Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease (TANGO)

October 18, 2022 updated by: Biogen

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease

The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD.

The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

654

Phase

  • Phase 2

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
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Caulfield, Victoria, Australia, 3162
        • Caulfield Hospital
      • Heidelberg West, Victoria, Australia, 3081
        • Austin Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Melbourne, Victoria, Australia, 3000
        • Royal Melbourne Hospital
  • France
      • Paris, France, 75013
        • Groupe Hospitalier Pitie-Salpetriere
    • Bas Rhin
      • Strasbourg Cedex, Bas Rhin, France, 67098
        • CHU Strasbourg - Hopital Hautepierre
    • Gironde
      • Bordeaux Cedex, Gironde, France, 33076
        • Groupe Hospitalier Pellegrin - Hôpital Pellegrin
    • Haute Garonne
      • Toulouse Cedex 9, Haute Garonne, France, 31059
        • Hôpital La Grave
    • Herault
      • Montpellier, Herault, France, 34295
        • Hopital Gui de Chauliac
    • Ille Et Vilaine
      • Rennes cedex 2, Ille Et Vilaine, France, 35033
        • Chu Rennes - Pontchaillou
    • Loire Atlantique
      • Nantes cedex 1, Loire Atlantique, France, 44093
        • CHU Nantes - Hopital Nord Laënnec
    • Paris
      • Paris cedex 10, Paris, France, 75010
        • Hôpital Lariboisière
    • Rhone
      • Villeurbanne, Rhone, France, 69100
        • Hôpital des Chapennes
  • Germany
      • Berlin, Germany, 13125
        • Charite - Campus Berlin Buch, Experimental and Clinical Research Center (ECRC)
    • Baden Wuertemberg
      • Böblingen, Baden Wuertemberg, Germany, 71034
        • Studienzentrum fur Neurologie und Psychiatrie
    • Baden Wuerttemberg
      • Mannheim, Baden Wuerttemberg, Germany, 68165
        • ISPG - Institut fuer Studien zur Psychischen Gesundheit
      • Ulm, Baden Wuerttemberg, Germany, 89081
        • Universitaetsklinikum Ulm
    • Bayern
      • Muenchen, Bayern, Germany, 81377
        • Institut fuer Schlaganfall- und Demenzforschung (ISD)
    • Hessen
      • Frankfurt, Hessen, Germany, 60528
        • Klinikum der Johann Wolfgang Goethe-Universitaet
    • Nordrhein Westfalen
      • Bonn, Nordrhein Westfalen, Germany, 53105
        • Universitaetsklinikum Bonn AoeR
    • Thueringen
      • Altenburg, Thueringen, Germany, 04600
        • Klinikum Altenburger Land GmbH
  • Italy
      • Brescia, Italy, 25125
        • IRCCS Centro San Giovanni di Dio Fatebenefratelli
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Palermo, Italy, 90127
        • Azienda Ospedaliero Universitaria Policlinico Paolo
      • Roma, Italy, 00185
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza
      • Vicenza, Italy, 36100
        • ULSS 6 Vicenza
  • Japan
    • Aichi-Ken
      • Obu-shi, Aichi-Ken, Japan, 474-8511
        • Research Site
    • Chiba-Ken
      • Chiba-shi, Chiba-Ken, Japan, 263-0043
        • Research Site
    • Kanagawa-Ken
      • Kawasaki-shi, Kanagawa-Ken, Japan, 213-8507
        • Research Site
    • Kyoto-Fu
      • Kyoto-shi, Kyoto-Fu, Japan, 600-8558
        • Research Site
    • Okayama-Ken
      • Kurashiki-shi, Okayama-Ken, Japan, 710-0813
        • Research Site
    • Osaka-Fu
      • Suita-shi, Osaka-Fu, Japan, 565-0871
        • Research Site
  • Poland
      • Bydgoszcz, Poland, 85-023
        • PALLMED Sp. z o.o.
      • Lublin, Poland, 20-954
        • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
      • Sopot, Poland, 81-855
        • Centrum Medyczne SENIOR
      • Warszawa, Poland, 01-697
        • Centrum Medyczne NeuroProtect
      • Warszawa, Poland, 03-242
        • Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 8028
        • Fundacio ACE
      • Lleida, Spain, 25198
        • Hospital de Santa Maria
      • Madrid, Spain, 28006
        • Complejo Hospitalario Ruber Juan Bravo
      • Sevilla, Spain, 41009
        • Hospital Victoria Eugenia
      • Valencia, Spain, 46026
        • Hospital Universitari I Politecnic La Fe
    • Vizcaya
      • Getxo, Vizcaya, Spain, 48993
        • CAE Oroitu
  • Sweden
      • Malmo, Sweden, 212 24
        • Skanes universitetssjukhus
      • Molndal, Sweden, 43180
        • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
      • Stockholm, Sweden, 141 86
        • Karolinska Universitetssjukhuset, Huddinge
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer's Institute
      • Phoenix, Arizona, United States, 85013
        • Dignity Health
      • Phoenix, Arizona, United States, 85004
        • Xenoscience Inc
      • Sun City, Arizona, United States, 85351
        • Banner Sun Health Research Institute
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center, Inc.
      • Carlsbad, California, United States, 92011
        • The Research Center of Southern California
      • Fremont, California, United States, 94538
        • Positron Research International
      • Fresno, California, United States, 93710
        • Neuropain Medical Center
      • Hanford, California, United States, 93230
        • V Royter, MD, APMC
      • Irvine, California, United States, 92614
        • Irvine Center for Clinical Research, Inc.
      • Lancaster, California, United States, 93534
        • Research Center for Clinical Studies West
      • Los Angeles, California, United States, 90095
        • Mary S. Easton Center for Alzheimer's Disease Research, UCLA
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
      • Palo Alto, California, United States, 94304
        • Stanford Hospital and Clinics
      • San Diego, California, United States, 92103
        • Pacific Research Network, Inc
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
      • New Haven, Connecticut, United States, 06510
        • Invicro
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research Institute
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • Fort Myers, Florida, United States, 33912
        • Neuropsychiatric Research Center of Southwest Florida
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Orlando, Florida, United States, 32806
        • Synexus Clinical Research US, Inc. - Orlando
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Stuart, Florida, United States, 34997
        • Brain Matters Research
      • Tampa, Florida, United States, 33609
        • Axiom Clinical Research of Florida
      • Tampa, Florida, United States, 33614
        • Olympian Clinical Research
      • The Villages, Florida, United States, 32162
        • Synexus Clinical Research US, Inc. - The Villages
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University Cognitive Neurology Clinic & ADRC
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts
      • Boston, Massachusetts, United States, 02115 5804
        • Brigham and Women's Hospital Department of Neurology
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices & Research
      • Newton, Massachusetts, United States, 02459
        • Boston Center for Memory
      • Plymouth, Massachusetts, United States, 02360
        • Donald S. Marks, M.D., P.C.
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Cleveland Clinic Lou Ruvo Center for Brain Health
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research
    • New Jersey
      • Springfield, New Jersey, United States, 07081
        • The Cognitive Research Center of New Jersey
      • Toms River, New Jersey, United States, 08755
        • Advanced Memory Enhancement Center of NJ
    • New York
      • New York, New York, United States, 10016
        • New York University Medical Center PRIME
      • Rochester, New York, United States, 14620
        • AD-CARE, University of Rochester
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Rhode Island Mood & Memory Research Institute
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Neurology Clinic, PC
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Vermont
      • Bennington, Vermont, United States, 05201
        • The Memory Clinic, Inc.
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Cognition Health

