Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's Disease (ACCTION)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01284387
First received: January 20, 2011
Last updated: February 26, 2014
Last verified: February 2014

January 20, 2011
February 26, 2014
January 2011
January 2014   (final data collection date for primary outcome measure)
To evaluate the effect of ACC-001 in combination with an adjuvant immunostimulatory agent (QS-21), administered intramuscularly compared to placebo on cerebral amyloid burden in subjects with mild to moderate Alzheimer's disease. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01284387 on ClinicalTrials.gov Archive Site
  • To evaluate the safety and tolerability of 2 dosage levels of ACC-001 plus QS-21 vs. placebo in subjects with mild to moderate AD. [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]

    As assessed by:

    • The incidence and severity of treatment-emergent adverse events (TEAEs); and
    • Clinically important changes in safety assessment results (vital signs, weight, clinical laboratory tests, electrocardiograms [ECGs], brain magnetic resonance imaging [MRIs], and physical and neurological examinations).
  • Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in disease biomarkers. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in measurements of immunogenicity. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in cognitive and functional scales. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in health outcome measures. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's Disease
A Phase 2, 24-Month, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Amyloid-Imaging Positron Emission Tomography (PET) and Safety Study of ACC-001 and QS-21 Adjuvant in Subjects With Mild to Moderate Alzheimer's Disease

A Phase II clinical research study to evaluate the efficacy and safety of two different dose levels of an injectable investigational treatment (ACC-001) in subjects with Mild-to-Moderate Alzheimer's disease. ACC-001 (vanutide cridificar) is a beta amyloid fragment attached to a carrier protein. It is intended to help induce an antibody response against beta amyloid and is administered as an intramuscular injection.

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 (vanutide cridificar)
Comparisons of 2 different doses of ACC-001 or placebo for 24 months
Other Name: vanutide cridificar
  • Experimental: 3 μg ACC-001 / QS-21 50 μg IM dose 1
    3 μg ACC-001 / QS-21 50 μg IM
    Intervention: Biological: ACC-001 (vanutide cridificar)
  • Experimental: 10 μg ACC-001 / QS-21 50 μg IM dose 2
    10 μg ACC-001 / QS-21 50 μg IM
    Intervention: Biological: ACC-001 (vanutide cridificar)
  • No Intervention: Placebo - Phosphate buffered saline (PBS) IM dose
    Placebo - Phosphate buffered saline (PBS) IM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
February 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of probable AD
  • Age from 50 to 89
  • Mini-Mental Status Exam score of 18-26 inclusive
  • Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
  • Stable doses of medications (cholinesterase inhibitors and memantine allowed)
  • Caregiver able to attend all clinic visits with patient
  • Amyloid burden on screening PET scan consistent with diagnosis of AD

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Significant systemic illness
  • History of stroke, seizure or autoimmune disease
  • History of myocardial infarction within the last 2 years
  • Smoking greater than 20 cigarettes per day
  • Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications (anticonvulsants used for non-seizure reasons are allowed)
  • Prior treatment experimental immunotherapeutics or vaccines for AD
  • Women of childbearing potential
  • Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body
Both
50 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01284387
ACC-001-ALZ-2001
Yes
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
Not Provided
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
February 2014

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