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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016843
Receipt No. 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 2019/03/22

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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
Email 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
Email cr@nanpuh.or.jp

Sponsor
Institute Nanpuh Hospital
Institute
Department

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
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 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 No longer recruiting
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 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019555

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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