UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016843 |
|---|---|
| Receipt number | R000019555 |
| Scientific Title | Clinical study on the efficacy of Teprenone for the cognitive impairment in patients with Alzheimer's disease. |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2019/10/17 12:53:01 |
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Basic information
Public title
Clinical study on the efficacy of Teprenone for the cognitive impairment in patients with Alzheimer's disease.
Acronym
Clinical study on the efficacy of Teprenone for the cognitive impairment in patients with Alzheimer's disease.
Scientific Title
Clinical study on the efficacy of Teprenone for the cognitive impairment in patients with Alzheimer's disease.
Scientific Title:Acronym
Clinical study on the efficacy of Teprenone for the cognitive impairment in patients with Alzheimer's disease.
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology | Psychiatry | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to clarify the efficacy of Teprenone for the cognitive impairment in patients with Alzheimer's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of change of ADAS-J cog score from baseline
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Donepezil with Teprenone group
12 months
Interventions/Control_2
Donepezil with placebo group
12 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who visit the Division of Neurosurgery, Nanpuh Hospital, and Alzheimer's disease is diagnosed; a administration of Donepezil is appropriate, and an agreement is given by the person or family.
Key exclusion criteria
1) Patients with dementia except Alzheimer's disease
2) Patients with central nervous system infection
3) Normal pressure hydrocephalus merger patients
4) Patients that vitamin deficiency, electrolyte abnormality, a dysfunction thyroid are clear
5) Patients with schizophrenia
6) Patients with sensitivity to piperidine derivative containing donepezil or teprenone, Children, pregnant woman and lactating woman
7) Patients after the gallbladder extraction
8) Patients with visual disturbances, hearing impairment, and writing and literacy difficulties that affect the assessment of the neuropsychological test
9) Patients who received the drugs for Alzheimer's disease within 30 days before registration
10) Patients who received Teprenone 14 days before registration
11) Patients who are inappropriate to participate judge by attendant doctor
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichi Yokoyama |
Organization
Nanpuh Hospital
Division name
Division of Neurosurgery
Zip code
Address
14-3 Nagata Kagoshima 892-8512 JAPAN
TEL
099-226-9111
s-yokoyama@nanpuh.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masumi Nakasuji |
Organization
Nanpuh Hospital
Division name
Clinical Trials Support Office
Zip code
Address
14-3 Nagata Kagoshima 892-8512 JAPAN
TEL
099-226-9111
Homepage URL
cr@nanpuh.or.jp
Sponsor or person
Institute
Nanpuh Hospital
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 04 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 13 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 13 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 19 | Day |
Last modified on
| 2019 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019555
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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