UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Imaging study using positron emission tomography with AV-45 for dementia
Title of the study (Brief title)	Positron emission tomography for dementia
Region	Japan

Condition
Condition	dementia
Classification by specialty	Neurology Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the distribution and deposits of beta-amyloid in brain using positron emission tomography and the correlation between the imaging data and cognitive function in Alzheimer's disease and mild cognitive impairment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amyloid deposits and distribution in brain measured by positron emission tomography among patients and age-matched normal controls.
Key secondary outcomes	To investigate the correlation between the cognitive function, brain MRI, and FDG-PET and amyloid deposits.

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	5
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	PET, MRI, Neuropsychological test
Interventions/Control_5	PET, MRI, NEuropsychological test
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects who have the ability to provide informed consent and adhere to the protocol. Normal controls: - Without past or current history of cognitive dysfunction - Mini-Mental State Exam score is 28 or more Alzheimer's disease: - Subject who meet the diagnostic criteria of Alzheimer's disease on International classification of Diseases 10th revision - Informed consents are obtained from patients and one of their family members Mild cognitive impairment: - Memory complaints by subject that is verified by a study partner - Objective cognitive impairment - General cognition and functional performance sufficiently preserved - Not meet the criteria of dementia Mental disorder with cognitive impairment Age-related macular degeneration
Key exclusion criteria	Exclusion criteria: - With past or current history of serious medical illness and/or brain organic diseases - Subject who is contraindicated for the use of MRI - With past or current history of severe liver disease, kidney disease, heart disease, allergy, or severe drug allergy - Subjects who are judged as not suitable for participation in this study
Target sample size	75

Research contact person
Name of lead principal investigator	Yoshiro Okubo, M.D., Ph.D.
Organization	Nippon Medical School
Division name	Department of Neuropsychiatry
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL	03-3822-2131
Email	okubo-y@nms.ac.jp

Public contact
Name of contact person	Amane Tateno, M.D., Ph.D.
Organization	Nippon Medical School
Division name	Department of Neuropsychiatry
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL	03-3822-2131
Homepage URL
Email	amtateno@nms.ac.jp

Sponsor
Institute	Nippon Medical School
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)

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	日本医科大学付属病院健診医療センター、日本医科大学付属病院、メディカルサテライト八重洲クリニック神田分院

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 12 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 04 Month 16 Day
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date	2017 Year 04 Month 01 Day
Date of closure to data entry	2017 Year 07 Month 01 Day
Date trial data considered complete	2017 Year 10 Month 01 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 05 Month 12 Day
Last modified on	2017 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004374