Name:	ACC-001
Therapeutic Applications:	Alzheimer disease
Therapy Types:	Immuno-conjugate
Development Status:	investigational in U.S.
FDA Phase:	Phase II/IIa/IIb
Primary Medical Role:	Elan is exploring a novel Aβ immuno-conjugate that draws on conjugate technology Wyeth has used in some pediatric vaccines. An Aβ fragment is attached to a carrier protein intended to help induce an antibody response against Aβ. In fall 2005, Elan and Wyeth began dosing patients with the active Aβ immunotherapeutic conjugate in a Phase I trial designed to measure the safety of a single dose of ACC-001 in patients with mild to moderate AD. The trial will enroll approximately 70 patients at five sites in the U.S. The active-to-placebo ratio will be 3:1:1 (ACC-001+/- adjuvant and placebo). Each patient will receive a single dose of drug or placebo and then be followed for 12 months for safety.
Role in Alzheimer's Disease:	Elan research indicates that antibodies specific for Aβ peptide can cross the blood-brain barrier and act directly in the central nervous system to induce plaque clearance. These findings suggest that this novel method may clear plaques in human patients.
Companies:	Elan Corporation, Wyeth
Notes:	Phase II started recruiting participants in October 2008. ClinicalTrials.gov NCT00479557 (Safety, Tolerability and Immunogenicity in Mild to Moderate Alzheimer Disease) and NCT00498602 (Efficacy in Mild to Moderate Alzheimer Disease). This record updated Dec 10, 2008.