UMIN-CTR Clinical Trial

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	https://rctportal.niph.go.jp/s/detail/um?trial_id=jRCTs041180098#
Publication of results	Published

Result
URL related to results and publications	https://jrct.niph.go.jp/latest-detail/jRCTs041180098
Number of participants that the trial has enrolled	138
Results	The diagnostic performance of FDG-PET in the differential diagnosis of AD and FTLD is higher than that of p-tau181 in CSF. In addition, there is no problem with the safety of FDG-PET.
Results date posted	2022 Year 02 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Date of informed consent, patient enrollment number, gender, age, height, weight, education history, disease name, eligibility criteria for AD, eligibility criteria for FTLD, and presence or absence of local lesions on MRI
Participant flow	Of the 135 subjects who underwent FDG-PET, 19 subjects (22 events) had adverse events, but none had a causal relationship to FDG-PET. Two serious adverse events occurred in 2 subjects (2 events). Both events were due to cerebrospinal fluid sampling and were judged as not related to FDG-PET.
Adverse events	Of the 135 subjects who underwent FDG-PET, 19 subjects (22 events) had adverse events, but none had a causal relationship to FDG-PET. Two serious adverse events occurred in 2 subjects (2 events). Both events were due to cerebrospinal fluid sampling and were judged as not related to FDG-PET.
Outcome measures	In this study, the primary endpoint was the difference in sensitivity between FDG-PET (tomographic imaging + 3D-SSP) and p-tau181 in CSF in the differential diagnosis of AD and FTLD. As a result, the sensitivity of FDG-PET (tomographic image + 3D-SSP) was 94%, the sensitivity of p-tau181 in CSF was 62%. The sensitivity of FDG-PET (tomographic image + 3D-SSP) was 32% higher than that of p-tau181 in CSF. The accuracy of FDG-PET (tomographic image + 3D-SSP) was 92%, and p-tau181 in CSF was 65%. The accuracy of FDG-PET (tomographic image + 3D-SSP) was 27% higher than that of p-tau181 in CSF.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
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	2022 Year 02 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019072