UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021140 |
|---|---|
| Receipt number | R000024388 |
| Scientific Title | A study to evaluate combination therapy of memantine hydrochloride with donepezil hydrochloride compared with dose escalation of donepezil hydrochloride in the patient with Alzheimer's disease who have treated with donepezil hydrochloride |
| Date of disclosure of the study information | 2016/02/26 |
| Last modified on | 2017/04/26 08:28:14 |
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Basic information
Public title
A study to evaluate combination therapy of memantine hydrochloride with donepezil hydrochloride compared with dose escalation of donepezil hydrochloride in the patient with Alzheimer's disease who have treated with donepezil hydrochloride
Acronym
A study to evaluate combination therapy of memantine hydrochloride with donepezil hydrochloride compared with dose escalation of donepezil hydrochloride in the patient with Alzheimer's disease who have treated with donepezil hydrochloride
Scientific Title
A study to evaluate combination therapy of memantine hydrochloride with donepezil hydrochloride compared with dose escalation of donepezil hydrochloride in the patient with Alzheimer's disease who have treated with donepezil hydrochloride
Scientific Title:Acronym
A study to evaluate combination therapy of memantine hydrochloride with donepezil hydrochloride compared with dose escalation of donepezil hydrochloride in the patient with Alzheimer's disease who have treated with donepezil hydrochloride
Region
| Japan |
Condition
Condition
severe Alzheimer's disease
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the efficacy of combination therapy of memantine hydrochloride 20mg/day with donepezil hydrochloride 5mg/day compared with dose escalation of donepezil hydrochloride 10mg/day
in the patient with severe Alzheimer's disease who have treated with donepezil hydrochloride 5mg/day. Safety is also considered.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
･ MMSE, NPI-D-J, CGI-C, FAST, J-ZBI_8 and QLDJ after 24 weeks
･ Incidence of adverse events and adverse drug reactions until after 24 weeks
Key secondary outcomes
･ MMSE, NPI-D-J, CGI-C, FAST, J-ZBI_8 and QLDJ after 52 weeks
･ Incidence of adverse events and adverse drug reactions until after 52 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
donepezil hydrochloride 5mg/day and memantine hydrochloride 20mg/day
treatmet period: 52 weeks
Interventions/Control_2
donepezil hydrochloride 10mg/day
treatmet period: 52 weeks
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
1.Patient diagnosed with dementia of the Alzheimerz's type based on the DSM-IV-TR and probable Alzheimer's disease on NINCDS-ADRDA
2.Patient diagnosed with Alzheimer's disease on MRI and SPECT intracerebral scans
3.Patient with severe Alzheimer's disease
4.Patient who has been treated with donepezil hydrochloride 5mg/day for at least 12 weeks before registration, and the patient who needs to change his/her treatment by the researcher's judgement
5.Patient's living environment allows for appropriate efficacy and safety evaluation in the present study
6.Patient who can visit the clinic with the information providers who can routinely observe his/her dementia symptoms, ADL and adverse events
7.Patient from whom consent has been appropriately obtained (informed consent should be obtained from the patient him/herself to the extent possible;consent must be obtained from patient's proxy consenter)
Key exclusion criteria
1.Patient with dementia except for Alzheimer's disease
2.Patient with any of the following diseases or symtoms
･ Severe impairment of heart, hepatic or renal
･ Poorly controlled diabetes
･ Serious neuropathy complications or musculoskeletal diseases
･ Other poorly controlled diseases
3.Patient with a history of hyperesthesia to memantine hydrochloride
4.Patient with a history of the side effect at the dose escalation of cholinesterase inhibitor
5.Patient who have taken memantine hydrochloride within 24 weeks before registration
6.Other patients deemed not suitable to take part in the present study by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SADAO KATAYAMA |
Organization
Katayama Medical Clinic
Division name
Internal Medicine , Neurology
Zip code
Address
1-26, Kotobukicho, Kurashiki-shi, Okayama
TEL
086-422-0753
sadaokatayama@katayama-med.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SEIICHIRO TSUNEYUKI |
Organization
DAIICHI DANKYO RD NOVARE CO., LTD.
Division name
Clinical Development Department
Zip code
Address
1-2-58, Hiromachi, Shinagawa-ku, Tokyo
TEL
03-5436-8543
Homepage URL
tsuneyuki.seiichiro.xh@rdn.daiichisankyo.co.jp
Sponsor or person
Institute
DAIICHI SANKYO CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO CO., LTD.
Organization
Division
Category of Funding Organization
Profit 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
片山内科クリニック
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 22 | Day |
Last modified on
| 2017 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024388
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| Registered date | File name |
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