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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: February 15, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Assess the safety and tolerability of multiple doses of ACC-001 in subjects with mild to moderate AD. [ Time Frame: 2 years participation per patient ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the immunogenicity of each dose level of ACC-001 with or without QS-21 in subjects with mild to moderate AD. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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

Locations
France
Pfizer Investigational Site
Paris Cedex 13, Paris, France, 75651
Pfizer Investigational Site
Bordeaux, France, 33076
Pfizer Investigational Site
Lille, France, 59037
Pfizer Investigational Site
MARSEILLE cedex 5, France, 13385
Pfizer Investigational Site
Montpellier, France, 34295
Pfizer Investigational Site
Paris, France, 75013
Pfizer Investigational Site
Toulouse, France, 31300
Pfizer Investigational Site
TOULOUSE cedex 9, France, 31059
Germany
Pfizer Investigational Site
Berlin, Germany, 14050
Pfizer Investigational Site
Frankenthal, Germany, 67227
Pfizer Investigational Site
Freiburg, Germany, 79106
Pfizer Investigational Site
Goettingen, Germany, 37075
Pfizer Investigational Site
Mannheim, Germany, 68159
Pfizer Investigational Site
Muenchen, Germany, 81675
Pfizer Investigational Site
Muenster, Germany, 48149
Pfizer Investigational Site
Muenster, Germany, 48165
Spain
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Barcelona, Spain, 08025
Pfizer Investigational Site
Barcelona, Spain, 08003
Pfizer Investigational Site
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00479557     History of Changes
Other Study ID Numbers: 3134K1-200, B2571004
Study First Received: May 24, 2007
Last Updated: February 15, 2013
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
 Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
QS 21
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013