Trial record 2 of 5 for:    biogen 221ad

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 2015 by Biogen
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT02477800
First received: June 18, 2015
Last updated: June 26, 2015
Last verified: June 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Change from baseline in CDR-SB score [ Time Frame: Week 78 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in MMSE score [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
  • Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 items) (ADAS-Cog 13) [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1350
Study Start Date: June 2015
Estimated Study Completion Date: February 2022
Estimated Primary Completion Date: February 2020 (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
Genders Eligible for Study:   Both
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

  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: Biogen clinicaltrials@biogen.com

Locations
United States, Arizona
Research Site Recruiting
Tuscon, Arizona, United States, 85718
United States, California
Research Site Not yet recruiting
Fullerton, California, United States, 92835
Research Site Not yet recruiting
Simi Valley, California, United States, 93065
United States, Florida
Research Site Not yet recruiting
Delray Beach, Florida, United States, 33445
Research Site Recruiting
Fort Myers, Florida, United States, 33912
Research Site Not yet recruiting
Miami, Florida, United States, 33175
Research Site Not yet recruiting
Miami, Florida, United States, 33137
Research Site Not yet recruiting
Orlando, Florida, United States, 32806
United States, Illinois
Research Site Not yet recruiting
Elk Grove Village, Illinois, United States, 60007
United States, Kentucky
Research Site Recruiting
Lexington, Kentucky, United States, 40503
United States, Nevada
Research Site Not yet recruiting
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Research Site Not yet recruiting
Toms River, New Jersey, United States, 08755
United States, Virginia
Research Site Not yet recruiting
Norfolk, Virginia, United States, 23502
Research Site Not yet recruiting
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

No publications provided

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02477800     History of Changes
Other Study ID Numbers: 221AD301, 2015-000966-72
Study First Received: June 18, 2015
Last Updated: June 26, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Spanish Agency for Medicines and Health Products
Switzerland: Swissmedic
United States: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Korea: Ministry of Food and Drug Safety
Australia: Department of Health and Ageing Therapeutic Goods Administration
Denmark: Danish Health and Medicines Authority
Taiwan: Department of Health
Austria: Agency for Health and Food Safety
Czech Republic: State Institute for Drug Control
Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM)
Sweden: Medical Products Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Authority of Medicines and Health Products, IP (INFARMED)
Germany: Paul-Ehrlich-Institut
Italy: The Italian Medicines Agency

Keywords provided by Biogen:
BIIB037
Aducanumab

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on July 01, 2015