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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026924
Receipt No. R000030886
Scientific Title Study on concomitant use of memantine and antipsychotic drugs in patients with Alzheimer's disease
Date of disclosure of the study information 2017/04/10
Last modified on 2017/11/08

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Basic information
Public title Study on concomitant use of memantine and antipsychotic drugs in patients with Alzheimer's disease
Acronym Study on concomitant use of memantine and antipsychotic drugs in patients with Alzheimer's disease
Scientific Title Study on concomitant use of memantine and antipsychotic drugs in patients with Alzheimer's disease
Scientific Title:Acronym Study on concomitant use of memantine and antipsychotic drugs in patients with Alzheimer's disease
Region
Japan

Condition
Condition Alzheimer's disease
Classification by specialty
Neurology Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analyze using a clinical database the effects of memantine hydrochloride and cholinesterase inhibitor, both treatments for Alzheimer's type dementia, on the use prescription of psychotropic medicine.
Basic objectives2 Others
Basic objectives -Others Drug Utilization Study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Temporal change in the percentage of patients to which psychotropic drugs (antipsychotic, antidepressant, antianxiety and hypnotic drugs) are prescribed from 52 weeks before the start of prescription to the day before the prescription of memantine hydrochloride start date, and from the start of prescription of memantine hydrochloride to 52 weeks after or end of exposure.
Key secondary outcomes Temporal change in the percentage of patients to which psychotropic drugs (antipsychotic, antidepressant, antianxiety and hypnotic drugs) are prescribed from 52 weeks before the start of prescription to the day before the prescription of cholinesterase inhibitor start date, and from the start of prescription of cholinesterase inhibitor to 52 weeks after or end of exposure.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients of the Nihon University hospital, that were prescribed anti-Alzheimer drugs memantine hydrochloride, donepezil hydrochloride, galantamine hydrobromide or rivastigmine, between January 1, 2010 and September 30, 2016.
(1) Patients with medical records during the research period (January 1, 2010 - September 30, 2016)
(2) Patients to whom memantine hydrochloride, donepezil hydrochloride, galantamine hydrobromide or rivastigmine is prescribed.
(3) Patients who are 60 years of age or older at the time of "initial prescription" where initial prescription" is defined as the earliest prescription of one of the said Alzheimer drugs 52 or more weeks after the eligibility judgement date earlier day with a medical record within the research period.
Key exclusion criteria (1) Patients without a medical record between one day and 52 weeks before the date of initial prescription.
(2) Patients whose initial prescription day is October 1, 2015 or later.
(3) Patient who were prescribed an Anti-Alzheimer drug of the identical active ingredient between the day before to 52 weeks before the initial prescription date.
(4) Lewy body type dementia patients.
(5) Patients to whom memantine hydrochloride and cholinesterase inhibitor were initially prescribed on the same day.
(6) Patients with PDC (proportion of days covered i.e. percentage of days prescribed during the survey period) less than 80%.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Asai
Organization Nihon University
Division name Division of Pharmacology, Department of Biomedical Sciences, Nihon University School of Medicine Clinical Trials Research Center, School of Medicine
Zip code
Address Medical Faculty Clinical Trial Center 30-1 Oyaguchikamicho, Itabashi-ku, Tokyo
TEL 03-3972-8111(2770)
Email asai.satoshi@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Asai
Organization Nihon University
Division name Medical Faculty Clinical Trial Center
Zip code
Address Medical Faculty Clinical Trial Center 30-1 Oyaguchikamicho, Itabashi-ku, Tokyo
TEL 03-3972-8111(2770)
Homepage URL
Email asai.satoshi@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 日本大学医学部附属板橋病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Segmented regression analysis was performed with the changes in percentage of patients using psychotropic drugs (antipsychotics, antidepressants, anxiolytics, and hypnotics) 52 weeks before and after initial memantine prescription as the primary endpoint, and similarly for cholinesterase inhibitors (donepezil hydrochloride, galantamine hydrobromide, or rivastigmine) as secondary endpoints. There were 198 patients with Alzheimer's disease in the memantine group and 545 in the cholinesterase inhibitors group.
Difference in the slope of the regression line for proportions of patients using psychotropic drug before and after initial memantine was -0.74[95% confidence interval(CI):-1.01,-0.47] for antipsychotics,-0.29[95%CI:-0.47,-0.11] for antidepressants, and -1.01[95%CI:-1.33,-0.69] for hypnotics, and the proportion of patients using these drugs decreased over time with memantine prescription. Little change in anxiolytics use was observed (difference in the linear regression slope: 0.09[95%CI:-0.08,0.25]).
The proportion of Alzheimer's disease patients using antipsychotics, antidepressants, and hypnotics decreased over time after memantine initiation. These trends differ from those for cholinesterase inhibitors, suggesting memantine is distinct from cholinesterase inhibitors in the effects on the psychotropic drug usage.
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
2017 Year 02 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Regarding the effect of Anti-Alzheimer drug treatment on psychotropic drug administration, decreased prescription of antipsychotics after commencement of memantine prescription has been reported in a cohort study using British Clinical Practice Research Datalink (CPRD). However, there is no clear evidence in Japan.
Therefore, with reference to previous studies in the UK, we will analyze the effects of memantine hydrochloride and cholinesterase inhibitor, which are treatments for Alzheimer's type dementia in Japan, on the prescription of psychotropic medicine using a clinical database.

Management information
Registered date
2017 Year 04 Month 10 Day
Last modified on
2017 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030886

Research Plan
Registered date File name
2017/10/10 実施計画書(メマンチン)_18.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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