UMIN-CTR Clinical Trial

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
Email	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
Email	shinjim@fujita-hu.ac.jp

Sponsor
Institute	Department of Psychiatry, Fujita Health University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023250