UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A confirmatory multi-institutional joint research of the amyloid beta deposition in the brain of non-amnestic Alzheimer's disease and mild cognitive impairment patients
Title of the study (Brief title)	A clinical research of the cerebral amyloid beta deposition using amyloid-PET imaging in non-amnestic Alzheimer's disease and mild cognitive impairment patients
Region	Japan

Condition
Condition	non-amnestic Alzheimer's disease and mild cognitive impairment
Classification by specialty	Medicine in general Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The objective of this study is to visualize cerebral the amyloid beta deposition on non-amnestic Alzheimer's disease ( including mild cognitive impairment ) patients by amyloid-PET, dividing patients to amyloid positive and negative groups, and compare clinical symptoms, neuropsychological features, brain MRI, brain SPECT, etc. between two groups. We also compare the amyloid beta deposition between amnestic and non-amnestic Alzheimer's disease ( including mild cognitive impairment) patients.
Basic objectives2	Others
Basic objectives -Others	We research the core feature of non-amnestic Alzheimer's disease (including mild cognitive impairment) on cerebral amyloid beta deposition and clinical findings.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Outcomes are not applicable because this study is confirmatory research of small sample size and quantitative analysis is difficult.
Key secondary outcomes	Outcomes are not applicable because this study is confirmatory research of small sample size and quantitative analysis is difficult.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	All subjects undergo amyloid PET once within six months from the date of agreement in principle. Additional amyloid PET will be needed in case of unclear result.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjects who fulfill the following all criteria. A. Possible non-amnestic Alzheimer's disease (including mild cognitive impairment) patient whose clinical feature is one of the following. 1. language disorder type (logopenic aphasia type) 2. visuospatial disorder type (posterior cortical atrophy type ) 3. executive dysfunction type 4. corticobasal syndrome type B. Able to understand the research content and to sign the letter of informed consent by subject or study partner.
Key exclusion criteria	Subject who applies to any of the following criteria will be rejected. 1. Vascular dementia suspected by MRI, Hachinski score or NINDS-AIREN criteria. 2. Treatable dementia caused by metabolic disease, head trauma, normal pressure hydrocephalus (NPH), and so on. 3. Suspected psychiatric disorders, such as schizophrenia or major depression. 4. Cannot keep lying on bed for about 30 minutes. 5. Severe claustrophobia (fear of closed space). 6. MRI exclusions, such as presence of pacemaker or aneurysm clips. 7. Incapable of taking psychological test for any reason. 8. Pregnant woman suspected by medical interview. 9. Other exceptions considered by project leader or collaborators.
Target sample size	12

Research contact person
Name of lead principal investigator	Yasuji Yamamoto
Organization	Kobe University Graduate School of Medicine
Division name	Department of Biosignal Patho-physiology
Address	7-5-1, Kusunoki-cho, chuo-ku, Kobe, Japan
TEL	078-803-5243
Email	yamay@med.kobe-u.ac.jp

Public contact
Name of contact person	Kenichi Matsuyama
Organization	Kobe University Graduate School of Medicine
Division name	Department of Psychiatry
Address	7-5-1, Kusunoki-cho, chuo-ku, Kobe, Japan
TEL	078-382-6065
Homepage URL
Email	matu054909@yahoo.co.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Institute of biomedical research and innovation, Kobe
Name of secondary funｄer(s)	Institute of biomedical research and innovation, Kobe

Secondary IDs
Secondary IDs	YES
Study ID_1	15K09829
Org. issuing International ID_1	Japan Society for the Promotion of Science
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	神戸大学医学部附属病院（兵庫県）、先端医療センター（兵庫県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 04 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry	2019 Year 01 Month 31 Day
Date trial data considered complete	2019 Year 01 Month 31 Day
Date analysis concluded	2019 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	1. This study is a confirmatory research. Subject entry term is from the date of approval of Center for Clinical Research, Kobe University Hospital to March 31, 2020. 2. Psychiatrists of Kobe University Hospital explain the research content to possible non-amnestic Alzheimer's disease patients and their study partners, and get informed consent of subject entry. 3. We will carry out the following imaging test; amyloid PET, brain MRI, brain IMP-SPECT, MIBG myocardial scintigraphy(only for suspected Lewy body disease subjects), Dopamine transporter scintigraphy(only for suspected Lewy body disease subjects). 4. We will carry out the following neuropsychological tests(showing only the typical tests). Mini Mental State Examination(MMSE), Alzheimer's Disease Assessment Scale(ADAS), Frontal Assessment Battery(FAB), Clinical Dementia Rating(CDR), Clock Drawing Test(CDT), Rey Osterieth Complex Figure(ROCF), Wechsler Memory Scale-Revised(WMS-R), Western Aphasia Battery(WAB), Token Test 5. We will carry out the genetic test for the subjects who also agree the genetic test. We check the relationship between apolipoprotein E (ApoE) genetic variant and amyloid beta deposition of each subtype of non-amnestic Alzheimer's disease (including mild cognitive impairment).

Management information
Registered date	2016 Year 08 Month 07 Day
Last modified on	2019 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027093