UMIN-CTR Clinical Trial

Basic information
Public title	The longitudinal study of relationship between changes in cognitive function and beta amyloid accumulation in the brain using 11C-Pib PET
Acronym	The study investigating cognitive decline and beta amyloid accumulation in the brain
Scientific Title	The longitudinal study of relationship between changes in cognitive function and beta amyloid accumulation in the brain using 11C-Pib PET
Scientific Title:Acronym	The study investigating cognitive decline and beta amyloid accumulation in the brain
Region	Japan

Condition
Condition	Alzheimer disease, mild cognitive decline, preclinical Alzheimer disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this study is to find the new detection of Alzheimer disease at the preclinical stage by combining assessment of beta amyloid accumulation in the brain, changes in cognitive function and functional neuroimaging technique.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	11C-PiB PET, FDG-PET and cognitive tests are performed every year and followed for three years. PiB PET shows accumulation of beta amyloid protein, and FDG PET reveals glucose metabolisms in the brain. As cognitive batteries, MMSE, FAB, MoCA-J and WMSR are performed.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	The radioactive agent of 11C-PiB (555MBq)is administered. PET scan is performed once a year for three years.
Interventions/Control_2	The radioactive agent of FDG (185MBq) is administered. PET scan is performed once a year for three years.
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	45 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Mild and moderate grade of Alzheimer disease (MMSE 18 - 23), mild cognitive decline patients (MMSE 24 - 26) are recruited. Normal cognitive subjects also participate in this study. They are classified into two groups; preclinical Alzheimer disease group (amyloid positive) and amyloid negative group at the initial 11C-PiB PET study.
Key exclusion criteria	Depression patients
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takenobu Middle name Last name Murakami
Organization	Fukushima Medical University
Division name	Neurology
Zip code	960-1295
Address	Hikarigaoka 1, Fukushima
TEL	024-547-1248
Email	takebou@fmu.ac.jp

Public contact
Name of contact person	1st name Takenobu Middle name Last name Murakami
Organization	Fukushima Medical University
Division name	Neurology
Zip code	9601295
Address	Hikarigaoka 1, Fukushima
TEL	024-547-1248
Homepage URL
Email	takebou@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	Fukushima Medical University
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Fukushima Medical University
Address	Hikarigaoka 1, Fukushima
Tel	024-547-1111
Email	rs@fmu.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	2017 Year 12 Month 18 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	37
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	Terminated
Date of protocol fixation	2017 Year 10 Month 06 Day
Date of IRB	2017 Year 10 Month 06 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2019 Year 02 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 16 Day
Last modified on	2019 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034744