In:
Alzheimer's & Dementia, Wiley, Vol. 16, No. S9 ( 2020-12)
Abstract:
Gosuranemab is a humanized monoclonal antibody binding tau at the N‐terminal domain. The TANGO study is a randomized, placebo‐controlled, global Phase 2 Study evaluating safety and clinical efficacy of gosuranemab in patients diagnosed with mild cognitive impairment (MCI) due to AD or mild AD dementia. We describe baseline characteristics from the TANGO study, the first evaluation of gosuranemab in AD. Method Randomized, double‐blind, placebo‐controlled, parallel‐group Phase 2 study (TANGO) enrolled globally over 600 individuals aged 50‐80 years, diagnosed with MCI due to AD or mild AD, Clinical Dementia Rating (CDR) global score 0.5‐1, CDR Memory Box score of ≥0.5, Mini‐Mental State Examination (MMSE) score 22‐30, objective evidence of cognitive impairment at Screening and elevated brain amyloid as assessed by PET or cerebrospinal fluid (CSF) levels. Participants were randomized 1:1:2:2 to monthly intravenous low, medium, high dose of gosuranemab or placebo during the 76‐week treatment period. After completion of the placebo‐controlled period, patients may enter a long‐term extension during which all patients receive gosuranemab. The primary endpoints included incidences of adverse events, serious adverse events, abnormalities in safety assessments. The secondary endpoints included change from baseline in CDR‐Sum of Boxes score and incidence of anti‐gosuranemab antibodies in serum. Key exploratory endpoints included change from baseline in MMSE, AD Cooperative Study‐Activities of Daily Living, Functional Activities Questionnaire, AD Assessment Scale‐Cognitive Subscale, tau levels in CSF and/or in brain measured by 18 F‐MK6240 PET and pharmacokinetic parameters. Result TANGO is now fully enrolled and ongoing; over 600 patients were randomized and have received ≥1 dose of study medication. Approximately half of the patients were enrolled in either the CSF or tau PET sub‐studies. Approximately half of the patients are women (50.5%). The percentage of patients diagnosed with Mild AD at baseline is 53%. MMSE mean (standard deviation [SD]) score at baseline was 25 (2.3). Conclusion TANGO will assess the safety profile, tolerability and clinical efficacy of gosuranemab in individuals who, per baseline characteristics, are representative of patients with early AD. Study Support: funded by Biogen.
Type of Medium:
Online Resource
ISSN:
1552-5260
,
1552-5279
Language:
English
Publisher:
Wiley
Publication Date:
2020
detail.hit.zdb_id:
2201940-6
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