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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
June 18, 2015
June 2, 2017
August 31, 2015
November 18, 2019   (Final data collection date for primary outcome measure)
Change from baseline in CDR-SB score [ Time Frame: Week 78 ]
Same as current
Complete list of historical versions of study NCT02477800 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
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
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].
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Aducanumab (BIIB037)
    Low dose
  • Drug: Aducanumab (BIIB037)
    High dose
  • Drug: Placebo
    Placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1350
March 5, 2022
November 18, 2019   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
No
Contact: Aducanumab Global Clinical Trial Center clinicaltrials@biogen.com
Contact: Aducanumab US Call Center 877-231-7271 clinicaltrials@biogen.com
Australia,   Austria,   Canada,   Denmark,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Portugal,   Spain,   Taiwan,   United Kingdom,   United States
Czech Republic,   Hungary
 
NCT02477800
221AD301
2015-000966-72 ( EudraCT Number )
Yes
Not Provided
Not Provided
Not Provided
Biogen
Biogen
Not Provided
Study Director: Medical Director Biogen
Biogen
June 2017

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