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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018127
Receipt No. 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

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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
Email 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
Email ryo-fcb@samba.ocn.ne.jp

Sponsor
Institute Department of Psychiatry, Jikei university school of medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020970

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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