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

August 9, 2021 updated by: Biogen

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].

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1653

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital Sydney
      • East Gosford, New South Wales, Australia, 2250
        • Central Coast Neurosciences Research, Gosford
      • Erina, New South Wales, Australia, 2250
        • Central Coast Neurosciences Research
      • North Ryde, New South Wales, Australia, 2113
        • KARA Institute for Neurological Diseases
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • The Prince Charles Hospital
      • Herston, Queensland, Australia, 4006
        • Royal Brisbane and Women's Hospital
      • Toowoomba, Queensland, Australia, 4350
        • Toowoomba Base Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
    • Western Australia
      • West Perth, Western Australia, Australia, 6005
        • Neurodegenerative Disorders Research
  • Austria
      • Graz, Austria, 8036
        • Lkh - Universitaetsklinikum Graz
      • Salzburg, Austria, 5020
        • Christian-Doppler-Klinik - Universitätsklinikum Salzburg
  • Canada
      • Quebec, Canada, G1J 1Z4
        • CHU de Quebec - Hôpital de l' Enfant Jésus
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Heritage Medical Research Clinic
    • British Columbia
      • Penticton, British Columbia, Canada, V2A 5C8
        • The Medical Arts Health Research Group
      • Vancouver, British Columbia, Canada, V6T 2B5
        • UBC Hospital
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Hospital
      • Toronto, Ontario, Canada, M3B 2S7
        • Toronto Memory Program (Neurology Research Inc.)
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • The Montreal Neurological Institute
      • Verdun, Quebec, Canada, H4H 1R3
        • McGill Centre for Studies in Aging
  • Denmark
      • Ballerup, Denmark, 2750
        • CCBR - Ballerup - DK
      • København Ø, Denmark, 2100
        • Rigshospitalet
      • Vejle, Denmark, 7100
        • CCBR - Vejle - DK
      • Ålborg, Denmark, 9100
        • CCBR - Ålborg - DK
  • France
      • Paris, France, 75013
        • Groupe Hospitalier Pitie-Salpetriere
      • Paris, France, 75013
        • Groupe hospitalier Broca - La Rochefoucauld - La Collégiale
    • Bas Rhin
      • Strasbourg, Bas Rhin, France, 67091
        • Hopital Louis Pasteur Colmar
      • Strasbourg Cedex, Bas Rhin, France, 67098
        • CHU Strasbourg - Hôpital Hautepierre
    • Gironde
      • Bordeaux, Gironde, France, 33076
        • Groupe Hospitalier Pellegrin - Hôpital Pellegrin
    • Marne
      • Reims, Marne, France, 51092
        • CHU Reims - Hôpital Maison Blanche
    • Rhone
      • Bron Cedex, Rhone, France, 69677
        • Hopital Neurologique Pierre Wertheimer
  • Germany
      • Berlin, Germany, 14050
        • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
    • Baden Wuerttemberg
      • Boeblingen, Baden Wuerttemberg, Germany, 71034
        • Praxis Dr. Scholz
      • Ostfildern, Baden Wuerttemberg, Germany, 73760
        • Aerztliche Gemeinschaftspraxis
      • Stuttgart, Baden Wuerttemberg, Germany, 70182
        • Neuro MVZ Stuttgart
    • Bayern
      • Frankfurt, Bayern, Germany, 97080
        • Klinikum Der Johann Wolfgang Goethe-Universitaet
      • Neuburg, Bayern, Germany, 86633
        • Praxis Dr. med. Bergmann
    • Hessen
      • Kassel, Hessen, Germany, 34121
        • Neurologische Gemeinschaftspraxis Kassel
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
        • Klinische Forschung Hannover-Mitte GmbH
    • Nordrhein Westfalen
      • Aachen, Nordrhein Westfalen, Germany, 52074
        • Universitaetsklinikum Aachen AOeR
      • Bonn, Nordrhein Westfalen, Germany, 53127
        • Universitaetsklinikum Bonn AoeR
      • Cologne, Nordrhein Westfalen, Germany, 53105
        • Universitaetsklinikum Koeln
  • Italy
      • Bergamo, Italy, 24100
        • Azienda Ospedaliera Ospedali Riuniti di Bergamo
      • Brescia, Italy, 25100
        • Azienda Ospedaliera Spedali Civili di Brescia
      • Genova, Italy, 16132
        • Azienda Ospedaliero Universitaria San Martino
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Milano, Italy, 20144
        • Casa di Cura del Policlinico
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria "Federico II"
      • Napoli, Italy, 80138
        • Seconda Università degli Studi di Napoli
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Roma, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
      • Salerno, Italy, 84131
        • Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
      • Siena, Italy, 53100
        • A.O.U. Senese Policlinico Santa Maria alle Scotte
    • Ancona
      • Torrette Di Ancona, Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria Ospedali Riuniti
    • Palermo
      • Cefalù, Palermo, Italy, 90015
        • Fondazione Istituto G.Giglio di Cefalù
  • Japan
      • Itabashi-ku, Japan, 173-8610
        • Research Site
      • Itabashi-ku, Japan, 173-0015
        • Research Site
      • Kiyose-shi, Japan
        • Research Site
      • Kodaira-shi, Japan, 187-8551
        • Research Site
    • Chiba-Ken
      • Chiba-Shi, Chiba-Ken, Japan, 263-0043
        • Research Site
      • Inzai-shi, Chiba-Ken, Japan
        • Research Site
    • Fukuoka-ken
      • Kurume-shi, Fukuoka-ken, Japan, 830-0011
        • Research Site
    • Fukushima-Ken
      • Aizuwakamatsu-shi, Fukushima-Ken, Japan, 965-8585
        • Research Site
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 070-8644
        • Research Site
      • Sapporo-shi, Hokkaido, Japan, 006-8555
        • Research Site
      • Sapporo-shi, Hokkaido, Japan, 064-8570
        • Research Site
    • Kanagawa-Ken
      • Atsugi-shi, Kanagawa-Ken, Japan, 243-8551
        • Research Site
      • Kamakura-shi, Kanagawa-Ken, Japan, 247-8533
        • Research Site
      • Kawasaki-Shi, Kanagawa-Ken, Japan, 211-8533
        • Research Site
      • Yokohama-shi, Kanagawa-Ken, Japan, 225-0013
        • Research Site
      • Yokohama-shi, Kanagawa-Ken, Japan, 225-0025
        • Research Site
    • Kanagawa-ken
      • Yokohama-shi, Kanagawa-ken, Japan, 223-0059
    • Kyoto-Fu
      • Kyoto-shi, Kyoto-Fu, Japan, 616-8255
        • Research Site
    • Niigata-Ken
      • Nagaoka-shi, Niigata-Ken, Japan, 940-2081
        • Research Site
    • Saitama-Ken
      • Iruma-gun, Saitama-Ken, Japan, 350-0495
        • Research Site
      • Kasukabe-shi, Saitama-Ken, Japan, 344-0036
        • Research Site
    • Tokyo
      • Ota-ku, Tokyo, Japan, 143-8541
        • Research Site
    • Tokyo-To
      • Bunkyo-ku, Tokyo-To, Japan, 113-0034
        • Research Site
      • Shinjuku-ku, Tokyo-To, Japan, 162-8655
        • Research Site
      • Shinjuku-ku (I), Tokyo-To, Japan, 162-8655
        • Research Site
    • Yamagata-Ken
      • Yamagata-shi, Yamagata-Ken, Japan, 990-0834
        • Research Site
  • Korea, Republic of
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of, 143-729
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
    • Gyeonggi-do
      • Incheon, Gyeonggi-do, Korea, Republic of, 22332
        • Inha University Hospital
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
  • Portugal
