UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030430 |
|---|---|
| Receipt number | R000034744 |
| Scientific Title | The longitudinal study of relationship between changes in cognitive function and beta amyloid accumulation in the brain using 11C-Pib PET |
| Date of disclosure of the study information | 2017/12/18 |
| Last modified on | 2019/10/01 15:25:40 |
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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
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
takebou@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034744
