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Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early 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:
NCT01227564
First received: October 22, 2010
Last updated: June 13, 2014
Last verified: June 2014

October 22, 2010
June 13, 2014
January 2011
February 2014   (final data collection date for primary outcome measure)
  • Explore the capacity of 2 dosage levels of ACC-001 plus QS-21 to remove brain fibrillar Aβ in subjects with early AD. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability of 2 dosage levels of ACC-001 plus QS-21 in subjects with early AD. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To explore the capacity of 2 dosage levels of ACC-001 plus QS-21 to remove brain fibrillar Aβ in subjects with early AD. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of 2 dosage levels of ACC-001 plus QS-21 in subjects with early AD. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01227564 on ClinicalTrials.gov Archive Site
  • Change from baseline in disease biomarkers. [ Time Frame: study duration ] [ Designated as safety issue: No ]
  • Change from baseline in measurements of immunogenicity. [ Time Frame: study duration ] [ Designated as safety issue: No ]
  • Change from baseline in cognitive and functional scales. [ Time Frame: study duration ] [ Designated as safety issue: No ]
  • Change from baseline in health outcome measures. [ Time Frame: study duration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease
A Phase 2, Multicenter, 24-Month, Randomized, Third-Party Unblinded, Placebo-Controlled, Parallel-Group Amyloid Imaging Positron Emission Tomography (Pet) And Safety Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Early Alzheimer's Disease

This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as measured by positron emission tomography (PET) scans.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Biological: ACC-001 3 μg/ QS-21 50 μg
    ACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18
    Other Name: Vanutide Cridificar
  • Biological: ACC-001 10 μg/ QS-21 50 μg
    ACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18
    Other Name: Vanutide Cridificar
  • Other: Placebo- Phosphate buffered saline (PBS)
    Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18
  • Experimental: ACC-001 3 μg/ QS-21 50 μg
    Intervention: Biological: ACC-001 3 μg/ QS-21 50 μg
  • Experimental: ACC-001 10 μg/ QS-21 50 μg
    Intervention: Biological: ACC-001 10 μg/ QS-21 50 μg
  • Placebo Comparator: Placebo- Phosphate buffered saline (PBS)
    Intervention: Other: Placebo- Phosphate buffered saline (PBS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Concern about a change in cognition expressed by the subject or by an informant that knows the subject well
  • Mini-Mental State Examination (MMSE) score ≥ 25
  • Global Clinical Dementia Rating = 0.5.
  • General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's dementia cannot not be made by the site physician at the time of screening.
  • Amyloid burden detected on screening brain PET scan.
  • Other inclusion criteria apply.

Exclusion Criteria:

  • Significant neurological disease other than early Alzheimer's disease
  • Major psychiatric disorder or symptom
  • Contraindication to undergo brain MRI
  • Unstable medical conditions
  • Other exclusion criteria apply
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01227564
B2571010, B2571010
Yes
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

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