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

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Must have a gradual and progressive change in memory function over more than 6 months.
  • Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD and must have
  • Objective evidence of cognitive impairment at Screening
  • Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD
  • Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive)
  • CDR Memory Box score of ≥0.5
  • Must consent to apolipoprotein E (ApoE) genotyping
  • Must have 1 informant/study partner
  • Must have amyloid beta positivity confirmed at Screening

Key Exclusion Criteria:

  • Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns
  • Clinically significant, unstable psychiatric illness
  • Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
  • Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
  • History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit 1
  • Indication of impaired renal or liver function
  • Alcohol or substance abuse in past 1 year
  • Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period
  • Use of allowed medications for chronic conditions at doses that have not been stable for at least 4 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1, or use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1.
  • Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participants at higher risk for adverse events (AEs), or impair the participant's ability to perform cognitive testing or complete study procedures.
  • Contraindications to study procedures

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
Intervention / Treatment
Experimental: Low-dose BIIB092
Intravenous (IV) infusion once every 4 weeks OR once every 12 weeks and placebo at the other 4-week dosing visits to maintain the treatment blind.
Drug: BIIB092
Administered as specified in treatment arm.
Other Names:
  • Formally known as BMS 986168
Experimental: Medium-dose BIIB092
Intravenous (IV) infusion once every 4 weeks.
Drug: BIIB092
Administered as specified in treatment arm.
Other Names:
  • Formally known as BMS 986168
Experimental: High-dose BIIB092
Intravenous (IV) infusion once every 4 weeks.
Drug: BIIB092
Administered as specified in treatment arm.
Other Names:
  • Formally known as BMS 986168
Placebo Comparator: Placebo
Intravenous (IV) infusion once every 4 weeks.
Drug: Placebo
Administered as specified in treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)
AE is any untoward medical occurrence in participant or clinical investigation participant administered pharmaceutical product and that does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product, whether or not related to medicinal (investigational) product. SAE is any untoward medical occurrence that at any dose, results in death; in view of investigator places participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; is medically important event. Participants who completed treatment period in PC period and did not enter LTE period were to be assessed at Week 90 (14 weeks after end of treatment) as safety follow-up.
Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)
LTE Period: Percentage of Participants With AEs and SAEs
Time Frame: From Week 80 to Week 173
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.
From Week 80 to Week 173

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score
Time Frame: Baseline, Week 78
The CDR-SB is a validated clinical assessment of global function in participants with AD. The CDR is comprised of 6 domains: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB is the sum of the scores for these 6 domains. Impairment is scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or "box scores", can be added together to give the CDR-SB score which ranges from 0 (none) to 18 (severe impairment).
Baseline, Week 78
PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum
Time Frame: Baseline up to Week 76
Baseline up to Week 76

Collaborators and Investigators

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

Sponsor

Biogen

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)

May 3, 2018

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 24, 2017

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 251AD201
  • 2017-002901-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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