UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020128 |
|---|---|
| Receipt number | R000023250 |
| Scientific Title | Lithium for mild-to-moderate Alzheimer's disease: A randomized double-blind, placebo-controlled study |
| Date of disclosure of the study information | 2015/12/11 |
| Last modified on | 2020/12/12 13:44:57 |
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Basic information
Public title
Lithium for mild-to-moderate Alzheimer's disease: A randomized double-blind, placebo-controlled study
Acronym
Lithium for mild-to-moderate Alzheimer's disease: A randomized double-blind, placebo-controlled study
Scientific Title
Lithium for mild-to-moderate Alzheimer's disease: A randomized double-blind, placebo-controlled study
Scientific Title:Acronym
Lithium for mild-to-moderate Alzheimer's disease: A randomized double-blind, placebo-controlled study
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effect of lithium on patients with mild-to-moderate Alzheimer's disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
A change total score of Alzheimer's disease assessment scale-cognitive subscale from baseline to endpoint.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lithium, 300 micrograms/day, once daily, 52 weeks
Interventions/Control_2
Placebo, once daily, 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
Patients has probable Alzheimer's disease that met Diagnostic and Statistical Manual of Mental Disorders-V criteria.
Clinical Dementia Rating scores: 1 or 2
Key exclusion criteria
Creatinine clearance < 30
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nakao |
| Middle name | |
| Last name | Iwata |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref. 470-1192
TEL
0562-93-9250
nakao@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Matsunaga |
Organization
Fujita Health University School of Medicine
Division name
Department of Geriatrics and Cognitive Disorders
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref. 470-1192
TEL
0562-93-9250
Homepage URL
shinjim@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University Certified Clinical Research Review Board
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi Aichi
Tel
0562-93-2865
f-irb@fujita-hu.ac.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
| 2015 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2022 | 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
| 2015 | Year | 12 | Month | 09 | Day |
Last modified on
| 2020 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023250