      • Amadora, Portugal, 2720-276
        • Hospital Professor Doutor Fernando Fonseca, E.P.E.
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Coimbra, Portugal, 3040-278
        • Centro Hospitalar e Universitario de Coimbra E.P.E
      • Lisboa, Portugal, 1600-618
        • CUF Alvalade
      • Loures, Portugal, 2674-514
        • Hospital Beatriz Ângelo
      • Torres Vedras, Portugal, 2560-280
        • Campus Neurológico Sénior
  • Spain
      • Barcelona, Spain, 08041
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08028
        • Fundació ACE
      • Madrid, Spain, 28006
        • Clinica Ruber
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46017
        • Hospital Universitario Dr. Peset
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20014
        • Policlinica Guipuzcoa
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Hospital de Cruces
  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taoyuan County, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou
  • United Kingdom
    • Avon
      • Bristol, Avon, United Kingdom, BS16 1LE
        • Southmead Hospital
    • Greater London
      • London, Greater London, United Kingdom, W1G 9JF
        • Re:Cognition Health Ltd
      • London, Greater London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, Greater London, United Kingdom, WC1N 3BG
        • The National Hospital for Neurology and Neurosurgery Centre
    • Greater Manchester
      • Salford, Greater Manchester, United Kingdom, M6 8HD
        • Salford Royal
    • Lothian Region
      • Edinburgh, Lothian Region, United Kingdom, EH8 9YL
        • The University of Edinburgh
    • Merseyside
      • Blackburn, Merseyside, United Kingdom, BB3 2HH
        • Manchester Royal Infirmary
    • Somerset
      • Bath, Somerset, United Kingdom, BA1 3NG
        • The RICE Centre
    • Strathclyde
      • Glasgow, Strathclyde, United Kingdom, G20 0XA
        • Glasgow Memory Clinic Ltd
      • Glasgow, Strathclyde, United Kingdom, G21 3UW
        • Stobhill ACH Hospital
    • Tayside Region
      • Dundee, Tayside Region, United Kingdom, DD2 1GZ
        • Ninewells Hospital
    • Tyne & Wear
      • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE4 5PL
        • Newcastle University
    • Wiltshire
      • Chippenham, Wiltshire, United Kingdom, SN15 1GG
        • Kingshill Research Centre
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center
      • Tucson, Arizona, United States, 85718
        • Center for Neurosciences
    • California
      • Fullerton, California, United States, 92835
        • Neurology Center of North Orange County
      • Laguna Hills, California, United States, 92653
        • Senior Clinical Trials, Inc.
      • Lomita, California, United States, 90717
        • Torrance Clinical Research Institute, Inc.
      • Los Angeles, California, United States, 90095
        • University of California - Los Angeles
      • San Francisco, California, United States, 94158
        • UCSF - Memory and Aging Center
      • Sherman Oaks, California, United States, 91403
        • California Neuroscience Research Medical Group Inc.
      • Simi Valley, California, United States, 93065
        • Southern California Research LLC
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Institute for Neurodegenerative Disorders
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University Hospital
    • Florida
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research, Inc.
      • Fort Myers, Florida, United States, 33912
        • Neuropsychiatric Research Center of Southwest Florida
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33137
        • Miami Jewish Health Systems
      • Orlando, Florida, United States, 32806
        • Compass Research Main
      • Palm Beach Gardens, Florida, United States, 33410
        • Palm Beach Neurological Center
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials, LLC
      • Tampa, Florida, United States, 33634
        • Meridien Research
      • Tampa, Florida, United States, 33616
        • USF Health Byrd Institute
      • The Villages, Florida, United States, 32162
        • Compass Research Main
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida - Weston
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Neurosciences Institute
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Neurological Center
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center Research Institute, Inc.
      • Wichita, Kansas, United States, 67214
        • Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hosp End/Dbt
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices & Research
      • Plymouth, Massachusetts, United States, 02360
        • Donald S. Marks, M.D., P.C.
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Washington University
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Advanced Memory Research Institute of NJ, PC
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • New York, New York, United States, 10016
        • New York University Medical Center PRIME
      • Rochester, New York, United States, 14620
        • University of Rochester
    • North Carolina
      • Charlotte, North Carolina, United States, 28270
        • ANI Neurology, PLLC d/b/a Alzheimer's Memory Center
      • Raleigh, North Carolina, United States, 27607-6010
        • Raleigh Neurology Associates, P.A.
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
      • Plains, Pennsylvania, United States, 18705
        • Northeastern Pennsylvania Memory and Alzheimer's Center
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Rhode Island Mood & Memory Research Institute
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
    • Tennessee
      • Cordova, Tennessee, United States, 38108
        • Neurology Clinic, PC
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center. Knoxville
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center at Dallas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Virginia
      • Richmond, Virginia, United States, 23294
        • National Clinical Research Inc.-Richmond
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53266
        • Medical College of Wisconsin, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Dose
Monthly intravenous (IV) infusion
Drug: Placebo
Placebo
Drug: Aducanumab (BIIB037)
Low dose
Drug: Aducanumab (BIIB037)
High dose
Experimental: High Dose
Monthly intravenous (IV) infusion
Drug: Placebo
Placebo
Drug: Aducanumab (BIIB037)
Low dose
Drug: Aducanumab (BIIB037)
High dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 78
Time Frame: Baseline, Week 78
CDR-SB integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following caregiver interview and systematic patient examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. Prespecified severity anchors range from none = 0, questionable = 0.5, mild = 1, moderate = 2 to severe = 3 (the personal care domain omits the 0.5 score). "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18 that can change in increments of 0.5 or greater. Higher scores indicate greater disease severity. Mixed model for repeated measures (MMRM) analysis was used to analyze change from baseline in CDR-SB. A positive change from baseline indicates clinical decline.
Baseline, Week 78

