UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025869
Receipt number R000029744
Scientific Title Investigation of the effect of rivastigmine patch on gait disturbance in patients with Alzheimer disease. Clinical study (intervention study).
Date of disclosure of the study information 2017/02/15
Last modified on 2019/01/28 14:57:19

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Basic information

Public title

Investigation of the effect of rivastigmine patch on gait disturbance in patients with Alzheimer disease. Clinical study (intervention study).

Acronym

Investigation of the effect of rivastigmine patch on gait disturbance in patients with Alzheimer disease. Clinical study (intervention study).

Scientific Title

Investigation of the effect of rivastigmine patch on gait disturbance in patients with Alzheimer disease. Clinical study (intervention study).

Scientific Title:Acronym

Investigation of the effect of rivastigmine patch on gait disturbance in patients with Alzheimer disease. Clinical study (intervention study).

Region

Japan


Condition

Condition

Alzheimer disease

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of the effect of rivastigmine patch on gait disturbance in patients with Alzheimer disease.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

gait speed, gait speed on dual task at 4weeks and 12 weeks after therapy.

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

Treatment

Type of intervention

Medicine

Interventions/Control_1

12 weeks
Rivastigmine patch
9mg and 18mg onece daily

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

50 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with Alzheimer disease

Key exclusion criteria

Patients with obvious motor disability
Patients who can not administer rivastigmine patch

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideki Shimura

Organization

Juntendo University Urayasu Hospital

Division name

Department of Neurology

Zip code


Address

2-1-1 Tomioka, Urayasu, Chiba 279-0021, Japan.

TEL

047-353-3111

Email

miurashimura@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Shimura

Organization

Juntendo University Urayasu Hospital

Division name

Department of Neurology

Zip code


Address

2-1-1 Tomioka, Urayasu, Chiba 279-0021, Japan.

TEL

047-353-3111

Homepage URL


Email

miurashimura@yahoo.co.jp


Sponsor or person

Institute

Juntendo University Urayasu Hospital

Institute

Department

Personal name



Funding Source

Organization

ONO PHARMACEUTICAL 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


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



Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 15 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

Completed

Date of protocol fixation

2016 Year 12 Month 16 Day

Date of IRB


Anticipated trial start date

2016 Year 12 Month 16 Day

Last follow-up date

2018 Year 08 Month 30 Day

Date of closure to data entry

2018 Year 12 Month 01 Day

Date trial data considered complete

2018 Year 12 Month 03 Day

Date analysis concluded

2018 Year 12 Month 08 Day


Other

Other related information



Management information

Registered date

2017 Year 01 Month 27 Day

Last modified on

2019 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029744


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name