UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of surrogate markers and cognitive reserve related to Alzheimer's disease
Title of the study (Brief title)	Multimodal Neuroimaging for AD with Biomarker (MULNIAD-B)
Region	Japan

Condition
Condition	Healthy volunteer Alzheimer's disease (AD) Mild cognitive impairment (MCI)
Classification by specialty	Neurology Geriatrics Psychiatry Radiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objectives of this study that uses PET, MEG and MRI/fMRI are; 1) to visualize the "cognitive reserve" which influences the progression of Alzheimer's disease (AD),and 2) to establish surrogate markers for AD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visualization of cognitive reserve Detection of surrogate markers for AD
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy young volunteer 2) Cognitively Normal elderly (CN) 3) Intermediate between CN and MCI 4) Mild cognitive impairment (MCI) 5) Alzheimer's disease (AD) * 1): aged over 20 and less than 50 yrs. 2)-5): aged between 50 and 90 yrs.
Key exclusion criteria	Any significant neurological or psychiatric disease other than dementia Any significant disease such as cancer and heart disease Psychiatric symptoms
Target sample size	200

Research contact person
Name of lead principal investigator	Akinori Nakamura
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Clinical and Experimental Neuroimaging
Address	7-430, Morioka, Obu, Aichi, Japan
TEL	0562-46-2311
Email	nakamura@ncgg.go.jp

Public contact
Name of contact person	Akinori Nakamura
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Clinical and Experimental Neuroimaging
Address	7-430, Morioka, Obu, Aichi, Japan
TEL	0562-46-2311
Homepage URL
Email	nakamura@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	国立長寿医療研究センター

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 08 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 11 Month 26 Day
Anticipated trial start date	2014 Year 11 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	Nakamura A, et al. Early functional network alterations in asymptomatic elders at risk for Alzheimer's disease. Scientific reports. 2017;7(1):6517. Nakamura A, et al. Electromagnetic signatures of the preclinical and prodromal stages of Alzheimer's disease. Brain. 2018;141(5):1470-1485.
Other related information	Prospective Cohort Study This is an extension study of the prior projects UMIN000006419 merged with UMIN000012629. The study takes over all of the datasets from these prior projects.

Management information
Registered date	2015 Year 01 Month 07 Day
Last modified on	2018 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018720