UMIN-CTR Clinical Trial

Basic information
Public title	A study on donepezil pharmacokinetics and QT time
Acronym	A study on donepezil pharmacokinetics and QT time
Scientific Title	A study on donepezil pharmacokinetics and QT time
Scientific Title:Acronym	A study on donepezil pharmacokinetics and QT time
Region	Japan

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

Objectives
Narrative objectives1	To investigate whether blood concentration of donepezil is associated with QT time in patients taking donepezil.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between blood concentration of donepezil and QT time.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Taking donepezil
Interventions/Control_2	Not taking donepezil
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	As of January 1, 2019, outpatients over 65 years of age who had Alzheimer's disease and underwent treatment with donepezil at Tarumizu Chuo Hospital.
Key exclusion criteria	Taking anti-arrhythmic medications, a history of cardiac surgery including pacemaker implantation, and renal failure requiring hemodialysis.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name So Middle name Last name Kuwahata
Organization	Tarumizu Chuo Hospital, Tarumizu Municipal Medical Center
Division name	Department of Cardiovascular Medicine
Zip code	8912124
Address	1-140 Kinko-cho, Tarumizu City, Kagoshima, Japan
TEL	0994325211
Email	sokuwahata@ybb.ne.jp

Public contact
Name of contact person	1st name So Middle name Last name Kuwahata
Organization	Tarumizu Chuo Hospital, Tarumizu Municipal Medical Center
Division name	Department of Cardiovascular Medicine
Zip code	8912124
Address	1-140 Kinko-cho, Tarumizu City, Kagoshima, Japan
TEL	0994325211
Homepage URL
Email	sokuwahata@ybb.ne.jp

Sponsor
Institute	Tarumizu Chuo Hospital, Tarumizu Municipal Medical Center
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tarumizu Chuo Hospital, Tarumizu Municipal Medical Center
Address	1-140 Kinko-cho, Tarumizu City, Kagoshima, Japan
Tel	0994325211
Email	tarumizuhp@tarumizumh.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	2020 Year 08 Month 12 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	60
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Data analysis delay
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	Completed
Date of protocol fixation	2019 Year 02 Month 21 Day
Date of IRB	2019 Year 02 Month 21 Day
Anticipated trial start date	2019 Year 02 Month 22 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 08 Month 09 Day
Last modified on	2022 Year 02 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047219