UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020576
Receipt number R000023713
Scientific Title Longitudinal Observational Cohort Study of Autosomal Dominant Alzheimer's Disease (ADAD) (DIAN-J)
Date of disclosure of the study information 2016/01/15
Last modified on 2020/07/20 14:29:35

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Basic information

Public title

Longitudinal Observational Cohort Study of Autosomal Dominant Alzheimer's Disease (ADAD) (DIAN-J)

Acronym

Longitudinal Observational Cohort Study of Autosomal Dominant Alzheimer's Disease (ADAD) (DIAN-J)

Scientific Title

Longitudinal Observational Cohort Study of Autosomal Dominant Alzheimer's Disease (ADAD) (DIAN-J)

Scientific Title:Acronym

Longitudinal Observational Cohort Study of Autosomal Dominant Alzheimer's Disease (ADAD) (DIAN-J)

Region

Japan


Condition

Condition

Autosomal Dominant Alzheimer disease (ADAD)

Classification by specialty

Neurology Geriatrics Psychiatry

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To study dominantly inherited AD in individuals for whom the diagnosis is certain (mutation carriers) in comparison with their non-carrier siblings, who serve as a naturally occurring control group.

Basic objectives2

Others

Basic objectives -Others

Observation

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

clinical, cognitive, genetic, imaging, and biomarker

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

;Written informed consent obtained from the participant and collateral source prior to any study-related rocedures.
;child of an affected individual(clinically or by testing) in a pedigree with a known mutation for ADAD.
;Participant is cognitively normal.
;Participant is a native speaker of Japanese and is fluent in Japanese communication.

Key exclusion criteria

;Participant has a medical or psychiatric illness that would interfere in completing initial and follow-up assessments.
;Participant has advanced cognitive impairment requiring nursing home-level care.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Shimada

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Diagnostic and Interventional Radiology

Zip code

545-8585

Address

1-4-3 Asahimachi, Abenoku, Osaka

TEL

06-6646-6185

Email

h.shimada@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Shimada

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Diagnostic and Interventional Radiology

Zip code

545-8585

Address

1-4-3 Asahimachi, Abenoku, Osaka

TEL

06-6646-6185

Homepage URL


Email

h.shimada@med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University Graduate school of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Osaka City University Graduate school of Medicine

Address

1-2-7 Asahimachi, Abenoku, Osaka

Tel

06-6645-3457

Email

ethics@med.osaka-cu.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

NCT00869817

Org. issuing International ID_1

Clinicaltrials.govA service of the U.S. National Institutes of Health

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

大阪市立大学医学部附属病院(大阪府)
新潟大学医歯学総合病院(新潟県)
東京大学医学部附属病院(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 15 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

Open public recruiting

Date of protocol fixation

2016 Year 01 Month 04 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Longitudinal Observational Cohort Study
All paricipants who visited the participating reseach facilities after February 1,2016 and met selection criteria.
clinical, cognitive, genetic, imaging, and biomarker


Management information

Registered date

2016 Year 01 Month 15 Day

Last modified on

2020 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023713


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name