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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032027
Receipt No. R000036545
Scientific Title Elucidation of the pathophysiological mechanism of dementia and clinical research for creation of drug discovery targets
Date of disclosure of the study information 2018/03/31
Last modified on 2020/04/28

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Basic information
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
Condition neurodegenerative diseases
Classification by specialty
Neurology Psychiatry Radiology
Adult
Classification by malignancy Others
Genomic information YES

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization Eisai Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 31 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 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
Other related information

Management information
Registered date
2018 Year 03 Month 30 Day
Last modified on
2020 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036545

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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