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Alzheimer's DiseasePhase 2TANGONCT03352557

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

A Phase 2 study testing BIIB092 in people with Alzheimer's Disease, run by Biogen at 101 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
BIIB092
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
654 participants
Where
101 sitesin 9 countries
Study dates
3 May 2018to 30 Aug 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Must consent to apolipoprotein E (ApoE) genotyping
  • Must have 1 informant/study partner
  • Must have amyloid beta positivity confirmed at Screening

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

101 sites in 9 countries.

101 sites in 9 countries

United States52 sites

  • Advanced Research Center, Inc.

    Anaheim, California, 92805

  • Emory University Cognitive Neurology Clinic & ADRC

    Atlanta, Georgia, 30329

  • JEM Research Institute

    Atlantis, Florida, 33462

  • McLean Hospital

    Belmont, Massachusetts, 02478

  • The Memory Clinic, Inc.

    Bennington, Vermont, 05201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

  • Tufts

    Boston, Massachusetts, 02111

  • Brigham and Women's Hospital Department of Neurology

    Boston, Massachusetts, 02115 5804

  • The Research Center of Southern California

    Carlsbad, California, 92011

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Neurology Clinic, PC

    Cordova, Tennessee, 38018

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02915

  • Cognition Health

    Fairfax, Virginia, 22031

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Positron Research International

    Fremont, California, 94538

  • Neuropain Medical Center

    Fresno, California, 93710

  • V Royter, MD, APMC

    Hanford, California, 93230

  • Baylor College of Medicine

    Houston, Texas, 77030

  • The Methodist Hospital

    Houston, Texas, 77030

  • Irvine Center for Clinical Research, Inc.

    Irvine, California, 92614

  • Research Center for Clinical Studies West

    Lancaster, California, 93534

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Mary S. Easton Center for Alzheimer's Disease Research, UCLA

    Los Angeles, California, 90095

  • ActivMed Practices & Research

    Methuen, Massachusetts, 01844

  • Invicro

    New Haven, Connecticut, 06510

  • Yale University School Of Medicine

    New Haven, Connecticut, 06520

  • New York University Medical Center PRIME

    New York, New York, 10016

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Synexus Clinical Research US, Inc. - Orlando

    Orlando, Florida, 32806

  • Stanford Hospital and Clinics

    Palo Alto, California, 94304

  • Xenoscience Inc

    Phoenix, Arizona, 85004

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Dignity Health

    Phoenix, Arizona, 85013

  • Donald S. Marks, M.D., P.C.

    Plymouth, Massachusetts, 02360

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Butler Hospital

    Providence, Rhode Island, 02906

  • AD-CARE, University of Rochester

    Rochester, New York, 14620

  • Pacific Research Network, Inc

    San Diego, California, 92103

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • The Cognitive Research Center of New Jersey

    Springfield, New Jersey, 07081

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Brain Matters Research

    Stuart, Florida, 34997

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Olympian Clinical Research

    Tampa, Florida, 33614

  • Synexus Clinical Research US, Inc. - The Villages

    The Villages, Florida, 32162

  • Advanced Memory Enhancement Center of NJ

    Toms River, New Jersey, 08755

Other trials in United States

France9 sites

  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin

    Bordeaux, Gironde, 33076

  • Hopital Gui de Chauliac

    Montpellier, Herault, 34295

  • CHU Nantes - Hopital Nord Laënnec

    Nantes, Loire Atlantique, 44093

  • Hôpital Lariboisière

    Paris, Paris, 75010

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013

  • CHU Rennes - Pontchaillou

    Rennes, Ille Et Vilaine, 35033

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg, Bas Rhin, 67098

  • Hôpital La Grave

    Toulouse, Haute Garonne, 31059

  • Hôpital des Chapennes

    Villeurbanne, Rhone, 69100

Other trials in France

Germany8 sites

  • Klinikum Altenburger Land GmbH

    Altenburg, Thuringia, 04600

  • Charite - Campus Berlin Buch, Experimental and Clinical Research Center (ECRC)

    Berlin, 13125

  • Studienzentrum fur Neurologie und Psychiatrie

    Böblingen, Baden-Wurttemberg, 71034

  • Universitaetsklinikum Bonn AoeR

    Bonn, North Rhine-Westphalia, 53105

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt am Main, Hesse, 60528

  • ISPG - Institut fuer Studien zur Psychischen Gesundheit

    Mannheim, Baden-Wurttemberg, 68165

  • Institut fuer Schlaganfall- und Demenzforschung (ISD)

    Munich, Bavaria, 81377

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Spain8 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Fundacio ACE

    Barcelona, 8028

  • CAE Oroitu

    Getxo, Vizcaya, 48993

  • Hospital de Santa Maria

    Lleida, 25198

  • Complejo Hospitalario Ruber Juan Bravo

    Madrid, 28006

  • Hospital Victoria Eugenia

    Seville, 41009

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Japan6 sites

  • Research Site

    Chiba, Chiba, 263-0043

  • Research Site

    Kawasaki-shi, Kanagawa, 213-8507

  • Research Site

    Kurashiki-shi, Okayama-ken, 710-0813

  • Research Site

    Kyoto, Kyoto, 600-8558

  • Research Site

    Obu-shi, Aichi-ken, 474-8511

  • Research Site

    Suita-shi, Osaka, 565-0871

Other trials in Japan

Australia5 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Caulfield Hospital

    Caulfield, Victoria, 3162

  • Austin Hospital

    Heidelberg West, Victoria, 3081

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3000

  • The Alfred Hospital

    Melbourne, Victoria, 3004

Other trials in Australia

Italy5 sites

  • IRCCS Centro San Giovanni di Dio Fatebenefratelli

    Brescia, 25125

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliero Universitaria Policlinico Paolo

    Palermo, 90127

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

    Roma, 00185

  • ULSS 6 Vicenza

    Vicenza, 36100

Other trials in Italy

Poland5 sites

  • PALLMED Sp. z o.o.

    Bydgoszcz, 85-023

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-954

  • Centrum Medyczne Senior

    Sopot, 81-855

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-697

  • Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo

    Warsaw, 03-242

Other trials in Poland

Sweden3 sites

  • Skånes Universitetssjukhus

    Malmö, 212 24

  • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

    Mölndal, 43180

  • Karolinska Universitetssjukhuset, Huddinge

    Stockholm, 141 86

Other trials in Sweden

About this study

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

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.

Being tested
BIIB092, Placebo
Keywords
Mild cognitive impairment, Alzheimer's disease
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIIB092Drug

    Also called Formally known as BMS 986168

    Administered as specified in treatment arm.

  • PlaceboDrug

    Administered as specified in treatment arm.

Study groups in NCT03352557
Study groupRoleWhat they receive
Low-dose BIIB092ExperimentalIntravenous (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.
Receives: Drug: BIIB092
Medium-dose BIIB092ExperimentalIntravenous (IV) infusion once every 4 weeks.
Receives: Drug: BIIB092
High-dose BIIB092ExperimentalIntravenous (IV) infusion once every 4 weeks.
Receives: Drug: BIIB092
PlaceboPlacebo comparatorIntravenous (IV) infusion once every 4 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    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.

    Measured: Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)

  2. LTE Period: Percentage of Participants With AEs and SAEs

    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.

    Measured: From Week 80 to Week 173

Secondary outcomes (2)

  1. PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score

    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).

    Measured: Baseline, Week 78

  2. PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum

    Measured: Baseline up to Week 76

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2017
  2. Study start3 May 2018
  3. Primary completion30 Aug 2021
  4. Study completion30 Aug 2021

Why it stopped: The study (NCT03352557) was terminated based on lack of efficacy following the placebo-controlled period readout.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
654 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03352557
Sponsor's protocol ID
251AD201
Other IDs
2017-002901-37, 2017
Acronym
TANGO
Status last verified
Oct 2022
First submitted
21 Nov 2017
Last updated
8 Nov 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

Publications

  • Shulman M, Kong J, O'Gorman J, Ratti E, Rajagovindan R, Viollet L, Huang E, Sharma S, Racine AM, Czerkowicz J, Graham D, Li Y, Hering H, Haeberlein SB. TANGO: a placebo-controlled randomized phase 2 study of efficacy and safety of the anti-tau monoclonal antibody gosuranemab in early Alzheimer's disease. Nat Aging. 2023 Dec;3(12):1591-1601. doi: 10.1038/s43587-023-00523-w. Epub 2023 Nov 27.

    PubMed 38012285

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIIB092 in people with Alzheimer's Disease, run by Biogen at 101 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States, France, Germany, Spain, Japan and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03352557, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.

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