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

This study is currently recruiting participants.

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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

Purpose

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].

Condition	Intervention	Phase
Alzheimer's Disease	Drug: Aducanumab (BIIB037) Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Further study details as provided by Biogen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	1350
Actual Study Start Date:	August 31, 2015
Estimated Study Completion Date:	March 5, 2022
Estimated Primary Completion Date:	November 18, 2019 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	50 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02477800

Contacts


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

Show 187 Study Locations

Sponsors and Collaborators

Biogen

Investigators


Study Director:	Medical Director	Biogen

More Information

Additional Information:

US Residents may click here to find out more about participation in this trial This link exits the ClinicalTrials.gov site


Responsible Party:	Biogen
ClinicalTrials.gov Identifier:	NCT02477800 History of Changes
Other Study ID Numbers:	221AD301 2015-000966-72 ( EudraCT Number )
Study First Received:	June 18, 2015
Last Updated:	June 2, 2017

Keywords provided by Biogen:


BIIB037 Aducanumab

Additional relevant MeSH terms:


Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases	Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders

ClinicalTrials.gov processed this record on July 14, 2017

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