Unique ID issued by UMIN | UMIN000023528 |
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Receipt number | R000027093 |
Scientific Title | 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 |
Date of disclosure of the study information | 2016/08/08 |
Last modified on | 2019/02/12 11:50:47 |
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
A clinical research of the cerebral amyloid beta deposition using amyloid-PET imaging in non-amnestic Alzheimer's disease and mild cognitive impairment patients
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
A clinical research of the cerebral amyloid beta deposition using amyloid-PET imaging in non-amnestic Alzheimer's disease and mild cognitive impairment patients
Japan |
non-amnestic Alzheimer's disease and mild cognitive impairment
Medicine in general | Geriatrics | Psychiatry |
Others
YES
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.
Others
We research the core feature of non-amnestic Alzheimer's disease (including mild cognitive impairment) on cerebral amyloid beta deposition and clinical findings.
Exploratory
Not applicable
Outcomes are not applicable because this study is confirmatory research of small sample size and quantitative analysis is difficult.
Outcomes are not applicable because this study is confirmatory research of small sample size and quantitative analysis is difficult.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
NO
No need to know
1
Diagnosis
Device,equipment |
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.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
12
1st name | |
Middle name | |
Last name | Yasuji Yamamoto |
Kobe University Graduate School of Medicine
Department of Biosignal Patho-physiology
7-5-1, Kusunoki-cho, chuo-ku, Kobe, Japan
078-803-5243
yamay@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Kenichi Matsuyama |
Kobe University Graduate School of Medicine
Department of Psychiatry
7-5-1, Kusunoki-cho, chuo-ku, Kobe, Japan
078-382-6065
matu054909@yahoo.co.jp
Kobe University Graduate School of Medicine
Japan Society for the Promotion of Science
Japanese Governmental office
Japan
Institute of biomedical research and innovation, Kobe
Institute of biomedical research and innovation, Kobe
YES
15K09829
Japan Society for the Promotion of Science
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)
2016 | Year | 08 | Month | 08 | Day |
Unpublished
Completed
2016 | Year | 03 | Month | 04 | Day |
2016 | Year | 09 | Month | 01 | Day |
2019 | Year | 01 | Month | 31 | Day |
2019 | Year | 01 | Month | 31 | Day |
2019 | Year | 01 | Month | 31 | Day |
2019 | Year | 01 | Month | 31 | Day |
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).
2016 | Year | 08 | Month | 07 | Day |
2019 | Year | 02 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027093
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