臨床研究等提出・公開システム

Date of registration	Sept. 05, 2017
Last modified on	April. 25, 2019
Trial ID	jRCT2080223641

Scientific Title	A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer ' s Disease Dementia (Extension of Study AZES, The AMARANTH Study)
Public Title	I8D-MC-AZFD

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Eli Lilly Japan K.K.
	Address	-
	Phone Number	+81-120-023-812
	E-mail Address	-

Contact for Public Queries	Name
	Contact Name for Public Queries	Eli Lilly Japan K.K.
	Address	-
	Phone Number	+81-120-023-812
	E-mail Address	-

Recruitment Status	terminated

Date of First Enrolment		Aug. 27, 2017
Target Sample Size		1400
Study Type		Interventional
Study Design	Study Design	Study AZFD is a multicenter, randomized, parallel-group, double-blind, 104-week-long study of 2 fixed dose levels of LY3314814 in patients with early AD at the time of enrollment into the feeder Study AZES.
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Participants previously enrolled in AMARANTH (JapicCTI-152905) who meet eligibility criteria for delayed start I8D-MC-AZFD.
	Exclusion Criteria	Participants who participate in AMARANTH (JapicCTI-152905) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.
	Minimum Age	55age old over
	Maximum Age	85age old under
	Gender	Both
Health Condition or Problem Studied		Early Alzheimer's Disease Dementia
Intervention(s)		investigational material(s) Generic name etc : LY3314814 INN of investigational material : Lanabecestat Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : LY3314814 20 mg or 50 mg daily for 52 weeks, administered orally. control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		confirmatory The primary analysis of Study AZES-FD is to evaluate disease modification as outlined in Liu-Seifert (2015). This will be accomplished by testing the three delayed-start hypotheses in both doses of LY3314814 across Study AZES and up to Week 26 (Visit 7) of Study AZFD.
Secondary Outcome		safety Collect information in order to further characterize the safety and tolerability of LY3314814 in patients with early AD dementia (at the time of entry into Study AZES) efficacy To evaluate the disease modification of both doses of LY3314814 on functional and cognitive outcomes across Study AZES and up to Week 26 (Visit 7) of Study AZFD using the primary analysis methodology.

Primary Sponsor	Eli Lilly Japan K.K.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	-
Address of IRB	-
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	May. 17, 2017

Secondary ID No.	NCT02245737
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-173697
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/Europe/Oceania

History of Changes

No	Publication date
4	April. 25, 2019	(this page)	Changes
3	Dec. 17, 2018	Detail	Changes
2	Sept. 05, 2017	Detail	Changes
1	Sept. 05, 2017	Detail

List of change history