UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of combination therapy of Donepezil and Memary for moderate to severe Alzheimer's disease
Title of the study (Brief title)	The effect of combination therapy of Donepezil and Memary for moderate to severe Alzheimer's disease
Region	Japan

Condition
Condition	moderate to severe Alzheimer's disease
Classification by specialty	Neurology Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will examine both usefulness and safety about combination therapy of Donepezil and Memantine.
Basic objectives2	Others
Basic objectives -Others	We will utilize the results mentioned above for the new strategic drug therapy for the patients of Alzheimer's disease.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	We will carry out tree contents of SIB, FAST and MMSE for 3 times at every 12 week-point during 24 weeks from the start-point of medication and evaluate the results of usefulness.
Key secondary outcomes	We will carry out two contents of NPI-D and ADCS-ADL for 3 times at every 12 week-point during 24 weeks from the start-point of medication and evaluate the results of usefulness.

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 considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A;At first, donepezil (10mg/day) for 24weeks continuously. Memantine is added at 5mg/day (W13)to 20mg/day at W16 (+5mg/day per every 1 week). As a result, donepezil (10mg/day) +memantine (20mg/day) from W16 to W24. The number of times of medication: 1/day
Interventions/Control_2	Group B;At first, donepezil is fixed at 5mg/day continuously from W1 to W13. And from W14 to W24, donepezil is up to 10mg/day. Memantine start from W1 at 5mg/day and adding up to 20mg/day at W4 (+5mg/day per every 1 week). As a result, from W4 to W24, memantine is continuously fixed at 20mg/day. As a result, donepezil (10mg/day) +memantine (20mg/day) from W13 to W24. The number of times of medication: 1/day
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Inclusion Criteria:Diagnosed as Alzheimer's disease with DSM-4. Severity of dementia: FAST5-6. Medication: Donepezil 5mg/day >=6 months continuously as stable.
Key exclusion criteria	Patients with contraindication for donepezil or/and memantine. Patients who is judged as inappropriate for entry to this study.
Target sample size	100

Research contact person
Name of lead principal investigator	YASUJI YAMAMOTO
Organization	Kobe University Graduate School of Medicine
Division name	Department of Psychiatry
Address	7-5-2, Kusuniki-cho, Chuo-ku, Kobe, Hyogo
TEL	078-382-6065
Email	yamay@med.kobe-u.ac.jp

Public contact
Name of contact person	YASUJI YAMAMOTO
Organization	Kobe University Graduate School of Medicine
Division name	Department of Psychiatry
Address	7-5-2, Kusuniki-cho, Chuo-ku, Kobe, Hyogo
TEL	078-382-6065
Homepage URL
Email	yamay@med.kobe-u.ac.jp

Sponsor
Institute	YASUJI YAMAMOTO
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)

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	神戸大学附属病院（兵庫県神戸市）

Other administrative information
Date of disclosure of the study information	2011 Year 09 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 08 Month 31 Day
Anticipated trial start date	2011 Year 09 Month 01 Day
Last follow-up date	2016 Year 03 Month 01 Day
Date of closure to data entry	2016 Year 09 Month 01 Day
Date trial data considered complete	2017 Year 03 Month 01 Day
Date analysis concluded	2017 Year 07 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 06 Month 29 Day
Last modified on	2017 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006942