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Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00479557
Recruitment Status : Completed
First Posted : May 28, 2007
Results First Posted : January 1, 2016
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 24, 2007
First Posted Date  ICMJE May 28, 2007
Results First Submitted Date  ICMJE May 6, 2014
Results First Posted Date  ICMJE January 1, 2016
Last Update Posted Date January 1, 2016
Study Start Date  ICMJE May 2007
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2007)
Adverse events and other safety assessment, tolerability, and immunogenicity. [ Time Frame: 2 years participation per patient ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2007)
Cognitive and functional measures
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Official Title  ICMJE 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
Brief Summary To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2013)
86
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2007)
56
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00479557
Other Study ID Numbers  ICMJE 3134K1-200
B2571004 ( Other Identifier: Alias Study Number )
2006-002061-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2015

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