UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054123 |
|---|---|
| Receipt number | R000061800 |
| Scientific Title | Exploring the effects of suvorexant on sleep and blood biomarkers in Alzheimer's disease |
| Date of disclosure of the study information | 2024/04/11 |
| Last modified on | 2024/04/11 15:32:33 |
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Basic information
Public title
Exploring the effects of suvorexant on sleep and blood biomarkers in Alzheimer's disease
Acronym
Exploring the effects of suvorexant on sleep and blood biomarkers in Alzheimer's disease
Scientific Title
Exploring the effects of suvorexant on sleep and blood biomarkers in Alzheimer's disease
Scientific Title:Acronym
Exploring the effects of suvorexant on sleep and blood biomarkers in Alzheimer's disease
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore whether suvorexant increases REM sleep and affects blood biomarker amyloid-beta 42/40 ratio in patients with Alzheimer's disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of REM sleep duration and amyloid-beta 42/40 ratio before and after administration of suvorexant
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of suvorexant
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1, Meet the diagnostic criteria for Alzheimer's disease and insomnia of DSM-5.
2, MMSE score is 21 or higher.
3, The patient dose not use benzodiazepines, antipsychotics, antidepressants, antiepileptics, antiparkinsonian drugs, antihistamines, or orexin receptor antagonists.
Key exclusion criteria
1, Comorbid dementia other than Alzheimer's disease.
2, Comorbid schizophrenia, mood disorder, anxiety disorder, drug/substance addiction, or personality disorder.
3, Serious physical illnesses such as cerebrovascular disease, cardiac disease, renal dysfunction, and neurological disease.
4, The patient has a coexisting sleep-related breathing disorder (respiratory event index of 10 or more on the apnomonitor).
5, The principal investigator or attending physician determines that the subject is unsuitable for the study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tanaka |
Organization
Kurita hospital
Division name
psychiatry
Zip code
3900921
Address
695 Kurita, Nagano City, Nagano Prefecture
TEL
0262261311
a-tanaka@kuritahp.or.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Tanaka |
Organization
Kurita hospital
Division name
psychiatry
Zip code
3900921
Address
695 Kurita, Nagano City, Nagano Prefecture
TEL
0262261311
Homepage URL
a-tanaka@kuritahp.or.jp
Sponsor or person
Institute
Kurita hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurita hospital
Address
695 Kurita, Nagano City, Nagano Prefecture
Tel
0262261311
a-tanaka@kuritahp.or.jp
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
| 2024 | Year | 04 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 11 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061800
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
