UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	attitude towards Food consumption in AD patients Revive with RIVastigmine Effects
Title of the study (Brief title)	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	Prof. Yu Nakamura
Organization	Kagawa University Hospital
Division name	Department of Neuropsychiatry
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	Hiroki Takayama
Organization	Soiken Inc.
Division name	Division of Clinical Study Support
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
Institute	Kagawa University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021050