Unique ID issued by UMIN | UMIN000018172 |
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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 |
attitude towards Food consumption in AD patients Revive with RIVastigmine Effects
Food-ARRIVE study
attitude towards Food consumption in AD patients Revive with RIVastigmine Effects
Food-ARRIVE study
Japan |
Alzheimer's disease (AD)
Neurology | Psychiatry |
Others
NO
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
Efficacy
Amount of meal actually eaten (average weight [%] of each meal eaten at each observation point)
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
Observational
Not applicable |
Not applicable |
Male and Female
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
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)
50
1st name | |
Middle name | |
Last name | Prof. Yu Nakamura |
Kagawa University Hospital
Department of Neuropsychiatry
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan 761-0793
087-891-2167
yunaka@med.kagawa-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroki Takayama |
Soiken Inc.
Division of Clinical Study Support
4th Floor, NBF Ogawa Bld., 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo, Japan 101-005
03-3295-1350
takayama@soiken.com
Kagawa University Hospital
Ono Pharmaceutical Co., Ltd.
Profit organization
Japan
NO
2015 | Year | 07 | Month | 02 | Day |
Unpublished
Completed
2015 | Year | 05 | Month | 19 | Day |
2015 | Year | 07 | Month | 15 | Day |
This clinical study is multi-institutional joint research.
2015 | Year | 07 | Month | 02 | Day |
2018 | Year | 03 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021050
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