UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000558 |
|---|---|
| Receipt number | R000000676 |
| Scientific Title | Study on diagnosis of Alzheimer disease by amyloid imaging: A multi-center trial |
| Date of disclosure of the study information | 2007/01/10 |
| Last modified on | 2017/07/03 11:35:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on diagnosis of Alzheimer disease by amyloid imaging: A multi-center trial
Acronym
A PET study of amyloid imaging in Alzheimer disease
Scientific Title
Study on diagnosis of Alzheimer disease by amyloid imaging: A multi-center trial
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Professor Kazuhiko Yanai |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Pharmacology
Zip code
Address
Seiryo-machi 2-1, Aoba-Ku, Sendai 980-8575, Japan
TEL
022-717-8055
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dr. Nobuyuki Okamura |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Pharmacology
Zip code
Address
Seiryo-machi 2-1, Aoba-Ku, Sendai 980-8575, Japan
TEL
022-717-8058
Homepage URL
http://www.pharmacology.med.tohoku.ac.jp/
yanai@med.tohoku.ac.jp
Sponsor or person
Institute
Study Group on diagnosis of Alzheimer disease by amyloid imaging using [11C]BF-227
Institute
Department
Personal name
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)
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
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 |
Related information
URL releasing protocol
http://www.pharmacology.med.tohoku.ac.jp/
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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
| 2006 | Year | 10 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000676
