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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034032
Receipt No. R000038790
Scientific Title A pathophysiological study in diabetes-related dementia
Date of disclosure of the study information 2018/10/01
Last modified on 2019/03/07

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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
Middle name
Last name Hanyu Haruo
Organization Tokyo Medical University
Division name Geriatric Medicine
Zip code
Address 6-7-1 Nishishinjuku Shinjuku-ku Tokyo 160-0023
TEL 03-3342-6111
Email h-hanyu@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hanyu Haruo
Organization Tokyo Medical University
Division name Geriatric Medicine
Zip code
Address 6-7-1 Nishishinjuku Shinjuku-ku Tokyo 160-0023
TEL 03-3342-6111
Homepage URL
Email h-hanyu@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Department of Geriatric Medicine
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Hanyu H. Diabetes-related dementia. Dementia Japan 32:48-56, 2018

Management information
Registered date
2018 Year 09 Month 05 Day
Last modified on
2019 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038790

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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