Study Evaluating 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:
NCT00498602
First received: July 9, 2007
Last updated: March 12, 2013
Last verified: March 2013

July 9, 2007
March 12, 2013
November 2007
February 2013   (final data collection date for primary outcome measure)
  • The incidence and severity of treatment-emergent adverse events (TEAEs). [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Clinically important changes in safety assessment results. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Adverse events, other safety assessments, tolerability, and immunogenicity.
Complete list of historical versions of study NCT00498602 on ClinicalTrials.gov Archive Site
  • To assess the immunogenicity of each dose level of ACC-001 with or without QS-21 in subjects with mild to moderate AD. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Change from baseline blood levels of anti A-beta immunoglobulin G (IgG) and immunoglobulin M (IgM) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Cognitive and functional measures.
Not Provided
Not Provided
 
Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
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.

To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, 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
  • Biological: ACC-001 + QS-21
    IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52
  • Biological: QS-21
    IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52
  • Other: Diluent: Phosphate Buffered Saline
    IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52
  • Biological: ACC-001
    IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52
  • Experimental: 1
    ACC-001
    Intervention: Biological: ACC-001 + QS-21
  • 2
    QS-21
    Intervention: Biological: QS-21
  • 3
    Diluent: Phosphate Buffered Saline
    Intervention: Other: Diluent: Phosphate Buffered Saline
  • Experimental: 4
    ACC-001
    Intervention: Biological: ACC-001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
245
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of mild to moderate Alzheimer`s disease
  • Age 50-85
  • Mini Mental State Examination (MMSE) 16-26 Other criteria apply

Exclusion Criteria:

  • Significant Neurological Disease
  • Major psychiatric disorder
  • Clinically significant systemic illness Other exclusion criteria apply.
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00498602
3134K1-2201, B2571005
Yes
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2013

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