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BIIB092 for Early Alzheimer's Disease (TANGO)

Active, not recruiting

The study will evaluate BIIB092, a monoclonal antibody, in people with mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 80 Years All No
May 3, 2018
June 30, 2024
528

  • Gradual, progressive change in memory function during more than 6 months
  • MCI due to Alzheimer's disease or mild Alzheimer's disease
  • Objective evidence of cognitive impairment, as shown by Clinical Dementia Rating (CDR) Scale score of 0.5 for MCI or 0.5 or 1 for mild Alzheimer's, Mini-Mental State Examination score of 22-30 (inclusive), and CDR Memory Box score of  0.5
  • Consent to apolipoprotein E (ApoE) genotyping
  • Informant/study partner
  • Beta-amyloid positivity confirmed at screening

  • Any medical or neurological/neurodegenerative condition other than Alzheimer's 
  • Clinically significant, unstable psychiatric illness
  • Stroke, mini-stroke, or unexplained loss of consciousness during the past year
  • Brain hemorrhage, bleeding disorder, or cerebrovascular abnormalities
  • History of unstable angina, heart attack, chronic heart failure, or clinically significant conduction abnormalities during the past year
  • Impaired renal or liver function
  • Alcohol or substance abuse during the past year
  • Significant illness or infection during the past year
  • Unstable medication dosing for chronic conditions during the past 4 weeks
  • Unstable medication dosing for Alzheimer's disease during the past 8 weeks
  • Any medication use that may contribute to cognitive impairment or increase risk for adverse events

In this phase II clinical trial, participants will receive one of the following:

  • A low dose of BIIB092 every 4 weeks
  • A medium dose of BIIB092 every 4 weeks
  • A high dose of BIIB092 every 4 weeks
  • A placebo dose every 4 weeks
  • A low dose of BIIB092 every 12 weeks and a placebo dose at the other 4-week dosing visits

All doses will be given intravenously. Participants will be evaluated for dementia at the beginning of the study and at Week 78. Participants also will receive, through Week 90, physical exams, including electrocardiograms and blood tests. BIIB092 is a humanized monoclonal antibody that acts on tau, a protein in the brains of people with Alzheimer's disease and certain other neurodegenerative disorders.

Name City State Zip Status Primary Contact
Research Site
Birmingham Alabama 35205

Xenoscience Inc
Phoenix Arizona 85004

Banner Alzheimer's Institute
Phoenix Arizona 85006

Research Site
Phoenix Arizona 85013

Banner Sun Health Research Institute
Sun City Arizona 85351

Research Site
Anaheim California 92805

Research Site
Carlsbad California 92011

Positron Research International
Fremont California 94538

Neuropain Medical Center
Fresno California 93710

V Royter, MD, APMC
Hanford California 93230

Research Site
Irvine California 92614

Research Site
Lancaster California 93534

Mary S. Easton Center for Alzheimer's Disease Research, UCLA
Los Angeles California 90095

Hoag Memorial Hospital Presbyterian
Newport Beach California 92663

Research Site
Palo Alto California 94304

Pacific Research Network, Inc
San Diego California 92103

Syrentis Clinical Research
Santa Ana California 92705

Associated Neurologists of Southern Connecticut, P.C.
Fairfield Connecticut 06824

Research Site
New Haven Connecticut 06510

Research Site
New Haven Connecticut 06520

JEM Research Institute
Atlantis Florida 33462

Brain Matters Research
Delray Beach Florida 33445

Neuropsychiatric Research Center of Southwest Florida
Fort Myers Florida 33912

Renstar Medical Research
Ocala Florida 34471

Bioclinica Melbourne
Orlando Florida 32806

Research Site
Port Orange Florida 32127

Research Site
Stuart Florida 34997

Axiom Clinical Research of Florida
Tampa Florida 33609

Research Site
Tampa Florida 33615

Research Site
The Villages Florida 32162

Emory University Cognitive Neurology Clinic & ADRC
Atlanta Georgia 30329

McLean Hospital
Belmont Massachusetts 02478

Research Site
Boston Massachusetts 02111

Research Site
Boston Massachusetts 02115 5804

ActivMed Practices & Research
Methuen Massachusetts 01844

Boston Center for Memory
Newton Massachusetts 02459

Donald S. Marks, M.D., P.C.
Plymouth Massachusetts 02360

Research Site
Las Vegas Nevada 89106

Las Vegas Medical Research
Las Vegas Nevada 89113

The Cognitive Research Center of New Jersey
Springfield New Jersey 07081

Advanced Memory Enhancement Center of NJ
Toms River New Jersey 08755

Research Site
New York New York 10016

AD-CARE, University of Rochester
Rochester New York 14620

Research Site
Staten Island New York 10312

Cleveland Clinic
Cleveland Ohio 44195

Research Site
East Providence Rhode Island 02915

Rhode Island Mood & Memory Research Institute
East Providence Rhode Island 02915

Research Site
Providence Rhode Island 02903

Research Site
Providence Rhode Island 02906

Neurology Clinic, PC
Cordova Tennessee 38018

Baylor Colledge of Medicine
Houston Texas 77030

The Methodist Hospital
Houston Texas 77030

The Memory Clinic, Inc.
Bennington Vermont 05201

Research Site
Fairfax Virginia 22031

Biogen

Name Role Affiliation
Medical Director Study Director Biogen

Name Phone Email
U.S. Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com

NCT03352557

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