NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000019573

Registered date:02/11/2015

18F flutemetamol amyloid-beta PET imaging compared with 11CPIB across the spectrum of Alzheimer's disease

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedAlzheimer's disease
Date of first enrollment2011/11/28
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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. 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

Outcome(s)

Primary OutcomeThe 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.
Secondary OutcomeCortical 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

Key inclusion & exclusion criteria

Age minimum40years-old
Age maximum90years-old
GenderMale and Female
Include criteria
Exclude criteriaAD 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.

Related Information

Contact

public contact
Name Sizuo Hatashita
Address Nurumizu118-1 Atsugi-City,Kanagawa,Japan Japan
Telephone 046-297-7576
E-mail tiken2@shonan-atsugi.jp
Affiliation Shonan-Atsugi hospital Department of neurosurgery
scientific contact
Name Sizuo Hatashita
Address Nurumizu118-1 Atsugi-City,Kanagawa,Japan Japan
Telephone 046-223-3636
E-mail tiken2@shonan-atsugi.jp
Affiliation Shonan-Atsugi hospital Department of neurosurgery