UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023528
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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Kobe University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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