UMIN-CTR Clinical Trial

Public title

Elucidation of the pathophysiological mechanism of dementia and clinical research for creation of drug discovery targets

Acronym

Elucidation of the pathophysiological mechanism of dementia

Scientific Title

Elucidation of the pathophysiological mechanism of dementia and clinical research for creation of drug discovery targets

Scientific Title:Acronym

Elucidation of the pathophysiological mechanism of dementia

Region

Japan

Condition

neurodegenerative diseases

Classification by specialty

Neurology	Psychiatry	Radiology
Adult

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To elucidate the pathophysiological mechanism of dementia, especially Alzheimer's disease using tau/Amyloid PET imaging, CSF biomarker, Clinical/neuropsychological examinations and MRI.

Basic objectives2

Others

Basic objectives -Others

To accelerate the drug discovery for dementia though multimodal analysis using clinical data and multiomics study

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Clinical/neuropsychological examinations: WMS-R logical memory I & II, MMSE, CDR, FAQ, ADAS-cog, fluency, trail making test A & B(baseline, 1, 2, 3 years), JART (baseline)
Magnetic Resonance Imaging of brain (MRI)(baseline, 3 years)
Lumbar puncture: CSF is collected at baseline and in 3 years(baseline, 3 years)
Blood (baseline, 1, 2, 3 years), urine and feces collection (baseline and 3 years)
Amyloid PET and Tau PET imaging
Preparation of iN cell and iPS cell
APOE genotyping, whole genome sequencing
Multi-omics analysis: metabolomics, proteomics, lipidomics

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

amyloid PET (18F- Florbetaben 300MBq)
Tau PET (18F- PI-2620 185MBq or 18F- PM-PBB3 185MBq)

Timing: baseline and 3 years

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Selection criteria common to all subjects
1. The subject fully understands the contents of the research and written consent is obtained from the subject. If the attending physician considers that the subject's consent ability is not sufficient, document consent is obtained from the substitute.
2. In this research, we have newly registered the following healthy volunteers and patients who have no audio-visual disorder, normal writing ability and Japanese as their mother tongue.
Patients with normal subjects, Alzheimer's disease (AD), mild cognitive impairment (MCI), frontal temporal lobe degeneration (FTLD), head trauma, patients with Parkinson's disease or Parkinson's syndrome, senile psychosis, Lewy body Dementia (DLB)
3. Collaborators who have judged that a study partner is necessary by a doctor are subject to a study partner. Study partner should be conditioned, such as being physically and mentally healthy, having contact with subjects for more than 10 hours a week, accompanying all examination during the observation period etc.
4. No abnormalities that may interfere with participation in medical history, physical examination, general blood test findings.
5. There should be no severe diseases such as interruption or hospital treatment.
6. The woman is not pregnant or nursing.
7. Have the intention and ability to participate in 3 years of research.
8. The subjects agreed to receive MRI, tau PET, amyloid PET, blood test.
9. When taking concomitant restriction medicine, dosage regimen / dose must be stable for more than 12 weeks before screening.

Key exclusion criteria

1. When a cerebral infarction or a local lesion which affects infection or cognitive function is found by MRI at screening. Small infarcts in the deep area and diffuse changes in the white matter allow incorporation except those occurring in specific sites affecting cognitive function, but in principle cortical infarction is excluded.
2. There is a problem to take a MRI imaging due to pacemaker, aneurysm clip, artificial valve, cochlear implant or other magnetic or electrically conductive metal, or claustrophobia.
3. If you have psychiatric symptoms, excitability, behavior abnormalities that make it difficult to follow the protocol within the past 3 months.
4. When suffering from severe systemic disease or unstable disease.
5. There are abnormalities affecting cognitive function in vitamin B 12 deficiency, syphilis, thyroid function.
6. When performing lumbar puncture, if you are taking antiplatelet medications, take the following drug withdrawal period into consideration before the examination.
7. Subject is participating in any treatment drug trials.
8. It is clear that participation in clinical trials of Alzheimer's disease treatment drug is made during the 3-year research period.
9. When taking a combination prohibited medicine such as warfarin.
10. Huntington's disease, multiple cerebral infarction, normal pressure hydrocephalus, brain tumor, epilepsy, paroxysmal disease, subdural hematoma, multiple sclerosis.
11. When there is a history of juvenile onset normal schizophrenia.
12. It is judged by the attending physician not to be appropriate.

Target sample size

500

Name of lead principal investigator

1st name	Masaru
Middle name
Last name	Mimura

Organization

Keio University

Division name

School of Medicine

Zip code

1608582

Address

35 Shinanomachi, Shinjyuku-ku, Tokyo

TEL

+81-3-3353-1211

Email

mimura@a7.keio.jp

Name of contact person

1st name	Shogyoku
Middle name
Last name	Bun

Organization

Keio University

Division name

School of Medicine

Zip code

1608582

Address

35 Shinanomachi, Shinjyuku-ku, Tokyo

TEL

+81-3-3353-1211

Homepage URL

Email

shogybun@keio.jp

Institute

Keio University, School of Medicine

Institute

Department

Personal name

Organization

Eisai Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Keio University, School of Medicine

Address

35 Shinanomachi, Shinjyuku-ku, Tokyo

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2018

Year

03

Month

30

Day

Date of IRB

2018

Year

03

Month

30

Day

Anticipated trial start date

2018

Year

06

Month

01

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

03

Month

30

Day

Last modified on

2020

Year

04

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036545