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 78
Time Frame: Baseline, Week 78
The MMSE is a widely used performance-based test of global cognitive status. It consists of 11 tasks that assess orientation, word recall, attention and calculation, language abilities, and visuospatial functions. The scores from the 11 tests are combined to obtain the total score, which ranges from 0 to 30, with lower scores over time indicating increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in MMSE. A negative change from baseline indicates clinical decline.
Baseline, Week 78
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 Items) (ADAS-Cog 13) Score at Week 78
Time Frame: Baseline, Week 78
ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The scale items capture word recall, ability to follow commands, the ability to correctly copy or draw an image, naming, the ability to interact with everyday objects, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure for delayed word recall and concentration/distractibility. The total score ranges from 0 to 85. An increase in score over time indicates increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in ADAS-Cog 13. A positive change from baseline indicates clinical decline.
Baseline, Week 78
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL-MCI) Score at Week 78
Time Frame: Baseline, Week 78
The ADCS-ADL-MCI consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the patient's actual functioning over the previous month and provide an assessment of change in the functional state of the participant over time. The total score ranges from 0 to 53, with lower values over time reflecting functional deterioration. MMRM analysis was used to analyze change from baseline in ADAS-ADL-MCI. A negative change from baseline indicates clinical decline.
Baseline, Week 78

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 221AD301
  • 2015-000966-72 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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