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

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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 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

Email

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


Email

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

Email

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


Research Plan
Registered date File name
2020/03/10 研究計画書ver5.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name