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

NCT03352557 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 251AD2012017-002901-37
• Study Type: interventional
• Target: 654
• Locations: 9 countries
• Sites: 101

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.

Conditions

Alzheimer's Disease

Keywords

Mild cognitive impairment; Alzheimer's disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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 Outcomes (2)

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

  Baseline, Week 78

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

  Baseline up to Week 76

Study Arms (4)

Low-dose BIIB092

EXPERIMENTAL

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

Medium-dose BIIB092

EXPERIMENTAL

Intravenous (IV) infusion once every 4 weeks.

Drug: BIIB092

High-dose BIIB092

EXPERIMENTAL

Intravenous (IV) infusion once every 4 weeks.

Drug: BIIB092

Placebo

PLACEBO COMPARATOR

Intravenous (IV) infusion once every 4 weeks.

Drug: Placebo

Interventions

BIIB092 DRUG

Administered as specified in treatment arm.

Also known as: Formally known as BMS 986168

High-dose BIIB092; Low-dose BIIB092; Medium-dose BIIB092

Placebo DRUG

Administered as specified in treatment arm.

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (101)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

Xenoscience Inc

Phoenix, Arizona, 85004, United States

Location

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Dignity Health

Phoenix, Arizona, 85013, United States

Location

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

Advanced Research Center, Inc.

Anaheim, California, 92805, United States

Location

The Research Center of Southern California

Carlsbad, California, 92011, United States

Location

Positron Research International

Fremont, California, 94538, United States

Location

Neuropain Medical Center

Fresno, California, 93710, United States

Location

V Royter, MD, APMC

Hanford, California, 93230, United States

Location

Irvine Center for Clinical Research, Inc.

Irvine, California, 92614, United States

Location

Research Center for Clinical Studies West

Lancaster, California, 93534, United States

Location

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

Los Angeles, California, 90095, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Stanford Hospital and Clinics

Palo Alto, California, 94304, United States

Location

Pacific Research Network, Inc

San Diego, California, 92103, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Invicro

New Haven, Connecticut, 06510, United States

Location

Yale University School Of Medicine

New Haven, Connecticut, 06520, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, 33912, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Synexus Clinical Research US, Inc. - Orlando

Orlando, Florida, 32806, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Brain Matters Research

Stuart, Florida, 34997, United States

Location

Axiom Clinical Research of Florida

Tampa, Florida, 33609, United States

Location

Olympian Clinical Research

Tampa, Florida, 33614, United States

Location

Synexus Clinical Research US, Inc. - The Villages

The Villages, Florida, 32162, United States

Location

Emory University Cognitive Neurology Clinic & ADRC

Atlanta, Georgia, 30329, United States

Location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Tufts

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital Department of Neurology

Boston, Massachusetts, 02115 5804, United States

Location

ActivMed Practices & Research

Methuen, Massachusetts, 01844, United States

Location

Boston Center for Memory

Newton, Massachusetts, 02459, United States

Location

Donald S. Marks, M.D., P.C.

Plymouth, Massachusetts, 02360, United States

Location

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, 89106, United States

Location

Las Vegas Medical Research

Las Vegas, Nevada, 89113, United States

Location

The Cognitive Research Center of New Jersey

Springfield, New Jersey, 07081, United States

Location

Advanced Memory Enhancement Center of NJ

Toms River, New Jersey, 08755, United States

Location

New York University Medical Center PRIME

New York, New York, 10016, United States

Location

AD-CARE, University of Rochester

Rochester, New York, 14620, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, 02915, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Neurology Clinic, PC

Cordova, Tennessee, 38018, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

The Memory Clinic, Inc.

Bennington, Vermont, 05201, United States

Location

Cognition Health

Fairfax, Virginia, 22031, United States

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Caulfield Hospital

Caulfield, Victoria, 3162, Australia

Location

Austin Hospital

Heidelberg West, Victoria, 3081, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3000, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

CHU Strasbourg - Hôpital Hautepierre

Strasbourg, Bas Rhin, 67098, France

Location

Groupe Hospitalier Pellegrin - Hôpital Pellegrin

Bordeaux, Gironde, 33076, France

Location

Hôpital La Grave

Toulouse, Haute Garonne, 31059, France

Location

Hopital Gui de Chauliac

Montpellier, Herault, 34295, France

Location

CHU Rennes - Pontchaillou

Rennes, Ille Et Vilaine, 35033, France

Location

CHU Nantes - Hopital Nord Laënnec

Nantes, Loire Atlantique, 44093, France

Location

Hôpital Lariboisière

Paris, Paris, 75010, France

Location

Hôpital des Chapennes

Villeurbanne, Rhone, 69100, France

Location

Groupe Hospitalier Pitie-Salpetriere

Paris, 75013, France

Location

Studienzentrum fur Neurologie und Psychiatrie

Böblingen, Baden-Wurttemberg, 71034, Germany

Location

ISPG - Institut fuer Studien zur Psychischen Gesundheit

Mannheim, Baden-Wurttemberg, 68165, Germany

Location

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Institut fuer Schlaganfall- und Demenzforschung (ISD)

Munich, Bavaria, 81377, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt am Main, Hesse, 60528, Germany

Location

Universitaetsklinikum Bonn AoeR

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Klinikum Altenburger Land GmbH

Altenburg, Thuringia, 04600, Germany

Location

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

Berlin, 13125, Germany

Location

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, 25125, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Paolo

Palermo, 90127, Italy

Location

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

Roma, 00185, Italy

Location

ULSS 6 Vicenza

Vicenza, 36100, Italy

Location

Research Site

Obu-shi, Aichi-ken, 474-8511, Japan

Location

Research Site

Chiba, Chiba, 263-0043, Japan

Location

Research Site

Kawasaki-shi, Kanagawa, 213-8507, Japan

Location

Research Site

Kyoto, Kyoto, 600-8558, Japan

Location

Research Site

Kurashiki-shi, Okayama-ken, 710-0813, Japan

Location

Research Site

Suita-shi, Osaka, 565-0871, Japan

Location

PALLMED Sp. z o.o.

Bydgoszcz, 85-023, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, 20-954, Poland

Location

Centrum Medyczne Senior

Sopot, 81-855, Poland

Location

Centrum Medyczne NeuroProtect

Warsaw, 01-697, Poland

Location

Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo

Warsaw, 03-242, Poland

Location

CAE Oroitu

Getxo, Vizcaya, 48993, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Fundacio ACE

Barcelona, 8028, Spain

Location

Hospital de Santa Maria

Lleida, 25198, Spain

Location

Complejo Hospitalario Ruber Juan Bravo

Madrid, 28006, Spain

Location

Hospital Victoria Eugenia

Seville, 41009, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Skånes Universitetssjukhus

Malmo, 212 24, Sweden

Location

Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

Mölndal, 43180, Sweden

Location

Karolinska Universitetssjukhuset, Huddinge

Stockholm, 141 86, Sweden

Location

Related Publications (1)

• 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.

  PMID: 38012285 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

gosuranemab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Limitations and Caveats

The study was terminated based on lack of efficacy following the placebo-controlled period readout.

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 24, 2017
• Study Start: May 3, 2018
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: November 8, 2022
• Results First Posted: November 8, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

SE (3); FR (9); DE (8); IT (5); ES (8); AU (5); JP (6); US (52); PL (5)