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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023528
Receipt No. 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

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Basic information
Public 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
Acronym A clinical research of the cerebral amyloid beta deposition using amyloid-PET imaging in non-amnestic Alzheimer's disease and mild cognitive impairment patients
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
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuji Yamamoto
Organization Kobe University Graduate School of Medicine
Division name Department of Biosignal Patho-physiology
Zip code
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
1st name
Middle name
Last name Kenichi Matsuyama
Organization Kobe University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Completed
Date of protocol fixation
2016 Year 03 Month 04 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000027093

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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