TANGO

TerminatedPhase 2Results posted

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

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

Lead sponsor

Biogen

Asset

Gosuranemab

Listed sites

101

Recruiting sites

Enrollment

654

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•MCI due to AD•Amyloid biomarker required•MMSE 22-30•Study partner/caregiver required

Primary endpoints

•PC Period•LTE Period

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2017-002901-37

Org study ID251AD201

NCT IDNCT03352557

Timeline

Milestones

Study first posted2017-11-24actual

Study start2018-05-03actual

Primary completion2021-08-30actual

Study completion2021-08-30actual

Last update posted2022-11-08actual

Results first posted2022-11-08actual

Assets

Drug assets

Gosuranemab

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion 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

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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Global cognition

Other (unclassified)

Global cognition

2 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline, Week 78

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 78

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
PC Period: PlaceboBaselinen=214 Participants	3.07	1.467
Change at Week 78n=170 Participants	1.71	2.376
PC Period: BIIB092 Low DoseBaselinen=116 Participants	2.92	1.620
Change at Week 78n=98 Participants	2.10	2.375
PC Period: BIIB092 600 mg/4 WeekBaselinen=106 Participants	3.24	1.557
Change at Week 78n=91 Participants	2.23	2.987
PC Period: BIIB092 2000 mg/4 WeekBaselinen=214 Participants	3.04	1.378
Change at Week 78n=174 Participants	1.76	2.038

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

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)

threshold achievement, event

Primary/protocol endpoint

LTE Period: Percentage of Participants With AEs and SAEs

Time frame:From Week 80 to Week 173

threshold achievement, event

Primary/registry result

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)

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	Reported bounds
PC Period: PlaceboAEsn=214 Participants	84.6	-
SAEsn=214 Participants	12.1	-
PC Period: BIIB092 125 mg/4 WeekAEsn=58 Participants	86.2	-
SAEsn=58 Participants	10.3	-
PC Period: BIIB092 375 mg/12 WeekAEsn=58 Participants	82.8	-
SAEsn=58 Participants	10.3	-
PC Period: BIIB092 600 mg/4 WeekAEsn=106 Participants	88.7	-
SAEsn=106 Participants	12.3	-
PC Period: BIIB092 2000 mg/4 WeekAEsn=214 Participants	88.3	-
SAEsn=214 Participants	11.7	-

Primary/registry result

LTE Period: Percentage of Participants With AEs and SAEs

Time frame:From Week 80 to Week 173

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	Reported bounds
LTE Period: BIIB092 125 mg/4 WeekAEsn=45 Participants	68.9	-
SAEsn=45 Participants	11.1	-
LTE Period: BIIB092 375 mg/12 WeekAEsn=49 Participants	55.1	-
SAEsn=49 Participants	2.0	-
LTE Period: BIIB092 600 mg/4 WeekAEsn=89 Participants	58.4	-
SAEsn=89 Participants	10.1	-
LTE Period: BIIB092 2000 mg/4 Week - Early StartAEsn=168 Participants	61.3	-
SAEsn=168 Participants	6.0	-
LTE Period: BIIB092 2000 mg/4 Week - Late StartAEsn=165 Participants	60.0	-
SAEsn=165 Participants	7.9	-

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline up to Week 76

threshold achievement, improvement

Secondary/registry result/low confidence

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

Time frame:Baseline up to Week 76

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	Reported bounds
PC Period: Placebon=211 Participants	1.9	-
PC Period: BIIB092 125 mg/4 Weekn=57 Participants	0	-
PC Period: BIIB092 375 mg/12 Weekn=57 Participants	0	-
PC Period: BIIB092 600 mg/4 Weekn=105 Participants	1.0	-
PC Period: BIIB092 2000 mg/4 Weekn=212 Participants	0	-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
PMID38012285via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.