Evidence map›Paper›PMID 38012285›Full record

Trial reportNature aging2023

TANGO: a placebo-controlled randomized phase 2 study of efficacy and safety of the anti-tau monoclonal antibody gosuranemab in early Alzheimer's disease.

Melanie Shulman, Jessica Kong, John O'Gorman, Elena Ratti, Rajasimhan Rajagovindan, Louis Viollet, Ellen Huang, Sanjiv Sharma, Annie M Racine, Julie Czerkowicz and 4 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature aging, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial 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), which is not on this map. Cited by 61 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 1 pooled it
12.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03352557 phase2terminatednot on this map

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

TypeinterventionalSponsorBiogenRan2018 to 2021Enrolled654ConditionsAlzheimer's DiseaseArmsBIIB092, Placebo
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Pharmacodynamic effects of semorinemab on plasma and CSF biomarkers of Alzheimer's disease pathophysiology.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024
    Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Cross-disease protein aggregate interactions in neurodegeneration: from molecular mechanisms to therapeutic strategies.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Review
  10. Enhancing early Alzheimer's disease clinical trials through prognostic score covariate adjustment.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article
  11. Review
  12. Anatomy of a Setback: A Taxonomy of Clinical Trial Failures in Alzheimer's Disease and Strategic Lessons for the Future.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
    Review
  13. Review
  14. Article
  15. Neuropathological correlates of imaging in dementia with Lewy bodies.Journal of neural transmission (Vienna, Austria : 1996) · 2026
    Review
  16. Article
  17. Review
  18. Review
  19. Article
  20. Review

1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 1 institution in 2 countries.

Melanie ShulmanBiogen, Cambridge, MA, USA. melanie.shulman@biogen.com.ORCID 0009-0002-5550-9077
Jessica KongBiogen, Cambridge, MA, USA.
John O'GormanBiogen, Cambridge, MA, USA.
Elena RattiBiogen, Cambridge, MA, USA.
Rajasimhan RajagovindanBiogen, Cambridge, MA, USA.
Louis ViolletBiogen, Cambridge, MA, USA.
Ellen HuangBiogen, Cambridge, MA, USA.
Sanjiv SharmaCenExel AMRI, Toms River, NJ, USA.
Annie M RacineBiogen, Cambridge, MA, USA.
Julie CzerkowiczBiogen, Cambridge, MA, USA.
Danielle GrahamBiogen, Cambridge, MA, USA.
Yumeng LiBiogen, Cambridge, MA, USA.
Heike HeringBiogen, Cambridge, MA, USA.
Samantha Budd HaeberleinBiogen, Cambridge, MA, USA.ORCID 0000-0002-4824-646X
Biogen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In Alzheimer's disease, the spread of aberrantly phosphorylated tau is an important criterion in the Braak staging of disease severity and correlates with disease symptomatology. Here, we report the results of TANGO ( NCT03352557 ), a randomized, double-blind, placebo-controlled, parallel-group and multiple-dose long-term trial of gosuranemab-a monoclonal antibody to N-terminal tau-in patients with early Alzheimer's disease. The primary objective was to assess the safety and tolerability of gosuranemab compared to placebo. The secondary objectives were to assess the efficacy of multiple doses of gosuranemab in slowing cognitive and functional impairment (using the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scores at week 78) and evaluate the immunogenicity of gosuranemab (using the incidence of anti-gosuranemab antibody responses). Participants were randomized (n = 654); received (n = 650) low-dose (125 mg once every 4 weeks (q4w), n = 58; 375 mg q12w, n = 58), intermediate-dose (600 mg q4w, n = 106) or high-dose (2,000 mg q4w, n = 214) gosuranemab or placebo (q4w, n = 214) intravenously for 78 weeks; and assigned to cerebrospinal fluid (n = 327) and/or tau positron emission tomography (n = 357) biomarker substudies. Gosuranemab had an acceptable safety profile and was generally well tolerated (incidence of serious adverse events: placebo, 12.1%; low dose, 10.3%; intermediate dose, 12.3%; high dose, 11.7%). The incidence of treatment-emergent gosuranemab antibody responses was low at all time points. No significant effects were identified in cognitive and functional tests as no dose resulted in a favorable change from the baseline CDR-SB score at week 78 compared to placebo control (adjusted mean change: placebo, 1.85; low dose, 2.20; intermediate dose, 2.24; high dose, 1.85). At week 76, all doses caused significant (P < 0.0001) reductions in the cerebrospinal fluid levels of unbound N-terminal tau compared to placebo.

Indexed as

Alzheimer DiseaseAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedHumansTomography, X-Ray ComputedAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedgosuranemab

Identifiers

PMID38012285
PMCPMC10724064
OpenAlexW4389058342

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.