UMIN-CTR Clinical Trial

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

Alzheimer's disease
Mild cognitive impairment

Classification by specialty

Neurology	Geriatrics	Psychiatry
Radiology	Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

To find and validate imaging and biomarker predictors for converting from MCI to AD dementia.

Key secondary outcomes

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name

Organization

The Japan Agency for Medical Research and Development (AMED)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

09

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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).

Registered date

2018

Year

09

Month

27

Day

Last modified on

2018

Year

09

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039101