Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00479557
First received: May 24, 2007
Last updated: November 30, 2015
Last verified: November 2015
  Purpose
To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.

Condition Intervention Phase
Alzheimer Disease
Biological: ACC-001 + QS-21
Biological: ACC-001
Biological: QS-21
Drug: Placebo: Phosphate buffered saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) [ Time Frame: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose. ] [ Designated as safety issue: Yes ]
    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:
  • 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 [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ] [ Designated as safety issue: No ]
    IgG subtypes were not assessed


Enrollment: 86
Study Start Date: May 2007
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
arm 1: ACC-001 (Vanutide Cridificar)+ QS-21
Biological: ACC-001 + QS-21
Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
Active Comparator: 2
arm 2: ACC-001
Biological: ACC-001
Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12
Placebo Comparator: 3
arm 3: QS-21
Biological: QS-21
QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
Placebo Comparator: 4
Drug: Phosphate Buffered Saline (PBS)
Drug: Placebo: Phosphate buffered saline
Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Significant Neurological Disease other than Alzheimer's disease
  • Major psychiatric disorder
  • Contraindication to undergo brain MRI
  • Clinically significant systemic illness
  • Other exclusion criteria apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479557

Locations
France
Groupe Hospitalier Pitie-Salpetriere
Paris, Cedex 13 (MRI), France, 75651
Hôpital Pitié-Salpétrière
Paris Cedex 13, Paris, France, 75651
Hopital Pellegrin-Centre Mémoire de Recherche et de Ressources
Bordeaux, France, 33076
CHRU de Lille
Lille (MRI), France, 59037
CHRU de Lille
Lille, France, 59037
Hôpital Sainte-Marguerite
MARSEILLE cedex 5, France, 13385
CHU Hôpital Gui de Chaulliac
Montpellier, France, 34295
Groupe Hospitalier Broca-La Rochefoucauld
Paris, France, 75013
Clinique de L'Union
St JEAN, France, 31240
Hôpital LA GRAVE
TOULOUSE Cedex 9, France, 31059
Chru Purpan
Toulouse, France, 31300
Clinique PASTEUR
Toulouse, France, 31300
Germany
Unversitätsklinikum Freiburg
Freiburg, Baden- Württemberg, Germany, 79106
Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin
Berlin, Germany, 14050
Zentralinstitut fuer Seelische Gesundheit
Frankenthal, Germany, 67227
Klinik fuer Psychiatrie und Psychotherapie
Goettingen, Germany, 37075
Zentralinstitut fuer Seelische Gesundheit
Mannheim, Germany, 68159
Universitaetsklinikum Muenster
Muenster, Germany, 48149
Universitaetsklinikum Muenster
Muenster, Germany, 48165
Technische Universitaet Muenchen, Klinikum rechts der Isar
München, Germany, 81675
Spain
Hospital del Mar
Barcelona, Spain, 08003
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Clinico y Provincial
Barcelona, Spain, 08036
Hospital Universitario Clinico San Carlos
Madrid, Spain, 28040
Sponsors and Collaborators
Pfizer
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00479557     History of Changes
Other Study ID Numbers: 3134K1-200  B2571004  2006-002061-39 
Study First Received: May 24, 2007
Results First Received: May 6, 2014
Last Updated: November 30, 2015
Health Authority: European Union: European Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Spain: Ministry of Health

Keywords provided by Pfizer:
Alzheimer's Disease
active immunization

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
QS 21
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016