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Trial record 2 of 2 for:    TANGO | Alzheimer Disease

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

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ClinicalTrials.gov Identifier: NCT03352557
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
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. 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. To evaluate the immunogenicity of BIIB092 after multiple doses 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 528 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 : July 9, 2021
Estimated Study Completion Date : July 9, 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 76 ]
    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


Contacts
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

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Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Additional Information:
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03352557     History of Changes
Other Study ID Numbers: 251AD201
2017-002901-37 ( EudraCT Number )
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018

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:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Cognitive Dysfunction
Dementia
Tauopathies