UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Community pharmacist-based memantine medication counseling to improve medication adherence - PASM-study -
Title of the study (Brief title)	PASM-study
Region	Japan

Condition
Condition	Alzheimer's disease
Classification by specialty	Neurology Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effects of medication counseling intervation on the use of memantine with educational brochure by community pharmacist
Basic objectives2	Others
Basic objectives -Others	Medication persistence rate
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Medication persistence rate at 24 weeks
Key secondary outcomes	Medication Possession Ratio

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intensive medication counseling using educational brochure
Interventions/Control_2	Usual medication counseling
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	1.Patient who is/was newly prescribed memantine 2.Patient whom oral consent has been obtained for only the group of intensive medication counseling using educational brochure
Key exclusion criteria	-
Target sample size	300

Research contact person
Name of lead principal investigator	Keiko Yamamura
Organization	School of Pharmacy, Aichi Gakuin University
Division name	Clinical Pharmacy
Address	1-100 Kusumoto-cho, Chikusa-ku, Nagoya
TEL	052-757-6767
Email	keiko-y@dpc.agu.ac.jp

Public contact
Name of contact person	Norio Watanabe
Organization	School of Pharmacy, Aichi Gakuin University
Division name	Clinical Pharmacy
Address	1-100 Kusumoto-cho, Chikusa-ku, Nagoya
TEL	052-757-6766
Homepage URL
Email	norio-w@dpc.agu.ac.jp

Sponsor
Institute	Clinical Pharmacy, School of Pharmacy, Aichi Gakuin University
Institute
Department

Funding Source
Organization	DAIICHI SANKYO CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	MEM-DS-15016
Org. issuing International ID_1	DAIICHI SANKYO CO., LTD.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	株式会社ファーマホールディング（北海道）、株式会社サンメディック（東京都）、株式会社シー・アール・メディカル（愛知県）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 21 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 09 Month 16 Day
Anticipated trial start date	2016 Year 10 Month 22 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 02 Month 19 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 21 Day
Last modified on	2018 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028211