UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on diagnosis of Alzheimer disease by amyloid imaging: A multi-center trial
Title of the study (Brief title)	A PET study of amyloid imaging in Alzheimer disease
Region	Japan

Condition
Condition	Healthy normal volunteers, Mild cognitive impairment (MCI), Alzheimer disease (AD)
Classification by specialty	Geriatrics Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Alzheimer's disease (AD) is the common cause of dementia in the elderly. Currently, clinical diagnosis of AD is based on clinical criteria that require the presence of memory impairment and at least one of several other cognitive dysfunctions. Although these criteria have been well accepted, detection of AD patients in early, or at least mild, stage of the disease is still problematic. Previous neuropathological studies have suggested that substantial deposition of diffuse plaques is considered to be the initial pathological change in AD that precedes cognitive deterioration. Thus, molecular positron emission tomography (PET) imaging that can detect diffuse plaques in vivo may be ideal for pre-symptomatic detection of AD patients. The purpose of this multi-center trial is to compare the PET imaging using [11C]BF-227 and [18F]FDG, magnetic resonance imaging (MRI), and psychological cognitive tests among healthy volunteers, mild cognitive impairment, and AD patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	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.
Key secondary outcomes	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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	35 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Criteria for Normal volunteers: Normal Volunteers are examined by FDG-PET, [11C]BF-227-PET, MRI and psychological tests. Male and female volunteers aged more than 35 years old are recruited for this study. They should understand the purpose and rationale of this study. 2)Criteria for Alzheimer disease: Alzheimer patients diagnosed as a probable AD according to NINCDS-ADRDA are enrolled. MMSE (Mini-mental state examination) is over 18, and apparent cognitive dysfunction is present in the patients. Informed consents are obtained from patients family and possibly from patients themselves. 3)Criteria for Mild Cognitive Impairment 1.Amnestic MCI. 2.No apparent neurological and psychiatric disorders. 3.There are no neurological symptoms. 4.There are no psychiatric symptoms. 5.The patients do not show dementia.
Key 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.
Target sample size	80

Research contact person
Name of lead principal investigator	Professor Kazuhiko Yanai
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Pharmacology
Address	Seiryo-machi 2-1, Aoba-Ku, Sendai 980-8575, Japan
TEL	022-717-8055
Email

Public contact
Name of contact person	Dr. Nobuyuki Okamura
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Pharmacology
Address	Seiryo-machi 2-1, Aoba-Ku, Sendai 980-8575, Japan
TEL	022-717-8058
Homepage URL	http://www.pharmacology.med.tohoku.ac.jp/
Email	yanai@med.tohoku.ac.jp

Sponsor
Institute	Study Group on diagnosis of Alzheimer disease by amyloid imaging using [11C]BF-227
Institute
Department

Funding Source
Organization	A Grant-in Aid for Research on nano-medicine from the Ministry of Health and Welfare, Japan (2006-2008)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	1)Department of Geriatrics and Gerontology, Tohoku University School of medicine 2)Cyclotron and Radioisotope Center, Tohoku University
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	東北大学大学院医学系研究科 東京都健康長寿医療センター研究所 国立長寿医療センター

Other administrative information
Date of disclosure of the study information	2007 Year 01 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 10 Month 01 Day
Anticipated trial start date	2006 Year 10 Month 01 Day
Last follow-up date	2012 Year 03 Month 01 Day
Date of closure to data entry	2012 Year 03 Month 01 Day
Date trial data considered complete	2012 Year 03 Month 01 Day
Date analysis concluded	2012 Year 12 Month 01 Day

Related information
URL releasing protocol	http://www.pharmacology.med.tohoku.ac.jp/
Publication of results	Partially published
URL releasing results
Results	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.
Other related information	The repeated measurement of [11C]BF227 would be possible during the study periods. Other PET facilities interested in amyloid imaging would be able to participate in this study.

Management information
Registered date	2006 Year 12 Month 25 Day
Last modified on	2017 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000000676