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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 (JAI) Research and Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00479557
First received: May 24, 2007
Last updated: November 30, 2015
Last verified: November 2015
History of Changes
May 24, 2007
November 30, 2015
May 2007
January 2013   (Final data collection date for primary outcome measure)
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) [ Time Frame: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose. ]
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.
Adverse events and other safety assessment, tolerability, and immunogenicity. [ Time Frame: 2 years participation per patient ]
Complete list of historical versions of study NCT00479557 on ClinicalTrials.gov Archive Site
  • Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ]
    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.
  • GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ]
    The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.
  • Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable) [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ]
    IgG subtypes were not assessed
Cognitive and functional measures
Not Provided
Not Provided
 
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, 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 assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer Disease
  • Biological: ACC-001 + QS-21
    Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
  • Biological: ACC-001
    Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12
  • Biological: QS-21
    QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
  • Drug: Placebo: Phosphate buffered saline
    Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12
  • Active Comparator: 1
    arm 1: ACC-001 (Vanutide Cridificar)+ QS-21
    Intervention: Biological: ACC-001 + QS-21
  • Active Comparator: 2
    arm 2: ACC-001
    Intervention: Biological: ACC-001
  • Placebo Comparator: 3
    arm 3: QS-21
    Intervention: Biological: QS-21
  • Placebo Comparator: 4
    Drug: Phosphate Buffered Saline (PBS)
    Intervention: Drug: Placebo: Phosphate buffered saline
Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
January 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)
  • Brain MRI consistent with Alzheimer Disease
  • Concurent use of Chloniesterase inhibitor or memantine allowed if stable
  • Other inclusion criteria apply

Exclusion Criteria:

  • Significant Neurological Disease other than Alzheimer's disease
  • Major psychiatric disorder
  • Contraindication to undergo brain MRI
  • Clinically significant systemic illness
  • Other exclusion criteria apply
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Spain
 
 
NCT00479557
3134K1-200
B2571004 ( Other Identifier: Alias Study Number )
2006-002061-39 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2015

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