UMIN-CTR Clinical Trial

Basic information
Public title	Preventive effect of minocycline on postoperative cognitive dysfunction in Japanese elderly patients: A randomized, double-blind, placebo-controlled trial
Acronym	MINOPOC-J
Scientific Title	Preventive effect of minocycline on postoperative cognitive dysfunction in Japanese elderly patients: A randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym	MINOPOC-J
Region	Japan

Condition
Condition	The elderly patient who undergoes total knee arthroplasty(TKA)
Classification by specialty	Orthopedics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is investigating whether minocycline has a preventive effect on postoperative cognitive dysfunction (POCD). We are going to give minocycline or placebo to elderly patients undergoing TKA to compare the cognitive function before and ater surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	We are going to evaluate the cognitive function 1 week and 3 months after the surgery to test whether minocycline can decrease the incidence of POCD.
Key secondary outcomes	We are going to compare the incident rate of delirium between minocycline and placebo group within 1 week after surgery.

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	Administration of 200 mg minocycline per day from 1 day before to 7 days after surgery
Interventions/Control_2	Administration of a placebo(sugar) from 1 day before to 7 days after surgery
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	60 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) The patient who has a score of 15 or more in MoCA-J test 2) The patient with PS1 or PS2 3) The patient gave written informed consent
Key exclusion criteria	1)The patient with the mental disease 2)The patient with the drug dependency or alcoholism 3)The patient with cardiac disease 4)The patient with hepatic disease 5)The patient with renal disease 6)The patient with allergy to tetracycline including minocycline 7)The patient taking calcium, magnesium, aluminum, lantern, iron medicine, anticoagulant,sulfonylurea-based hypoglycemic drug, methotrexate, porfimer sodium, digoxin,oral contraceptive, vitamine A 8)The patient to whom a doctor judged inappropriate for participating in this study
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Tomonori Middle name Last name TAKAZAWA
Organization	Gunma University Hospital
Division name	Intenisive Care Unit
Zip code	371-8511
Address	3-39-15 Showa-machi, Maebashi , Gunma, Japan 371-8511
TEL	027-220-8698
Email	takazawt@gunma-u.ac.jp

Public contact
Name of contact person	1st name Tomonori Middle name Last name TAKAZAWA
Organization	Gunma University Hospital
Division name	Department of Anesthesiology
Zip code	371-8511
Address	3-39-15 Showa-machi, Maebashi , Gunma, Japan 371-8511
TEL	027-220-8454
Homepage URL
Email	takazawt@gunma-u.ac.jp

Sponsor
Institute	Gunma University Hospital, Department of Anesthesiology
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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	Gunma University Hospital Clinical Research Review Board
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
Tel	027-220-8740
Email	gunmaciru-office@umin.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	群馬中央病院（群馬県）

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 24 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	No longer recruiting
Date of protocol fixation	2014 Year 07 Month 23 Day
Date of IRB	2014 Year 07 Month 24 Day
Anticipated trial start date	2015 Year 12 Month 06 Day
Last follow-up date	2020 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	2014 Year 07 Month 23 Day
Last modified on	2020 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016796