positive or negative groups
Key secondary outcomes Rate of change in MRI brain morphometry, uptake in FDG-PET in amyloid PET positive or negative groups, cognitive tests, and their correlation with cerebrospinal fluid biomarkers and apoE genotype

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
84 years-old >=
Gender Male and Female
Key inclusion criteria 1. Preclinical AD study: 150 amyloid PET-positive and 150 amyloid PET-negative cognitively normal individuals, whose language is Japanese. In addition, participants in J-ADNI1 as cognitively normal, who had completed 3-year longitudinal study and were amyloid PET-positive or low CSF Abeta(1-42) (n=~20), will be asked about their willingness to further participate in J-ADNI2.
2. MCI study: 100 late MCI and 100 early MCI individuals who meet with the criteria of each type of MCI (below).In addition, participants in J-ADNI1 as (late) MCI, who had completed 3-year longitudinal study and were amyloid PET-positive or low CSF Abeta(1-42) (n=~20), will be asked about their willingness to further participate in J-ADNI2.
3. Living at home, accompanied by a study partner who has a direct contact with the participant >10 hr per week. The participant should be accompanied by the study partner at every visit throughout the study.
4.The participants and study partners should sign agreement forms.
5. Age: 65-84 years (preclinical AD study) and 60-84 years (MCI study) upon enrollment. Individuals of both sexes will be enrolled.
6a. Criteria for participants in preclinical AD study
MMSE: 24-30
Scores of Wechsler memory Scale-R logical memory II (corrected for education), above the cut-off levels.
education 0-7 years: 3 or above
8-15 years: 5 or above
>16 years 9 or above
CDR 0, not depressed
Individuals who are amyloid PET-positive upon screen scan are categorized as "preclinical AD" and amyloid PET-negative as "normal aged".
6b. Criteria for amnestic MCI
Memory disturbance approved by the participant or study partner or clinician.
MMSE: 24-30
Scores of Wechsler memory Scale-R logical memory II (corrected for education), below the cut-off levels.
education 0-7 years: 2 or lower (late MCI); 3-6 (early MCI)
10-15 years: 4 or lower (late MCI); 5-9 (early MCI)
>16 years 8 or lower (late MCI); 9-11 (early MCI)
CDR 0.5 not depressed
Key exclusion criteria 1. Parkinson' disease, Lewy body dementia, frontotemporal dementia, Huntington's disease, progressive supranuclear palsy or other neurodegenerative diseases other than AD. Multiple cerebral infarction, normal pressure hydrocephalus, brain tumor, epilepsy, subdural hematoma, multiple sclerosis, head trauma with sequelae will also be excluded.
2. Signs of brain infection, focal brain lesions (eg infarction) that may affect cognitive function. Individuals with subcortical small infarction or diffuse white matter lesions can be included except for those in specific lesions affecting cognition. Cortical infarcts are normally excluded.
3. Presence of pacemaker, arterial clip, artificial valves, artificial cochlea, and other magnetic/electroconductive metals in the body that may affect MRI scan.
4. Major depression or bipolar disorder within past 1 year, past history of schizophrenia, defined by DSM-IV.
5. Addiction to alcohol or other drugs within past 2 years.
6. Past history of psychiatric symptoms, agitation or abnormal behaviors that affect protocol adherence within past 3 months.
7. Presence of fatal or unstable diseases.
8. Vitamin B12 or folate deficiency, syphilis, thyroid function abnormality.
9. Admission to care home or hospitals.
10. Administration of specific drugs (defined in J-ADNI2 procedure manual) including psychoactive drugs and warfarin.
11. Administration of any drugs in clinical trial within 1 month prior to screening.
12. Participation in clinical studies or clinical trials other than J-ADNI.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Iwatsubo
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Neuropathology and University Hospital
Zip code
Address 7-3-1 Hongo Bunkyoku Tokyo
TEL 03-5841-3541
Email iwatsubo@m.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Iwatsubo
Organization Data Center of J-ADNI
Division name Clinical Research Support Center, The University of Tokyo
Zip code
Address 7-3-1 Hongo Bunkyoku Tokyo
TEL 03-5841-3541
Homepage URL
Email iwatsubo@m.u-tokyo.ac.jp

Sponsor
Institute J-ADNI2 study group
Institute
Department

Funding Source
Organization NEDO, The Ministry of Health and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Research Association for Biotechnology
Name of secondary funder(s) Ministry of Economy, Trade and Industry; public funding from the pharmaceutical industry consortium at the Research Association for Biotechnology

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 東京大学医学部附属病院をはじめとする全国41施設

Other administrative information
Date of disclosure of the study information
2013 Year 06 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 Terminated
Date of protocol fixation
2013 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 24 Day
Last follow-up date
2018 Year 03 Month 31 Day
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, 12,24,36 M (preclinical AD study), baseline, 6,12,24,36M (MCI study) . MRI (at every visit) and amyloid PET scan (at screening/baseline and 36M) will be performed in all cases.

Management information
Registered date
2013 Year 06 Month 18 Day
Last modified on
2015 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012764

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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