UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029415 |
|---|---|
| Receipt number | R000033044 |
| Scientific Title | Open-Label Study for reduction of brain amyloid beta (Abeta) by removal of blood Abeta in Alzheimer's Disease |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2021/04/07 12:20:07 |
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Basic information
Public title
Open-Label Study for reduction of brain amyloid beta (Abeta) by removal of blood Abeta in Alzheimer's Disease
Acronym
Open-Label Study for brain Abeta reduction by blood Abeta removal
Scientific Title
Open-Label Study for reduction of brain amyloid beta (Abeta) by removal of blood Abeta in Alzheimer's Disease
Scientific Title:Acronym
Open-Label Study for brain Abeta reduction by blood Abeta removal
Region
| Japan |
Condition
Condition
Alzheimer's Disease, Mild Cognitive Impairment
Classification by specialty
| Nephrology | Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of blood Abeta removal on brain Abeta in mild Alzheimer's disease and MCI patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of brain A beta measured by PIB/PET
from the starting point to the end of sequential treatments of blood A beta removal
Key secondary outcomes
Change of cognitive functions measured by MMSE,WMS-R, GDS, and ADAS-JCog, from the starting point to the end of sequential treatments of blood Abeta removal
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Removal of blood Abeta by apheresis
1) Devices for Abeta removal from the blood;
1-1) hexadecyl alkylated cellulose beads (HDC),
1-2) dialyzers made of polysulfone (PSf) or polyethersulfone (PES)
2) blood purification period; 1-3 hr
3) Protocol
3-1) Protocol A; 1 session/week x 24w. One or two series.
3-2) Protocol B; 1 session/week x 12w + 1/month x 9M
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Non diabetic MCI/mild AD patients whose Abeta deposition in the brain is confirmed by PIB/PET
Key exclusion criteria
1) diabetic patients
2) abnormal numbers of platelets or erythrocytes
3) with complications of severe circulatory or cardiac disorders
4) past medical history of cerebrovascular disease (infarction, bleeding etc.)
5) others whom the principal investigator decides to exclude
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Yuzawa |
Organization
Fujita Health University
Division name
Department of Nephrology, School of Medicine
Zip code
470-1192
Address
1-98 Kutsukake-cho, Toyoake, Aichi, 470-1192, Japan,
TEL
0562-93-2353
yukio-y@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | 1. Kazunori Kawaguchi 2. Midori Hasegawa |
Organization
Fujita Health University
Division name
1,3. Faculty of Clinical Engineering, School of Health Sciences, 2. Department of Nephrology, School
Zip code
470-1192
Address
1-98 Kutsukake-cho, Toyoake, Aichi, 470-1192, Japan,
TEL
0562-93-2619
Homepage URL
kkawagu@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Nephrology, School of Medicine, Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98 Kutsukake-cho, Toyoake, Aichi, 470-1192, Japan,
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2017 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 04 | Day |
Last modified on
| 2021 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033044
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
