Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's Disease (ACCTION)
This study is ongoing, but not recruiting participants.
Sponsor:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01284387
First received: January 20, 2011
Last updated: January 17, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Biological: ACC-001 (vanutide cridificar) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 108 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 3 μg ACC-001 / QS-21 50 μg IM dose 1 |
Biological: ACC-001 (vanutide cridificar)
Comparisons of 2 different doses of ACC-001 or placebo for 24 months
Other Name: vanutide cridificar
|
| Experimental: 10 μg ACC-001 / QS-21 50 μg IM dose 2 |
Biological: ACC-001 (vanutide cridificar)
Comparisons of 2 different doses of ACC-001 or placebo for 24 months
Other Name: vanutide cridificar
|
| No Intervention: Placebo - Phosphate buffered saline (PBS) IM dose |
Eligibility| Ages Eligible for Study: | 50 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284387
Locations
| United States, Arizona | |
| Janssen AI Investigational Site | |
| Sun City, Arizona, United States, 33613 | |
| United States, California | |
| Janssen AI Investigational Site | |
| La Jolla, California, United States, 92093 | |
| Janssen AI Investigational Site | |
| Long Beach, California, United States, 90806 | |
| Janssen AI Investigational Site | |
| Los Angeles, California, United States, 90095 | |
| Janssen AI Investigational Site | |
| Oxnard, California, United States, 93030 | |
| Janssen AI Investigational Site | |
| San Diego, California, United States, 92103 | |
| Janssen AI Investigational Site | |
| San Francisco, California, United States, 94143 | |
| United States, District of Columbia | |
| Janssen AI Investigational Site | |
| Washington, District of Columbia, United States, 20057 | |
| United States, Florida | |
| Janssen AI Investigational Site | |
| Miami, Florida, United States, 33137 | |
| Janssen AI Investigational Site | |
| Miami, Florida, United States, 33410 | |
| Janssen AI Investigational Site | |
| Ocala, Florida, United States, 34471 | |
| Janssen AI Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| Janssen AI Investigational Site | |
| Sunrise, Florida, United States, 33351 | |
| Janssen AI Investigational Site | |
| Tampa, Florida, United States, 33609 | |
| Janssen AI Investigational Site | |
| Tampa, Florida, United States, 33617 | |
| Janssen AI Investigational Site | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Maine | |
| Janssen AI Investigational Site | |
| Scarborough, Maine, United States, 04074 | |
| United States, Massachusetts | |
| Janssen AI Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Missouri | |
| Janssen AI Investigational Site | |
| Kansas City, Missouri, United States, 64111 | |
| United States, Nevada | |
| Janssen AI Investigational Site | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| Janssen AI Investigational Site | |
| Princeton, New Jersey, United States, 08540 | |
| United States, New York | |
| Janssen AI Investigational Site | |
| Albany, New York, United States, 12205 | |
| Janssen AI Investigational Site | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Janssen AI Investigational Site | |
| Centerville, Ohio, United States, 45459 | |
| United States, Oklahoma | |
| Janssen AI Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
More Information
No publications provided
| Responsible Party: | JANSSEN Alzheimer Immunotherapy Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT01284387 History of Changes |
| Other Study ID Numbers: | ACC-001-ALZ-2001 |
| Study First Received: | January 20, 2011 |
| Last Updated: | January 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:
|
Mild to moderate Alzheimer's disease immunization amyloid imaging injection vaccine |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013