Trial intelligence / Profile preview

ACC-001 + QS-21 extension in Alzheimer's

NCT00960531Phase 2

Key facts

Status
Terminated
Start
Jul 2009
Primary completion
Dec 2013
Countries
1
Sponsor
Pfizer
Modality
Antibody Conjugates, Peptide-based Cancer Vaccines
Conditions
Alzheimer's disease (AD)
01

Overview

Phase 2, randomised, double-blind trial of vanutide cridificar in Alzheimer's disease (AD) (3 arms), sponsored by Pfizer. Primary endpoint: Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) at 24 months. Started Jul 2009; status: terminated.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • ACC-001 (3mcg) + QS-21

    ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

  • ACC-001 (10mcg) + QS-21

    ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

  • ACC-001 (30mcg) + QS-21

    ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

03

Who it enrols

Subjects randomized under previous 3134K1-2201 study (NCT00498602) with mild to moderate Alzheimer's disease.

04

Endpoints

Primary

  • Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)

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