Long Term Extension 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 Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00955409
First received: August 4, 2009
Last updated: January 29, 2014
Last verified: January 2014

August 4, 2009
January 29, 2014
November 2009
December 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00955409 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer Disease
  • Drug: ACC-001+ QS21
    Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
  • Drug: ACC-001
    Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
  • Drug: ACC-001 + QS21
    Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
  • 1
    ACC-001(3µg) + QS21
    Intervention: Drug: ACC-001+ QS21
  • 2
    ACC-001(10µg) + QS21
    Intervention: Drug: ACC-001
  • 3
    ACC-001(30µg) + QS21
    Intervention: Drug: ACC-001 + QS21
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Spain
 
NCT00955409
3134K1-2203, B2571007
Yes
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP