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

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ClinicalTrials.gov Identifier: NCT03352557
Recruitment Status : Terminated (The study (NCT03352557) was terminated based on lack of efficacy following the placebo-controlled period readout.)
First Posted : November 24, 2017
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Biogen

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
Alzheimer's Disease Drug: BIIB092 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : August 30, 2021
Actual Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Formally known as BMS 986168

Placebo Comparator: Placebo
Intravenous (IV) infusion once every 4 weeks.
Drug: Placebo
Administered as specified in treatment arm.




Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: From Baseline up to Week 90 ]


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352557


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
United States, Arizona
Xenoscience Inc
Phoenix, Arizona, United States, 85004
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Dignity Health
Phoenix, Arizona, United States, 85013
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, California
Advanced Research Center, Inc.
Anaheim, California, United States, 92805
The Research Center of Southern California
Carlsbad, California, United States, 92011
Positron Research International
Fremont, California, United States, 94538
Neuropain Medical Center
Fresno, California, United States, 93710
V Royter, MD, APMC
Hanford, California, United States, 93230
Irvine Center for Clinical Research, Inc.
Irvine, California, United States, 92614
Research Center for Clinical Studies West
Lancaster, California, United States, 93534
Mary S. Easton Center for Alzheimer's Disease Research, UCLA
Los Angeles, California, United States, 90095
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Stanford Hospital and Clinics
Palo Alto, California, United States, 94304
Pacific Research Network, Inc
San Diego, California, United States, 92103
Syrentis Clinical Research
Santa Ana, California, United States, 92705
United States, Connecticut
Invicro
New Haven, Connecticut, United States, 06510
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
JEM Research Institute
Atlantis, Florida, United States, 33462
Brain Matters Research
Delray Beach, Florida, United States, 33445
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Renstar Medical Research
Ocala, Florida, United States, 34471
Synexus Clinical Research US, Inc. - Orlando
Orlando, Florida, United States, 32806
Progressive Medical Research
Port Orange, Florida, United States, 32127
Brain Matters Research
Stuart, Florida, United States, 34997
Axiom Clinical Research of Florida
Tampa, Florida, United States, 33609
Olympian Clinical Research
Tampa, Florida, United States, 33614
Synexus Clinical Research US, Inc. - The Villages
The Villages, Florida, United States, 32162
United States, Georgia
Emory University Cognitive Neurology Clinic & ADRC
Atlanta, Georgia, United States, 30329
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Tufts
Boston, Massachusetts, United States, 02111
Brigham and Women's Hospital Department of Neurology
Boston, Massachusetts, United States, 02115 5804
ActivMed Practices & Research
Methuen, Massachusetts, United States, 01844
Boston Center for Memory
Newton, Massachusetts, United States, 02459
Donald S. Marks, M.D., P.C.
Plymouth, Massachusetts, United States, 02360
United States, Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
Las Vegas Medical Research
Las Vegas, Nevada, United States, 89113
United States, New Jersey
The Cognitive Research Center of New Jersey
Springfield, New Jersey, United States, 07081
Advanced Memory Enhancement Center of NJ
Toms River, New Jersey, United States, 08755
United States, New York
New York University Medical Center PRIME
New York, New York, United States, 10016
AD-CARE, University of Rochester
Rochester, New York, United States, 14620
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Rhode Island
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States, 02915
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
Neurology Clinic, PC
Cordova, Tennessee, United States, 38018
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Vermont
The Memory Clinic, Inc.
Bennington, Vermont, United States, 05201
United States, Virginia
Cognition Health
Fairfax, Virginia, United States, 22031
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Caulfield Hospital
Caulfield, Victoria, Australia, 3162
Austin Hospital
Heidelberg West, Victoria, Australia, 3081
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3000
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
France
CHU Strasbourg - Hôpital Hautepierre
Strasbourg Cedex, Bas Rhin, France, 67098
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Bordeaux Cedex, Gironde, France, 33076
Hôpital La Grave
Toulouse Cedex 9, Haute Garonne, France, 31059
Hopital Gui de Chauliac
Montpellier, Herault, France, 34295
CHU Rennes - Pontchaillou
Rennes cedex 2, Ille Et Vilaine, France, 35033
CHU Nantes - Hopital Nord Laënnec
Nantes cedex 1, Loire Atlantique, France, 44093
Hôpital Lariboisière
Paris cedex 10, Paris, France, 75010
Hôpital des Chapennes
Villeurbanne, Rhone, France, 69100
Groupe Hospitalier Pitie-Salpetriere
Paris, France, 75013
Germany
Studienzentrum fur Neurologie und Psychiatrie
Böblingen, Baden Wuertemberg, Germany, 71034
ISPG - Institut fuer Studien zur Psychischen Gesundheit
Mannheim, Baden Wuerttemberg, Germany, 68165
Universitaetsklinikum Ulm
Ulm, Baden Wuerttemberg, Germany, 89081
Institut fuer Schlaganfall- und Demenzforschung (ISD)
Muenchen, Bayern, Germany, 81377
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, Hessen, Germany, 60528
Universitaetsklinikum Bonn AoeR
Bonn, Nordrhein Westfalen, Germany, 53105
Klinikum Altenburger Land GmbH
Altenburg, Thueringen, Germany, 04600
Charite - Campus Berlin Buch, Experimental and Clinical Research Center (ECRC)
Berlin, Germany, 13125
Italy
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy, 25125
Ospedale San Raffaele
Milano, Italy, 20132
Azienda Ospedaliero Universitaria Policlinico Paolo
Palermo, Italy, 90127
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, Italy, 00185
ULSS 6 Vicenza
Vicenza, Italy, 36100
Japan
Research Site
Obu-shi, Aichi-Ken, Japan, 474-8511
Research Site
Chiba-shi, Chiba-Ken, Japan, 263-0043
Research Site
Kawasaki-shi, Kanagawa-Ken, Japan, 213-8507
Research Site
Kyoto-shi, Kyoto-Fu, Japan, 600-8558
Research Site
Kurashiki-shi, Okayama-Ken, Japan, 710-0813
Research Site
Suita-shi, Osaka-Fu, Japan, 565-0871
Poland
PALLMED Sp. z o.o.
Bydgoszcz, Poland, 85-023
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Poland, 20-954
Centrum Medyczne Senior
Sopot, Poland, 81-855
Centrum Medyczne NeuroProtect
Warszawa, Poland, 01-697
Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo
Warszawa, Poland, 03-242
Spain
CAE Oroitu
Getxo, Vizcaya, Spain, 48993
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Fundacio ACE
Barcelona, Spain, 8028
Hospital de Santa Maria
Lleida, Spain, 25198
Complejo Hospitalario Ruber Juan Bravo
Madrid, Spain, 28006
Hospital Victoria Eugenia
Sevilla, Spain, 41009
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Sweden
Skånes Universitetssjukhus
Malmo, Sweden, 212 24
Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
Molndal, Sweden, 43180
Karolinska Universitetssjukhuset, Huddinge
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03352557    
Other Study ID Numbers: 251AD201
2017-002901-37 ( EudraCT Number )
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biogen:
Mild cognitive impairment
Alzheimer's disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders