臨床研究等提出・公開システム

Date of registration	May. 24, 2017
Last modified on	Sept. 17, 2020
Trial ID	jRCT2080223539

Scientific Title	A Phase III,Multicenter, Randomized,Double-Blind,Placebo-Controlled,Parallel-Group,Efficacy And Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease
Public Title	BN29553

Completion Date or Terminated date	May. 31, 2019
Actual Enrolled Number	806
Baseline Characteristics	The study was conducted at 209 centers in 27 countries.
Participant flow	A total of 806 participants were enrolled at 209 centers. The participants were randomized to receive either placebo or crenezumab in 1:1 ratio (399 randomized to placebo and 407 randomized to crenezumab).4 participants did not receive any study treatment meaning that the modified intent-to-treat and safety populations both consisted of 802 participants.
Adverse events	Overall, crenezumab was well tolerated and the observed safety profile in a prodromal to mild AD population in this study was consistent with crenezumab's safety profile as reported in previous trials. No new safety signals were identified. Full safety analysis results up to the final database lock are provided. Overall, the number of patients who experienced an AE was similar in the two treatment groups (placebo: 73.1%, 291 of 398 patients; crenezumab: 73.5%, 297 of 404 patients). AEs were mostly of mild-moderate severity and as expected in an elderly AD population.
Primary Outcome Measures	This study was discontinued based on a pre-planned interim analysis of the efficacy data from CREAD (BN29552; which was identical in design to BN29553), that indicated that crenezumab was unlikely to meet the primary endpoint of change from baseline in CDR-SB.No significant differences in change from baseline in CDR-SB scores were observed between crenezumab and placebo groups in the main analysis.
Secondary Outcome Measures	In three secondary endpoints analysed (ADCS ADL, MMSE, ADAS-Cog), small absolute differences were observed, favoring crenezumab in most post-baseline visits. This is likely due to sampling variability, though small, clinically unimportant, differences cannot be ruled out.
Brief summary	Crenezumab did not demonstrate evidence of clinically meaningful effects the primary endpoint and secondary endpoints. Crenezumab was safety and well-tolerated in patients with prodromal to mild AD. The steady-state mean trough concentrations of crenezumab were maintained throughout the treatment period.
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	Yes
Plan description	Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Chugai Pharmaceutical Co., Ltd.
	Address
	Phone Number
	E-mail Address	clinical-trials@chugai-pharm.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Chugai Pharmaceutical Co., Ltd.
	Address
	Phone Number
	E-mail Address	clinical-trials@chugai-pharm.co.jp

Recruitment Status	completed

Date of First Enrolment		Dec. 07, 2017
Target Sample Size		750
Study Type		Interventional
Study Design	Study Design	Multicenter,Randomized,Double-Blind,Placebo-Controlled,Parallel-Group
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	-Meet NIA-AA core clinical criteria for probable AD dementia or prodromal AD -Having mild symptomatology, as defined by a screening MMSE score of 22 points and higher, and CDR-GS of 0.5 or 1.0 etc.
	Exclusion Criteria	-Any evidence of a condition other than AD that may affect cognition -Meet the exclusion criteria of MRI at screening etc.
	Minimum Age	50age old over
	Maximum Age	85age old under
	Gender	Both
Health Condition or Problem Studied		Alzheimer's disease(AD)
Intervention(s)		investigational material(s) Generic name etc : Crenezumab INN of investigational material : Crenezumab Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : Crenezumab or placebo will be intravenously infused every 4 weeks over 100 weeks. 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		safety efficacy Observation/Examination
Secondary Outcome		pharmacokinetics pharmacodynamics Examination

Primary Sponsor	CHUGAI PHARMACEUTICAL CO.,LTD.
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	Aug. 28, 2018

Secondary ID No.	NCT03114657
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-173594
Name of Other Registries

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

History of Changes

No	Publication date
9	Sept. 17, 2020	(this page)	Changes
8	Sept. 25, 2019	Detail	Changes
7	Dec. 17, 2018	Detail	Changes
6	Sept. 12, 2018	Detail	Changes
5	Sept. 12, 2018	Detail	Changes
4	Dec. 14, 2017	Detail	Changes
3	Dec. 14, 2017	Detail	Changes
2	May. 24, 2017	Detail	Changes
1	May. 24, 2017	Detail

List of change history