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Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese 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:
NCT00959192
First received: August 13, 2009
Last updated: February 6, 2013
Last verified: February 2013
History of Changes

August 13, 2009
February 6, 2013
August 2009
January 2013   (final data collection date for primary outcome measure)
  • Incidence and severity of Treatment Emergent Adverse Events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Clinically important changes in safety assessment results, including AEs, vital signs, weight, laboratory tests, ECGs, MRI, physical and neurological examinations [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Primary Outcome Measures: Incidence and severity of treatment-emergent adverse events (TEAEs); Clinically important changes in safety assessment results (including AEs, vital signs, clinical laboratory tests, ECGs, MRI, physical and neurological exam) [ Time Frame: 2 years participation per patient ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00959192 on ClinicalTrials.gov Archive Site
  • Anti-a-beta IgG and IgM titer, and IgG subtype titer if applicable, at specified visits [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Changes of ADAS-Cog, DAD, NTB and MMSE scores from baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures: Change from baseline levels of anti A-beta immunoglobulin G (IgG). The change from baseline scores for the ADAS-Cog, DAD, NTB, MMSE. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
A Phase IIA, Multicenter, Randomized, Third-Party Unblinded, Adjuvant-Controlled, Multiple Ascending Dose, Safety, Tolerability, And Immunogenicity Trial Of ACC-001 With QS-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease

The purpose of this study is to assess the safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, in subjects with mild to moderate Alzheimer's disease in Japan.
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's Disease
  • Biological: ACC-001
    IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
  • Other: QS-21
    IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12
  • Other: QS-21
    IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
  • Experimental: ACC-001 + QS-21
    Active vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
    Interventions:
    • Biological: ACC-001
    • Other: QS-21
  • Placebo Comparator: QS-21
    Adjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
    Intervention: Other: QS-21
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of mild to moderate Alzheimer's Disease
  • Mini-Mental State Examination (MMSE) 16-26

Exclusion Criteria:

  • Significant Neurological Disease other than Alzheimer's disease
  • Major psychiatric disorder
  • Clinically significant systemic illness
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00959192
3134K1-2206, B2571009
Yes
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

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