UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034032 |
|---|---|
| Receipt number | R000038790 |
| Scientific Title | A pathophysiological study in diabetes-related dementia |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2020/03/10 11:25:13 |
* 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 pathophysiological study in diabetes-related dementia
Acronym
A pathophysiology in diabetes-related dementia
Scientific Title
A pathophysiological study in diabetes-related dementia
Scientific Title:Acronym
A pathophysiology in diabetes-related dementia
Region
| Japan |
Condition
Condition
Dementia associated with dementia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pathophysiological study
Basic objectives2
Others
Basic objectives -Others
Propose of clinical criteria
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amyloid and tau accumulation on PET
Key secondary outcomes
Amyloid and tau measurements in cerebrospinal fluid
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Dementia associated with diabetes
Key exclusion criteria
Severe dementia
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Haruo |
| Middle name | |
| Last name | Hanyu |
Organization
Tokyo Medical University
Division name
Geriatric Medicine
Zip code
160-0023
Address
6-7-1 Nishishinjuku Shinjuku-ku Tokyo 160-0023
TEL
03-3342-6111
h-hanyu@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Haruo |
| Middle name | |
| Last name | Hanyu |
Organization
Tokyo Medical University
Division name
Geriatric Medicine
Zip code
160-0023
Address
6-7-1 Nishishinjuku Shinjuku-ku Tokyo 160-0023
TEL
03-3342-6111
Homepage URL
h-hanyu@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Department of Geriatric Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Metropolitan Geriatric Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University
Address
6-7-1 Nishishinjuku Shinjuku-ku Tokyo
Tel
03-3342-6111
Adm-IRB@tokyo-med.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
東京医科大学
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We studied amyloid (PiB) PET in 31 patients with cognitive impairment and dementia associated with type 2 diabetes mellitus, including 16 with Alzheimer disease (AD), 10 with mild cognitive impairment (MCI), and 5 with other types of dementia. Our PET study showed that 63% (10/16) of patients with AD, 40% (4/10) of patients with MCI, and 40% (2/5) of patients with other types of dementia showed amyloid positivity. Our results suggest that there are subgroups with neuronal damage independent of amyloid pathology among patients with clinically diagnosed AD associated with DM.
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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Takenoshita N, Shimizu S, Kanetaka H, Sakurai H, Suzuki R, Miwa T, Odawara M, Ishii K, Shimada H, Higuchi M, Suhara T, Hanyu H. Classification of clinically diagnosed Alzheimer disease associated with diabetes based on amyloid and tau PET results. J Alzheimers Dis 2019;71:261-271.
Management information
Registered date
| 2018 | Year | 09 | Month | 05 | Day |
Last modified on
| 2020 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038790
