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History of Changes for Study: NCT02477800
221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (ENGAGE)
Latest version (submitted August 9, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 18, 2015 None (earliest Version on record)
2 June 26, 2015 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 July 2, 2015 Contacts/Locations and Study Status
4 July 9, 2015 Contacts/Locations and Study Status
5 July 31, 2015 Contacts/Locations and Study Status
6 August 6, 2015 Contacts/Locations and Study Status
7 August 14, 2015 Contacts/Locations and Study Status
8 August 20, 2015 Contacts/Locations and Study Status
9 September 3, 2015 Contacts/Locations and Study Status
10 September 17, 2015 Contacts/Locations and Study Status
11 October 8, 2015 Contacts/Locations and Study Status
12 October 16, 2015 Contacts/Locations and Study Status
13 October 23, 2015 Contacts/Locations and Study Status
14 November 5, 2015 Contacts/Locations and Study Status
15 November 12, 2015 Contacts/Locations and Study Status
16 November 19, 2015 Contacts/Locations and Study Status
17 November 30, 2015 Contacts/Locations and Study Status
18 December 3, 2015 Contacts/Locations and Study Status
19 December 10, 2015 Contacts/Locations and Study Status
20 January 8, 2016 Contacts/Locations and Study Status
21 January 14, 2016 Contacts/Locations and Study Status
22 February 25, 2016 Contacts/Locations and Study Status
23 March 3, 2016 Contacts/Locations and Study Status
24 March 10, 2016 Contacts/Locations and Study Status
25 March 18, 2016 Contacts/Locations and Study Status
26 March 25, 2016 Contacts/Locations and Study Status
27 April 21, 2016 Contacts/Locations, Study Status, References and Study Description
28 August 1, 2016 Contacts/Locations and Study Status
29 September 1, 2016 Contacts/Locations and Study Status
30 September 23, 2016 Contacts/Locations and Study Status
31 October 4, 2016 Contacts/Locations and Study Status
32 October 20, 2016 Contacts/Locations, References, Study Description and Study Status
33 October 27, 2016 Contacts/Locations and Study Status
34 November 30, 2016 Contacts/Locations and Study Status
35 January 12, 2017 Contacts/Locations and Study Status
36 January 13, 2017 Study Status
37 January 19, 2017 Contacts/Locations and Study Status
38 January 26, 2017 Contacts/Locations and Study Status
39 March 1, 2017 Contacts/Locations and Study Status
40 March 21, 2017 Contacts/Locations and Study Status
41 May 14, 2017 Study Status, Contacts/Locations, References and Eligibility
42 June 2, 2017 Contacts/Locations and Study Status
43 July 17, 2017 Contacts/Locations and Study Status
44 August 15, 2017 Contacts/Locations and Study Status
45 September 13, 2017 Contacts/Locations and Study Status
46 October 1, 2017 Study Status and Contacts/Locations
47 November 7, 2017 Contacts/Locations and Study Status
48 December 12, 2017 Contacts/Locations and Study Status
49 January 19, 2018 Contacts/Locations and Study Status
50 February 16, 2018 Study Status and Contacts/Locations
51 March 21, 2018 Study Status and Study Design
52 April 10, 2018 Contacts/Locations and Study Status
53 April 19, 2018 Contacts/Locations and Study Status
54 May 14, 2018 Study Status and Contacts/Locations
55 July 17, 2018 Study Status and Contacts/Locations
56 August 3, 2018 Recruitment Status, Study Status and Contacts/Locations
57 April 22, 2019 Study Status and Study Description
58 November 5, 2019 Recruitment Status, Study Status, Study Design and Study Description
59 November 7, 2019 Study Description and Study Status
60 August 5, 2020 Study Status
61 August 7, 2020 Study Status
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Results Submission Events
62 August 9, 2021 Outcome Measures, Study Status, More Information, Document Section, Adverse Events, Baseline Characteristics, Participant Flow and Study Design
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Study NCT02477800
Submitted Date:  June 18, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: 221AD301
Brief Title: 221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (ENGAGE)
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
Secondary IDs: 2015-000966-72 [EudraCT Number]
Open or close this module Study Status
Record Verification: June 2015
Overall Status: Not yet recruiting
Study Start: August 2015
Primary Completion: February 2020 [Anticipated]
Study Completion: February 2022 [Anticipated]
First Submitted: June 18, 2015
First Submitted that
Met QC Criteria:
June 18, 2015
First Posted: June 23, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 18, 2015
Last Update Posted: June 23, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Biogen
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Alzheimer's Disease
Keywords: BIIB037
Aducanumab
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 1350 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change from baseline in CDR-SB score
[ Time Frame: Week 78 ]

Secondary Outcome Measures:
1. Change from baseline in MMSE score
[ Time Frame: Week 78 ]

2. Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 items) (ADAS-Cog 13)
[ Time Frame: Week 78 ]

3. 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 ]

Open or close this module Eligibility
Minimum Age: 50 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
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 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

Open or close this module Contacts/Locations
Central Contact Person: Biogen
Email: clinicaltrials@biogen.com
Study Officials: Medical Director
Study Director
Biogen
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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