Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
- Conditions
- Alzheimer Disease
- Interventions
- Biological: QS-21Biological: ACC-001 + QS-21Biological: ACC-001
- Registration Number
- NCT00479557
- Lead Sponsor
- Pfizer
- Brief Summary
To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)
- Brain MRI consistent with Alzheimer Disease
- Concurent use of Chloniesterase inhibitor or memantine allowed if stable
- Other inclusion criteria apply
- Significant Neurological Disease other than Alzheimer's disease
- Major psychiatric disorder
- Contraindication to undergo brain MRI
- Clinically significant systemic illness
- Other exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 QS-21 arm 3: QS-21 1 ACC-001 + QS-21 arm 1: ACC-001 (Vanutide Cridificar)+ QS-21 2 ACC-001 arm 2: ACC-001
- Primary Outcome Measures
Name Time Method Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose. 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.
- Secondary Outcome Measures
Name Time Method Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.
GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.
Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable) Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 IgG subtypes were not assessed
Trial Locations
- Locations (21)
Unversitätsklinikum Freiburg
🇩🇪Freiburg, Baden- Württemberg, Germany
Hôpital LA GRAVE
🇫🇷TOULOUSE Cedex 9, France
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Klinik fuer Psychiatrie und Psychotherapie
🇩🇪Goettingen, Germany
Clinique PASTEUR
🇫🇷Toulouse, France
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Clinico y Provincial
🇪🇸Barcelona, Spain
Zentralinstitut fuer Seelische Gesundheit
🇩🇪Mannheim, Germany
Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Technische Universitaet Muenchen, Klinikum rechts der Isar
🇩🇪München, Germany
Hôpital Sainte-Marguerite
🇫🇷MARSEILLE cedex 5, France
CHU Hôpital Gui de Chaulliac
🇫🇷Montpellier, France
Groupe Hospitalier Pitie-Salpetriere
🇫🇷Paris, Cedex 13 (MRI), France
CHRU de Lille
🇫🇷Lille, France
Hopital Pellegrin-Centre Mémoire de Recherche et de Ressources
🇫🇷Bordeaux, France
Hôpital Pitié-Salpétrière
🇫🇷Paris Cedex 13, Paris, France
Groupe Hospitalier Broca-La Rochefoucauld
🇫🇷Paris, France
Clinique de L'Union
🇫🇷St JEAN, France
Chru Purpan
🇫🇷Toulouse, France
Hospital Universitario Clinico San Carlos
🇪🇸Madrid, Spain
Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin
🇩🇪Berlin, Germany