Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer Disease
• Interventions: Biological: ACC-001(30µg) + QS21; Biological: ACC-001(3µg) + QS21; Biological: ACC-001(10µg) + QS21

• Registration Number: NCT00955409
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, in subjects with mild to moderate Alzheimer's disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-07
• Study First Posted: 2009-08-10
• Study Start: 2009-11-05
• Primary Completion: 2013-12-17
• Study Completion: 2013-12-17
• Results First Submitted: 2014-12-17
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-01
• Last Update Submitted: 2021-03-01
• Results First Posted: 2021-03-25
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Subjects randomized under previous 3134K1-200 study (NCT00479557) and met all inclusion/and none of the exclusion criteria
• Screening brain MRI scan is consistent with the diagnosis of AD ' Mini-Mental State Examination (MMSE) score ≥10

Exclusion Criteria

• Significant Neurological Disease other than Alzheimer's disease
• Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)
• Clinically significant systemic illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACC-001(30µg) + QS21	ACC-001(30µg) + QS21	ACC-001(30µg) + QS21
ACC-001(3µg) + QS21	ACC-001(3µg) + QS21	ACC-001(3µg) + QS21
ACC-001(10µg) + QS21	ACC-001(10µg) + QS21	ACC-001(10µg) + QS21

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	24 months	An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Trial Locations

Locations (17)

Klinikum der Albert-Ludwigs-Universitaet Freiburg; 🇩🇪 Freiburg, Germany

Groupe Hospitalier Pitie-Salpetriere; 🇫🇷 Paris, France

Universitatsklinikum und Poliklinik der Uni Bonn; 🇩🇪 Bonn, Germany

Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany

CMRR Bordeaux CHU Pellegrin; 🇫🇷 Bordeaux Cedex, France

CHU La Timone; 🇫🇷 Marseille cedex 5, France

Klinik fuer Psychiatrie und Psychotherapie; 🇩🇪 Goettingen, Germany

Hôpital La Grave; 🇫🇷 Toulouse cedex 9, France

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hopital Roger Salengro; 🇫🇷 Lille, France

Hôpital Roger Salengro; 🇫🇷 Lille, France

Hôpital Pitié-Salpétrière; 🇫🇷 Paris Cedex 13, France

Technische Universität München; 🇩🇪 Munich, Germany

Hospital Clinico y Provincial; 🇪🇸 Barcelona, Spain

Groupe Hospitalier Broca-La Rochefoucauld; 🇫🇷 Paris, France

Zentralinstitut fuer Seelische Gesundheit Mannheim; 🇩🇪 Mannheim, Germany