UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000001374
Receipt number	R000001668
Scientific Title	Japanese Alzheimer's Disease Neuroimaging Initiative
Date of disclosure of the study information	2008/10/01
Last modified on	2021/09/23 09:10:26

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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

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 or person

Institute

J-ADNI study group

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001668

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name