BIIB092 in Primary Tauopathies: CBS, nfvPPA, sMAPT, and TES — TauBasket  

Nonfluent Aphasia, Progressive Clinical Trial

Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel Cohort Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Intravenously Infused BIIB092 in Patients With Four Different Primary Tauopathy Syndromes

Status Terminated

Clinical Trial Summary

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel Cohort Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Intravenously Infused BIIB092 in Patients with Four Different Primary Tauopathy Syndromes

Clinical Trial Description

This is a phase 1b randomized, double-blind, safety, and tolerability clinical trial of an investigational drug, called BIIB092 in patients with four different primary tauopathy syndromes: amyloid PET (-) corticobasal syndrome (CBS), nonfluent variant primary progressive aphasia (nfvPPA), symptomatic patients with autosomal dominant genetic forms of frontotemporal lobar degeneration (FTD) due to the presence of a mutation in the microtubule-associated protein tau gene (sMAPT), and traumatic encephalopathy syndromes (TES). Primary tauopathies are neurodegenerative brain disorders in which tau is the only protein that accumulates at autopsy. While Alzheimer's disease (AD) is the most common tauopathy, it is considered a secondary tauopathy, because tau protein accumulates along with another pathogenic protein, amyloid beta. Primary tauopathies are rare diseases for which there is no treatment or cure. The purpose of the this study is to characterize the safety and tolerability profile of intravenous BIIB092 in four primary tauopathies.

A basket design will be used for a parallel evaluation of BIIB092 in four heterogenous clinicopathological syndromes that share a common molecular target (tau). ;

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Broca
• Aphasia, Primary Progressive
• Brain Diseases
• Brain Injuries, Traumatic
• Corticobasal Degeneration Syndrome
• Frontotemporal Dementia
• Frontotemporal Lobar Degeneration
• Frontotemporal Lobar Degeneration With Tau Inclusions
• MAPT Mutation Carriers, Symptomatic
• Nonfluent Aphasia, Progressive
• Pick Disease of the Brain
• Primary Progressive Nonfluent Aphasia
• Primary Tauopathies
• Syndrome
• Tauopathies
• Traumatic Encephalopathy Syndrome

• NCT number: NCT03658135
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Terminated
• Phase: Phase 1
• Start date: September 12, 2018
• Completion date: December 13, 2019