臨床研究等提出・公開システム

Date of registration	Jan. 20, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080221701

Scientific Title	Clinical Study of SUN Y7017 (Memantine Hydrochloride) in Combination with Donepezil Hydrochloride in Patients with Moderate to Severe Alzheimer's disease.
Public Title	Clinical Study of SUN Y7017 (Memantine Hydrochloride)

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHISANKYO CO.,Ltd.
	Address	dsclinicaltrial@daiichisankyo.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		500
Study Type		Interventional
Study Design	Study Design	Multicenter, placebo-controlled, double-blind, parallel-group comparative study
Study Design	Objective
Phase		4
Key inclusion & exclusion criteria	Inclusion Criteria	1.Patients diagnosed with dementia of Alzheimer's type on the DSM-IV-TR and probable Alzheimer' disease on NINCDS-ADRDA diagnostic criteria. 2.Patients diagnosed with Alzheimer's disease on CT or MRI intracerebral scans. 3.Patients with MMSE score between 1 and 14. 4. Patients receiving cholinesterase inhibitors continuously before the start of the screening period. Annotation; donepezil hydrochloride must be taken for at least 4 weeks before the start of the screening period.
	Exclusion Criteria	1.Patients with a coexisting dementia other than Alzheimer's disease. 2.Patients with serious neuropathy complications. 3.Patients with musculoskeletal diseases that will hamper conduct of tests and observations in the present study. 4.Others, patients deemed not suitable to take part in the present study by the investigator.
	Minimum Age	50age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Moderate to severe Alzheimer's disease
Intervention(s)		investigational material(s) Generic name etc : SUN Y7017 INN of investigational material : Memantine Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : The starting dose is 5mg once daily. The dose should be increased in 5mg increments per week to 20mg control material(s) Generic name etc : Placebo INN of investigational material : None Therapeutic category code : --- Other Dosage and Administration for Investigational material : The placebo is administered once daily.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Evaluation of cognitive function Changes from baseline score (Week 24 - Week 0)
Secondary Outcome		Evaluation of behavioral and psychological symptoms of dementia, Evaluation by caregiver Changes from baseline score (Week 24- Week 0)

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-121743
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
17	Dec. 17, 2018	(this page)	Changes
16	Jan. 15, 2018	Detail	Changes
15	Jan. 10, 2018	Detail	Changes
14	Jan. 10, 2018	Detail	Changes
13	July. 18, 2017	Detail	Changes
12	July. 18, 2017	Detail	Changes
11	Mar. 15, 2017	Detail	Changes
10	Mar. 15, 2017	Detail	Changes
9	April. 27, 2015	Detail	Changes
8	April. 27, 2015	Detail	Changes
7	Mar. 27, 2014	Detail	Changes
6	Mar. 11, 2014	Detail	Changes
5	Mar. 11, 2014	Detail	Changes
4	Mar. 05, 2013	Detail	Changes
3	Mar. 05, 2013	Detail	Changes
2	Jan. 20, 2012	Detail	Changes
1	Jan. 20, 2012	Detail

List of change history