A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease

This study has been terminated.
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00960531
First received: August 13, 2009
Last updated: March 2, 2016
Last verified: March 2016

August 13, 2009
March 2, 2016
July 2009
December 2013   (final data collection date for primary outcome measure)
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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 ]
Complete list of historical versions of study NCT00960531 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
  • GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 [ Time Frame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 ] [ Designated as safety issue: No ]
    IgM was not statistically analyzed.
  • Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable) [ Time Frame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 ] [ Designated as safety issue: No ]
    IgG subtypes were not assessed
  • Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 [ Time Frame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 ] [ Designated as safety issue: Yes ]
    The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.
Not Provided
 
A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease
A Phase 2a, Multicenter, Randomized, Third-party Un-blinded, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer Disease
The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, plus QS-21 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+ QS21 (3mcg)
    ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
  • Biological: ACC-001 (10 mcg) + QS-21
    ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
  • Biological: ACC-001+QS-21 (30mcg)
    ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
  • Experimental: ACC-001 (3mcg) + QS-21
    ACC-001 (3mcg) + QS-21
    Intervention: Biological: ACC-001+ QS21 (3mcg)
  • Experimental: ACC-001 (10mcg) + QS-21
    ACC-001 (10mcg) + QS-21
    Intervention: Biological: ACC-001 (10 mcg) + QS-21
  • Experimental: ACC-001 (30mcg) + QS-21
    ACC-001 (30mcg) + QS-21
    Intervention: Biological: ACC-001+QS-21 (30mcg)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
160
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects randomized under previous 3134K1-2201 study (NCT00498602) 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 greater than or equal to 10.

Other criteria apply.

Exclusion Criteria:

Significant Neurological Disease other than Alzheimer's disease.

Current clinically significant systemic illness.

Other exclusion criteria apply.

Both
50 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00960531
3134K1-2205, B2571008
Yes
Not Provided
Not Provided
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2016

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