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

Sponsor
Biogen (Industry)
Overall Status
Terminated
CT.gov ID
NCT03352557
Collaborator
(none)
654
101
4
39.9
6.5
0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
654 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
May 3, 2018
Actual Primary Completion Date :
Aug 30, 2021
Actual Study Completion Date :
Aug 30, 2021

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Up to Week 238]

      AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.

    Secondary Outcome Measures

    1. Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) [From Baseline to Week 78]

      The CDR-SB is a validated clinical assessment of global function in participants with AD. 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 which ranges from 0 to 18 (severe impairment).

    2. Percentage of Participants With Anti-BIIB092 Antibodies in Serum Over Time up to Week 90 [From Baseline up to Week 90]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Medical Director, Biogen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT03352557
    Other Study ID Numbers:
    • 251AD201
    • 2017-002901-37
    First Posted:
    Nov 24, 2017
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Biogen
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 26, 2022