UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018172
Receipt number R000021050
Scientific Title attitude towards Food consumption in AD patients Revive with RIVastigmine Effects
Date of disclosure of the study information 2015/07/02
Last modified on 2018/03/09 13:28:38

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Basic information

Public title

attitude towards Food consumption in AD patients Revive with RIVastigmine Effects

Acronym

Food-ARRIVE study

Scientific Title

attitude towards Food consumption in AD patients Revive with RIVastigmine Effects

Scientific Title:Acronym

Food-ARRIVE study

Region

Japan


Condition

Condition

Alzheimer's disease (AD)

Classification by specialty

Neurology Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1) To evaluate the efficacy of rivastigmine on treating AD patients with attenuated appetite (effects on the amount of food intake, time spent on food intake, and cognitive abilities, etc.)

2) To evaluate any effects on caregivers' burdens

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Amount of meal actually eaten (average weight [%] of each meal eaten at each observation point)

Key secondary outcomes

Following outcomes are evaluated
for the amount of changes:
1. Time spend on lunch
2. Body weight
3. Scores of NPI-NH
4. Scores of MMSE


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Those who meet all of the following criteria are included in this study:

1) Patients who are admitted into the institutions

2) Patients with Alzheimer's disease

3) Patients who are on rivastigmine for the first time as for dementia medications, within the range of a health insurance coverage (also patients switching to rivastigmine from other medication can participate in this study)

4) Patients who are diagnosed as having decreased appetite, and needed assistance at mealtime

5) Patients who can sign and return their consent form, or their proxies can provide written consent on behalf of the patients

Key exclusion criteria

Patients who fall into any of the following criteria are excluded from this study:

1) Patients with a history of hypersensitivity to components of rivastigmine or to carbamate derivative

2) Patients with physical disabilities which interfere their food intake

3) Patients with life threating disease such as malignancy, pneumonia, etc.

4) Patients with a gastrointestinal disorder

5) Patients with conditions that are judged by physicians to be inappropriate to this study

6) Patients who need to start, or continue to use donepezil hydrochloride (drugs for dementia of Alzheimer type and Levy body), or galantamine hydrobromide (drug for dementia of Alzheimer type)

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Prof. Yu Nakamura

Organization

Kagawa University Hospital

Division name

Department of Neuropsychiatry

Zip code


Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan 761-0793

TEL

087-891-2167

Email

yunaka@med.kagawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Takayama

Organization

Soiken Inc.

Division name

Division of Clinical Study Support

Zip code


Address

4th Floor, NBF Ogawa Bld., 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo, Japan 101-005

TEL

03-3295-1350

Homepage URL


Email

takayama@soiken.com


Sponsor or person

Institute

Kagawa University Hospital

Institute

Department

Personal name



Funding Source

Organization

Ono Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

2015 Year 07 Month 02 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

2015 Year 05 Month 19 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This clinical study is multi-institutional joint research.


Management information

Registered date

2015 Year 07 Month 02 Day

Last modified on

2018 Year 03 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021050


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name