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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016427
Receipt No. R000019072
Scientific Title Multicenter study on the diagnosis of Alzheimer's disease with FDG-PET---SDAF-PET(study on diagnosis of Alzheimer's disease with FDG-PET)
Date of disclosure of the study information 2015/02/03
Last modified on 2021/02/07

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Basic information
Public title Multicenter study on the diagnosis of Alzheimer's disease with FDG-PET---SDAF-PET(study on diagnosis of Alzheimer's disease with FDG-PET)
Acronym SDAF-PET
Scientific Title Multicenter study on the diagnosis of Alzheimer's disease with FDG-PET---SDAF-PET(study on diagnosis of Alzheimer's disease with FDG-PET)
Scientific Title:Acronym SDAF-PET
Region
Japan

Condition
Condition Alzheimer's disease, Frontotemporal lobar degeneration
Classification by specialty
Neurology Geriatrics Psychiatry
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the usefulness of positron emission tomography (PET) with 2-deoxy-2-[18F]fluoro-D- glucose (18FDG) (FDG-PET) in the diagnosis of Alzheimer's disease, this multicenter study of subjects with Alzheimer's disease (AD) and frontotemporal lobar degeneration (FTLD) will be conducted.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes A difference in sensitivity between FDG-PET scans and p-tau181 in CSF.
Key secondary outcomes 1)A difference in accuracy rate between FDG-PET scans and p-tau181 in CSF.
2)A comparison of the diagnostic performance between clinical diagnosis at month 0 in consideration of CSF biomarkers (tau and Abeta42) versus FDG-PET.
3)Inter-group analyses and other evaluations of FDG-PET scans, CSF biomarkers, MRI scans, and neuropsychological tests between patients with AD and FTLD.

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
55 years-old <=
Age-upper limit
84 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients with AD or FTLD whose native language is Japanese.
2)Patients signing written informed consent. If a patient is considered incapable of consenting, his/her legally acceptable representative is required to sign the consent form.
3)Patients with a study partner who is able to understand and evaluate the patient's situation.
A study partner is required:
1. To be healthy both physically and mentally, and
2. To have contact with the patient for at least 10 hours per week and be able to accompany the patient for all the visits during the participation in the study (excluding the patient's son(s) or daughter(s) living in a remote location).
4)Patients aged 55 years and older but younger than 84 years (at the time of informed consent).
5)Patients who can undergo PET scans.
Key exclusion criteria 1)Patients who have a previous history of or are under treatment for alcoholism.
2)Patients who have a previous history of or are under treatment for epilepsy.
3)Patients who have no more than 6 years of education.
4)Patients with diabetes who are currently receiving insulin therapy.
5)Patients who are currently receiving treatment with antidepressants, antipsychotics, or long-term sedative hypnotics (including anxiolytics).
6)Patients who had a diagnosis of major depression or bipolar disorder within the past year, those who have a previous history of schizophrenia, or those who are considered to have difficulty in completing the protocol due to severe manifestation of psychiatric symptoms, such as anxiety or irritation, within the last 3 weeks.
7)Patients with concurrent serious medical conditions (such as malignancy, heart failure, liver impairment, renal impairment, or endocrine disease).
8)Patients with MRI evidence of local lesions, such as cerebral infarcts, which might affect cognitive function.
Target sample size 190

Research contact person
Name of lead principal investigator
1st name Kengo
Middle name
Last name Ito
Organization National Center for Geriatrics and Gerontology
Division name Department of Radiology
Zip code 474-8511
Address 7-430, Morioka-cho, Obu-shi, Aichi 474-8511 Japan
TEL 0562-46-2311
Email kito@ncgg.go.jp

Public contact
Name of contact person
1st name Mayumi
Middle name
Last name Maeda
Organization National Center for Geriatrics and Gerontology
Division name Innovation Center for Clinical Research
Zip code 474-8511
Address 7-430, Morioka-cho, Obu-shi, Aichi 474-8511 Japan
TEL 0562-46-2311
Homepage URL
Email m-maeda@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Nihon Medi-Physics Co.,Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center for Geriatrics and Gerontology
Address 7-430, Morioka-cho Obu-shi, Aichi 474-8511 Japan
Tel 0562-46-2311
Email hirashm@ncgg.go.jp

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 浜松医科大学医学部附属病院(静岡県)、国立病院機構広島西医療センター(広島県)、川崎医科大学附属病院(岡山県)、近畿大学医学部付属病院(大阪府)、東京都健康長寿医療センター(東京都)、岡山旭東病院(岡山県)、大分大学医学部付属病院(大分県)、国立精神・神経医療研究センター(東京都)、産業医科大学病院(福岡県)、名古屋大学医学部付属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 03 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 138
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 No longer recruiting
Date of protocol fixation
2014 Year 09 Month 25 Day
Date of IRB
2013 Year 08 Month 16 Day
Anticipated trial start date
2015 Year 02 Month 04 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 01 Month 31 Day
Date trial data considered complete
2020 Year 02 Month 28 Day
Date analysis concluded
2021 Year 01 Month 31 Day

Other
Other related information Patients will be diagnosed clinically (clinical laboratory tests, neuropsychological tests, and MRI scans) as having either AD, FTLD, or non-AD/FTLD. Eligible subjects with AD or FTLD providing informed consent will undergo FDG-PET scans and cerebrospinal fluid (CSF) tests within 4 weeks. Neuropsychological tests and MRI scans will be repeated after 12 months. EDG-PET scans acquired at the time of enrollment will be subjected to image evaluation by visual inspection and qualitative region-of-interest (ROI) analysis with the clinical information, results of tests other than FDG-PET scans, and clinical course all blinded. The final clinical diagnosis based on a one-year clinical course will be used as the reference diagnosis to assess the diagnostic performance of FDG-PET scans.

Management information
Registered date
2015 Year 02 Month 03 Day
Last modified on
2021 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019072

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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