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First-in-human, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study of Aducanumab (BIIB037) in Mild-To-Moderate Alzheimer's Disease

First-in-human, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study of Aducanumab (BIIB037) in Mild-To-Moderate Alzheimer's Disease

James Ferrero, Leslie Williams, Heather Stella, Kate Leitermann, Alvydas Mikulskis, John O'Gorman, Jeff Sevigny

Alzheimers Dement (N Y). 2016 Jun 20;2(3):169-176.

PMID: 29067304

Abstract:

Introduction:
Aducanumab (BIIB037), a human monoclonal antibody selective for aggregated forms of amyloid beta, is being investigated as a disease-modifying treatment for Alzheimer's disease (AD).
Methods:
This randomized, double-blind, placebo-controlled single ascending-dose study investigated the safety, tolerability, and pharmacokinetics (PK) of aducanumab in patients with mild-to-moderate AD. Eligible patients were sequentially randomized 6:2 to aducanumab (0.3, 1, 3, 10, 20, 30, and 60 mg/kg) or placebo.
Results:
The primary outcome was safety and tolerability. Doses ≤30 mg/kg were generally well tolerated with no severe or serious adverse events (SAEs). All three patients who received 60 mg/kg aducanumab developed SAEs of symptomatic amyloid-related imaging abnormalities, which completely resolved by weeks 8-15. Aducanumab Cmax, AUC0-last, and AUCinf increased in a dose-proportional manner.
Discussion:
In this single-dose study, aducanumab demonstrated an acceptable safety and tolerability profile and linear PK at doses ≤30 mg/kg (clinicaltrials.govNCT01397539).

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
IAR4248090	Amyloid β 10-20 human			Price

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