UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052878 |
|---|---|
| Receipt number | R000007849 |
| Scientific Title | Effects of Rivastigmine on reactivity based on the cholinesterase polymorphism in Alzheimer's patients |
| Date of disclosure of the study information | 2023/11/24 |
| Last modified on | 2023/11/23 00:05:55 |
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Basic information
Public title
Effects of Rivastigmine on reactivity based on the cholinesterase polymorphism in Alzheimer's patients
Acronym
ERVIS trial
Scientific Title
Effects of Rivastigmine on reactivity based on the cholinesterase polymorphism in Alzheimer's patients
Scientific Title:Acronym
ERVIS trial
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the efficacy of a combined dementia prevention program (combined intervention of lifestyle management, exercise, nutrition, and cognitive training) in improving cognitive function and reducing cognitive decline in older adults at risk for dementia in a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change in cognitive function (composite score) from the time of enrollment to 18 months later. The composite score is calculated from the Z-scores of the MMSE, FCSRT, logical memory, DSST, TMT, counting, and word recall tasks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
The intervention group underwent 90 min of group-based weekly physical exercise, cognitive training, nutritional counseling, and vascular risk factor management for 18 months (78 sessions in total).
Interventions/Control_2
Information was provided to the control group about once every three months.
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were as follows: Tamba City resident, age 65-85 at enrollment, dementia assessment sheet 21 items in the community comprehensive care system (DASC-21) 10 score between 22 and 30, and at least one of the following as vascular risk: treated hypertension, systolic blood pressure over 140 mmHg or diastolic blood pressure over 85 mmHg, or treated diabetes (HbA1c over 6.0%) as vascular risk.
Key exclusion criteria
Those with a Mini-Mental State Examination (MMSE)11 score <24 and those already receiving public long-term care were excluded from the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hisatomo |
| Middle name | |
| Last name | Kowa |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku
TEL
078-796-4502
kowa@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yutaro |
| Middle name | |
| Last name | Oki |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku
TEL
078-796-4502
Homepage URL
oki@carp.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe Niversity
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University
Address
7-10-2 Tomogaoka Suma-ku, Kobe
Tel
078-796-4502
kowa@med.kobe-u.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
兵庫県
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 24 | 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
203
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
| 2020 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 23 | Day |
Last modified on
| 2023 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007849
