UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	18F flutemetamol amyloid-beta PET imaging compared with 11CPIB across the spectrum of Alzheimer's disease
Title of the study (Brief title)	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	Sizuo Hatashita
Organization	Shonan-Atsugi hospital
Division name	Department of neurosurgery
Address	Nurumizu118-1 Atsugi-City,Kanagawa,Japan
TEL	046-223-3636
Email	tiken2@shonan-atsugi.jp

Public contact
Name of contact person	Sizuo Hatashita
Organization	Shonan-Atsugi hospital
Division name	Department of neurosurgery
Address	Nurumizu118-1 Atsugi-City,Kanagawa,Japan
TEL	046-297-7576
Homepage URL
Email	tiken2@shonan-atsugi.jp

Sponsor
Institute	Shonan-Atsugi hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022627