221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (ENGAGE)

This study is currently recruiting participants.

See

Contacts and Locations

Verified June 2017 by Biogen

Sponsor:

Information provided by (Responsible Party):

Biogen

ClinicalTrials.gov Identifier:

NCT02477800

First received: June 18, 2015

Last updated: June 2, 2017

Last verified: June 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

June 18, 2015

Last Updated Date

June 2, 2017

Actual Start Date ^ICMJE

August 31, 2015

Estimated Primary Completion Date

November 18, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in CDR-SB score [ Time Frame: Week 78 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT02477800 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in MMSE score [ Time Frame: Week 78 ]
Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 items) (ADAS-Cog 13) [ Time Frame: Week 78 ]
Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) (ADCS-ADL-MCI) score [ Time Frame: Week 78 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

Official Title ^ICMJE

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

Brief Summary

The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: Aducanumab (BIIB037)
Low dose
Drug: Aducanumab (BIIB037)
High dose
Drug: Placebo
Placebo

Study Arms

Experimental: Low Dose
Monthly intravenous (IV) infusion
Interventions:
- Drug: Aducanumab (BIIB037)
- Drug: Placebo
Experimental: High Dose
Monthly intravenous (IV) infusion
Interventions:
- Drug: Aducanumab (BIIB037)
- Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1350

Estimated Completion Date

March 5, 2022

Estimated Primary Completion Date

November 18, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Key Inclusion Criteria:

Must meet all of the following clinical criteria for MCI due to AD or mild AD and must have:
A Clinical Dementia Rating (CDR)-Global Score of 0.5.
Objective evidence of cognitive impairment at screening
An MMSE score between 24 and 30 (inclusive)
Must have a positive amyloid Positron Emission Tomography (PET) scan
Must consent to apolipoprotein E (ApoE) genotyping
If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening visit 1
Must have a reliable informant or caregiver

Key Exclusion Criteria:

Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment
Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
Clinically significant unstable psychiatric illness in past 6 months
History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening
Indication of impaired renal or liver function
Have human immunodeficiency virus (HIV) infection
Have a significant systematic illness or infection in past 30 days
Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
Any contraindications to brain magnetic resonance imaging (MRI) or PET scans
Alcohol or substance abuse in past 1 year
Taking blood thinners (except for aspirin at a prophylactic dose or less)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Sex/Gender

Sexes Eligible for Study:

All

Ages

50 Years to 85 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Aducanumab Global Clinical Trial Center		clinicaltrials@biogen.com
Contact: Aducanumab US Call Center	877-231-7271	clinicaltrials@biogen.com

Listed Location Countries ^ICMJE

Australia, Austria, Canada, Denmark, France, Germany, Italy, Japan, Korea, Republic of, Portugal, Spain, Taiwan, United Kingdom, United States

Removed Location Countries

Czech Republic, Hungary

Administrative Information

NCT Number ^ICMJE

NCT02477800

Other Study ID Numbers ^ICMJE

221AD301
2015-000966-72 ( EudraCT Number )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Biogen

Study Sponsor ^ICMJE

Biogen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director

Biogen

PRS Account

Biogen

Verification Date

June 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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