Study on diagnosis of Alzheimer disease by amyloid imaging: A multi-center trial

Phase 1

• Conditions: Healthy normal volunteers, Mild cognitive impairment (MCI), Alzheimer disease (AD)

• Registration Number: JPRN-UMIN000000558
• Lead Sponsor: Study Group on diagnosis of Alzheimer disease by amyloid imaging using [11C]BF-227

Brief Summary

Initial PET studies using [11C]BF-227 have been started at Tohoku University and Tokyo Metropolitan Institute of Gerontology. The accumulation patterns of [11C]BF-227 in Alzheimer patients were different from those of normal volunteers. Increased brain areas were consistent with those rich with amyloid plaques. The half of MCI patients showed increased accumulation of [11C]BF227. We also compared PET amyloid imaging to FDG-PET, and the preliminary results suggested the superiority of amyloid imaging.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-10
• Study Completion: 2012-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

1)The past and present history of alcoholism. 2)The past and present history of epilepsy 3)Education period is less than 6 years. 4)There are no persons who can give any information on patients symptoms. 5)Diabetic patients treated with insulin 6)Patients treated with antidepressants, antipsychotics, and long-term sedative-hypnotics. 7)Severe complication including malignancy, heart failure, hepatic dysfunction, renal dysfunction, endocrine disorders, etc. 8)Other patients and volunteers that investigators and medical doctors need to exclude.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The molecular PET imaging using [11C]BF-227. The [11C]BF-227-PET is evaluated by cortical SUV ratios to cerebellum as a reference among healthy volunteers, mild cognitive impairment, and Alzheimer patients.

Secondary Outcome Measures

Name	Time	Method
The comparison of FDG-PET, MRI, psychological cognitive tests, and [11C]BF-227-PET among healthy volunteers, mild cognitive impairment, and Alzheimer patients. The [11C]BF-227-PET is evaluated by cortical SUV ratios to cerebellum as a reference