Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    tango | Belmont, Massachusetts, U.S.
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03352557
Recruitment Status : Active, not recruiting
First Posted : November 24, 2017
Last Update Posted : February 7, 2020
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

Layout table for study information
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
Estimated Primary Completion Date : March 26, 2024
Estimated Study Completion Date : March 26, 2024

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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Hide Hide 105 study locations
Layout table for location information
United States, Alabama
Research Site
Birmingham, Alabama, United States, 35205
United States, Arizona
Xenoscience Inc
Phoenix, Arizona, United States, 85004
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Research Site
Phoenix, Arizona, United States, 85013
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, California
Research Site
Anaheim, California, United States, 92805
Research Site
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
Research Site
Irvine, California, United States, 92614
Research Site
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
Research Site
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
Associated Neurologists of Southern Connecticut, P.C.
Fairfield, Connecticut, United States, 06824
Research Site
New Haven, Connecticut, United States, 06510
Research Site
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
Bioclinica Melbourne
Orlando, Florida, United States, 32806
Research Site
Port Orange, Florida, United States, 32127
Research Site
Stuart, Florida, United States, 34997
Axiom Clinical Research of Florida
Tampa, Florida, United States, 33609
Research Site
Tampa, Florida, United States, 33615
Research Site
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
Research Site
Boston, Massachusetts, United States, 02111
Research Site
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
Research Site
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
Research Site
New York, New York, United States, 10016
AD-CARE, University of Rochester
Rochester, New York, United States, 14620
Research Site
Staten Island, New York, United States, 10312
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Rhode Island
Research Site
East Providence, Rhode Island, United States, 02915
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States, 02915
Research Site
Providence, Rhode Island, United States, 02903
Research Site
Providence, Rhode Island, United States, 02906
United States, Tennessee
Neurology Clinic, PC
Cordova, Tennessee, United States, 38018
United States, Texas
Baylor Colledge 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
Research Site
Fairfax, Virginia, United States, 22031
Australia, Victoria
Research Site
Box Hill, Victoria, Australia, 3128
Research Site
Caulfield, Victoria, Australia, 3162
Research Site
Heidelberg West, Victoria, Australia, 3081
Research Site
Melbourne, Victoria, Australia, 3004
Research Site
Parkville, Victoria, Australia, 3050
France
Research Site
Strasbourg Cedex, Bas Rhin, France, 67000
Research Site
Bordeaux Cedex, Gironde, France, 33076
Research Site
Toulouse Cedex 9, Haute Garonne, France, 31059
Research Site
Montpellier, Herault, France, 34295
Research Site
Rennes cedex 2, Ille Et Vilaine, France, 35033
Research Site
Nantes cedex 1, Loire Atlantique, France, 44093
Research Site
Villeurbanne, Rhone, France, 69100
Research Site
Paris, France, 75010
Research Site
Paris, France, 75013
Germany
Research Site
Böblingen, Baden Wuertemberg, Germany, 71034
Research Site
Mannheim, Baden Wuerttemberg, Germany, 68165
Research Site
Ulm, Baden Wuerttemberg, Germany, 89081
Research Site
Muenchen, Bayern, Germany, 81377
Research Site
Frankfurt, Hessen, Germany, 60528
Research Site
Bonn, Nordrhein Westfalen, Germany, 53127
Research Site
Altenburg, Thueringen, Germany, 04600
Research Site
Berlin, Germany, 13125
Italy
Research Site
Brescia, Italy, 25125
Research Site
Milano, Italy, 20132
Research Site
Padova, Italy, 35128
Research Site
Palermo, Italy, 90127
Research Site
Roma, Italy, 00185
Research Site
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
Research Site
Shinjuku-ku, Tokyo-To, Japan, 160-0023
Poland
Research Site
Bydgoszcz, Poland, 85-023
Research Site
Lublin, Poland, 20-954
Research Site
Sopot, Poland, 81-855
Research Site
Warszawa, Poland, 01-697
Research Site
Warszawa, Poland, 03-242
Spain
Research Site
Getxo, Vizcaya, Spain, 48993
Research Site
Barcelona, Spain, 08036
Research Site
Barcelona, Spain, 08041
Research Site
Barcelona, Spain, 8028
Research Site
Lleida, Spain, 25198
Research Site
Madrid, Spain, 28006
Research Site
Sevilla, Spain, 41009
Research Site
Valencia, Spain, 46026
Sweden
Research Site
Malmo, Sweden, 212 24
Research Site
Molndal, Sweden, 43180
Research Site
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Biogen
Investigators
Layout table for investigator information
Study Director: Medical Director Biogen
Additional Information:
Layout table for additonal information
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: February 7, 2020
Last Verified: February 2020

Layout table for additional information
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:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders