UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019573 |
|---|---|
| Receipt number | R000022627 |
| Scientific Title | 18F flutemetamol amyloid-beta PET imaging compared with 11CPIB across the spectrum of Alzheimer's disease |
| Date of disclosure of the study information | 2015/11/02 |
| Last modified on | 2017/01/10 11:00:14 |
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Basic information
Public title
18F flutemetamol amyloid-beta PET imaging compared with 11CPIB across the spectrum of Alzheimer's disease
Acronym
18F flutemetamol and 11CPIB PET imaging across Alzheimer's disease
Scientific Title
18F flutemetamol amyloid-beta PET imaging compared with 11CPIB across the spectrum of Alzheimer's disease
Scientific Title:Acronym
18F flutemetamol and 11CPIB PET imaging across Alzheimer's disease
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology | Psychiatry | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim was to identify the amyloid beta AB deposition by PET imaging with18Flabeled PIB derivative 18F flutemetamol FMM across a spectrum of Alzheimer's disease AD, and compared AB deposition between 18F FMM and 11CPIB PET imaging.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cortical FMM SUVR in AD patients was significantly greater than in older HC subjects 1.76 +- 0.23 vs 1.30 +- 0.26, p<0.01. Six-eight MCI patients had a bimodal distribution of SUVR, and 29 of them 42.6% had positive scans. Cortical FMM SUVR values were strongly correlated with PIB DVR r=0.94, n=145, p<0.001.
Key secondary outcomes
Cortical FMM SUVR was negatively correlated with MMSE scores r= -0.51, n=145, p<0.05 and positively with CDR SB scores r=0.49, n=145, p<0.05 when all groups were analyzed together.
There was no significant difference in the mean cortical FMM SUVR between APOE 4 carriers and non-carriers in each group
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
11CPIB was injected intravenously as a bolus with a mean dose of 551.5 +- 39.7 MBq. Dynamic PET scanning in the three dimensional mode was performed for 60 min using a predetermined protocol of 31 frames as follows: 4 x 15s, 8 x 30s,
9 x 60s,2 x 120s, and 8 x 300s.
Interventions/Control_2
A single dose of 18 FFMM of 197.0 +- 5.9 MBq was injected as a bolus. The image acquisition window of 18F FMM extended from 85 to 115 minutes 6 x5 min. frames.
The retention of 18F FMM was calculated as the regional to cerebellum standardized uptake value ratios SUVR. Standardized uptake values, defined as the decay corrected brain radioactivity concentration, were normalized for the injected dose and body weight. The regional FMM SUVR in each cortical region
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
AD subjects were older than 56 years, and met the core clinical criteria of the NIA Alzheimer's Association for probable AD.
MCI subjects were older than 56 years, and met the Core Clinical Criteria for MCI proposed by the NIA Alzheimer's Association.
The normal cognitive status of HC subjects was required to be a MMSE score of 28 or greater and a CDR score of 0.
All subjects or their caregiver provided written informed consent for participation.
Key exclusion criteria
AD subjects were older than 56 years, and met the core clinical criteria of the NIA-Alzheimer's Association for probable AD.
MCI subjects were older than 56 years, and met the Core Clinical Criteria for MCI proposed by the NIA-Alzheimer's Association.
The normal cognitive status of HC subjects was required to be a MMSE score of 28 or greater and a CDR score of 0.
All subjects or their caregiver provided written informed consent for participation.
Participants were excluded if they had other systemic or brain diseases,including degenerative,vascular, depressive, traumatic, medical comorbidities, mixed disease, or traumatic brain injury.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sizuo Hatashita |
Organization
Shonan-Atsugi hospital
Division name
Department of neurosurgery
Zip code
Address
Nurumizu118-1 Atsugi-City,Kanagawa,Japan
TEL
046-223-3636
tiken2@shonan-atsugi.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sizuo Hatashita |
Organization
Shonan-Atsugi hospital
Division name
Department of neurosurgery
Zip code
Address
Nurumizu118-1 Atsugi-City,Kanagawa,Japan
TEL
046-297-7576
Homepage URL
tiken2@shonan-atsugi.jp
Sponsor or person
Institute
Shonan-Atsugi hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan-Atsugi hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 11 | Month | 02 | 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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 30 | Day |
Last modified on
| 2017 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022627
