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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00955409
Recruitment Status : Completed
First Posted : August 10, 2009
Last Update Posted : January 31, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: ACC-001+ QS21 Drug: ACC-001 Drug: ACC-001 + QS21 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIa, Multicenter, Randomized, Third-Party Unblinded, Long-Term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of ACC-001 With QS-21 Adjuvant In Subjects With Mild To Moderate Alzheimer's Disease
Study Start Date : November 2009
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
ACC-001(3µg) + QS21
Drug: ACC-001+ QS21
Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
ACC-001(10µg) + QS21
Drug: ACC-001
Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
ACC-001(30µg) + QS21
Drug: ACC-001 + QS21
Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18

Outcome Measures

Primary Outcome Measures :
  1. Incidence and severity of treatment emergent adverse events; clinically important changes in safety assessment results including adverse events , vital signs, weight, clinical laboratory tests, ECGs, MRI scans, and physical and neurological examinations. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Change from baseline levels of anti-A-beta IgG, Anti-A-beta IgM and IgG subclass antibody levels at selected time points. [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955409

Pfizer Investigational Site
Bordeaux, France, 33076
Pfizer Investigational Site
Lille, France, 59037
Pfizer Investigational Site
Marseille cedex 5, France, 13385
Pfizer Investigational Site
Paris Cedex 13, France, 75651
Pfizer Investigational Site
Paris, France, 75013
Pfizer Investigational Site
Toulouse cedex 9, France, 31059
Pfizer Investigational Site
Berlin, Germany, 14050
Pfizer Investigational Site
Bonn, Germany, 48129
Pfizer Investigational Site
Bonn, Germany, 53127
Pfizer Investigational Site
Freiburg, Germany, 79106
Pfizer Investigational Site
Goettingen, Germany, 37075
Pfizer Investigational Site
Mannheim, Germany, 68159
Pfizer Investigational Site
Munich, Germany, 81675
Pfizer Investigational Site
Barcelona, Spain, 08003
Pfizer Investigational Site
Barcelona, Spain, 08025
Pfizer Investigational Site
Barcelona, Spain, 08036
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00955409     History of Changes
Other Study ID Numbers: 3134K1-2203
First Posted: August 10, 2009    Key Record Dates
Last Update Posted: January 31, 2014
Last Verified: January 2014

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