Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's Disease (ACCTION)
This study has been completed.
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: December 11, 2014
Last verified: December 2014
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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:
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 ]
| Enrollment: | 126 |
| Study Start Date: | January 2011 |
| Study Completion Date: | February 2014 |
| 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
3 μg ACC-001 / QS-21 50 μg IM
|
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
10 μg ACC-001 / QS-21 50 μg IM
|
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
Placebo - Phosphate buffered saline (PBS) IM
|
Eligibility| Ages Eligible for Study: | 50 Years to 89 Years (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284387
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
| 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: | December 11, 2014 |
| 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 |
Neurocognitive Disorders Mental Disorders QS 21 Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 29, 2016