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: February 15, 2013
Last verified: February 2013

May 24, 2007
February 15, 2013
May 2007
January 2013   (final data collection date for primary outcome measure)
Assess the safety and tolerability of multiple doses of ACC-001 in subjects with mild to moderate AD. [ Time Frame: 2 years participation per patient ] [ Designated as safety issue: Yes ]
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
Assess the immunogenicity of each dose level of ACC-001 with or without QS-21 in subjects with mild to moderate AD. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
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
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
    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
Not Provided

*   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
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Spain,   Germany
 
NCT00479557
3134K1-200, B2571004
Yes
Pfizer
Pfizer
Janssen Alzheimer Immunotherapy (JAI) Research and 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