UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018127 |
|---|---|
| Receipt number | R000020970 |
| Scientific Title | Effects of Suvorexant on sleep disorder and BPSD(Behavioral and Psychological Symptoms of Dementia) of Alzheimer's disease |
| Date of disclosure of the study information | 2015/06/30 |
| Last modified on | 2017/08/08 12:06:52 |
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Basic information
Public title
Effects of Suvorexant on sleep disorder and BPSD(Behavioral and Psychological Symptoms of Dementia) of Alzheimer's disease
Acronym
Effects of Suvorexant on sleep disorder and BPSD(Behavioral and Psychological Symptoms of Dementia) of Alzheimer's disease
Scientific Title
Effects of Suvorexant on sleep disorder and BPSD(Behavioral and Psychological Symptoms of Dementia) of Alzheimer's disease
Scientific Title:Acronym
Effects of Suvorexant on sleep disorder and BPSD(Behavioral and Psychological Symptoms of Dementia) of Alzheimer's disease
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We consider the effects of Suvorexant on insomnia of Alzheimer's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Actigraph, MMSE(Mini Mental State Examination), NPI(Neuropsychiatric Inventory), ZBI(Zarit Burden Interview), DRS(Delirium Rating Scale), ESS(Epworth Sleepiness Scale), ISI(Insomnia Severity Index)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Suvorexant 15mg/day for 4weeks
Interventions/Control_2
Ramelteon 8mg/day for 4weeks
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The Patient of Alzheimer's disease, it was judged the medical attendant to have the insomnia that treatment needed.
Key exclusion criteria
Patient with a history of the mental disorder, Patient with a history of the contusion of head, Patient with a history of the harmful use of Alcohol or drugs, Severe Alzheimer's disease, Patient who use psychotropic drugs, Resident of a nursing home, Patient who does not have a reliable caregiver
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryo Aoki |
Organization
Jikei university school of medicine
Division name
Psychiatry
Zip code
Address
3-25-8, Nishishinbashi, minato-ku, Tokyo
TEL
03-3433-1111
ryo-fcb@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Aoki |
Organization
Jikei university school of medicine
Division name
Psychiatry
Zip code
Address
3-25-8, Nishishinbashi, minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
ryo-fcb@samba.ocn.ne.jp
Sponsor or person
Institute
Department of Psychiatry, Jikei university school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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 | 06 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 30 | 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
| 2015 | Year | 06 | Month | 29 | Day |
Last modified on
| 2017 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020970
