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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001420
Receipt No. R000001733
Scientific Title Amyloid imaging study using positron emission tomography with [F-18]FACT for dementia
Date of disclosure of the study information 2008/11/01
Last modified on 2012/01/05

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Basic information
Public title Amyloid imaging study using positron emission tomography with [F-18]FACT for dementia
Acronym Amyloid imaging study for dementia
Scientific Title Amyloid imaging study using positron emission tomography with [F-18]FACT for dementia
Scientific Title:Acronym Amyloid imaging study for dementia
Region
Japan

Condition
Condition Dementia
Classification by specialty
Neurology Psychiatry Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate amyloid deposits in brain using positron emission tomography in Alzheimer's disease and mild cognitive impairment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison between patients and age- and gender-matched normal controls regarding follows:
- Amyloid deposits in brain measured by positron emission tomography
- Brain structure measured by magnetic resonance imaging
- Neuropsychological test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 PET, MRI, Neuropsychological test
Interventions/Control_2 PET, MRI, Neuropsychological test
Interventions/Control_3 PET, MRI, Neuropsychological test
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
50 years-old <=
Age-upper limit
84 years-old >=
Gender Male and Female
Key inclusion criteria Normal controls
- Subjects who have the ability to provide informed consent
- Memory Complaints
None
- Memory Function
Logical Memory II subscale (delayed Paragraph Recall) from the Wechsler Memory Scaled - Revised (the maximum score is 25):
a) more than or equal to 9 for 16 or more years of education
b) more than or equal to 5 for 10-15 years of education
c) more than or equal to 3 for 0-9 years of education
- MMSE
24-30
- CDR
0
Memory Box score must be 0
- General Cognition
Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
- Hachinski
Modified Hachinski score of less than or equal to 4

Mild cognitive impairment
- Memory Complaints
Memory complaint by subject or study partner that is verified by a study partner
- Memory Function
Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised:
a) less than or equal to 8 for 16 or more years of education
b) less than or equal to 4 for 10-15 years of education
c) less than or equal to 2 for 0-9 years of education
- MMSE
24-30
- CDR
0.5
Memory Box score must be at least 0.5
- General Cognition
General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit
- Hachinski
Modified Hachinski score of less than or equal to 4

Alzheimer's disease
- Memory Complaints
Memory complaint by subject or study partner that is verified by a study partner
- Memory Function
(Same as mild cognitive impairment)
- MMSE
12-26
- CDR
0.5-2
- General Cognition
NINCDS/ADRDA criteria for probable AD
- Hachinski
Modified Hachinski score of less than or equal to 4
Key exclusion criteria Exclusion criteria for patients
- Other psychiatric disorders including drug dependence
- Brain organic diseases including cerebrovascular diseases, Parkinson's disease and other related disorders
- Serious medical illness
- Subjects who are judged as not suitable for participation in this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ito, M.D., Ph.D.
Organization National Institute of Radiological Sciences
Division name Molecular Imaging Center
Zip code
Address 4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Institute of Radiological Sciences
Division name Molecular Imaging Center
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2008 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2008 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 10 Month 09 Day
Last modified on
2012 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001733

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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