UMIN-CTR Clinical Trial

Basic information
Public title	Japanese Alzheimer's Disease Neuroimaging Initiative
Acronym	J-ADNI
Scientific Title	Japanese Alzheimer's Disease Neuroimaging Initiative
Scientific Title:Acronym	J-ADNI
Region	Japan

Condition
Condition	Alzheimer's disease, mild cognitive impairment (MCI)
Classification by specialty	Neurology Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To optimize the criteria for evaluation of treatments for Alzheimer's disease (AD), determination of surrogate biomarkers that reflect the pathophysiology of AD is mandatory. J-ADNI study aims at setting the standard values for long-term changes in imaging surrogate markers (e.g., MRI and PET), and simultaneously collecting clinical/neuropsychological data as well as blood/cerebrospinal fluid samples, to eventually prove the adequacy of the surrogate endpoints.
Basic objectives2	Others
Basic objectives -Others	Establishment of imaging and biochemical surrogate markers that reflect the progression of Alzheimer's disease.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical/neuropsychological examinations: CDR, MMSEm WMS-R logical memory I & II, ADAS-Cog, clock drawing/copying, symbol, block design, digit span, knowledge, fluency, trail making test A & B, Boston naming test, geriatric depression scale, Neuropsychiatric Inventory Q, FUnctional activity questionnaire Magnetic Resonance Imaging of brain: 1.5 tesla MRI in all cases, 3 tesla in 25% of cases Positron Emission Tomogram: fluorodeoxy glucose PET in 50% of cases Lumbar puncture: in 50% cases at baseline and 12 months blood and urine collection in all cases amyloid PET imaging (25% cases)
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	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	600

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Iwatsubo
Organization	School of Medicine, University of Tokyo
Division name	Department of Neuropathology
Zip code	113-0033
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 Takeshi Middle name Last name Iwatsubo
Organization	administration office of J-ADNI
Division name	office of clinical study administration
Zip code	113-0033
Address	7-3-1 Hongo Bunkyoku Tokyo
TEL	03-5841-3541
Homepage URL	http://www-j-adni.org/
Email	iwatsubo@m.u-tokyo.ac.jp

Sponsor
Institute	J-ADNI study group
Institute
Department

Funding Source
Organization	NEDO translational research funding
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Research association for Biotechnology
Name of secondary funder(s)	Ministry of Health, Labor and Welfare

IRB Contact (For public release)
Organization	Ethics Committee, School of Medicine, The University of Tokyo
Address	7-3-1 Hongo Bunkyoku Tokyo
Tel	03-5841-3311
Email	liaison@m.u-tokyo.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

Other administrative information
Date of disclosure of the study information	2008 Year 10 Month 01 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	No longer recruiting
Date of protocol fixation	2008 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date	2008 Year 09 Month 01 Day
Last follow-up date	2015 Year 09 Month 01 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, 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	2008 Year 09 Month 13 Day
Last modified on	2021 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001668