A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00960531
First received: August 13, 2009
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate Alzheimer's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: ACC-001+ QS21 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase IIa, Multicenter, Randomized, Third-Party Unblinded, Long-Term Extension Study to Determine Safety, Tolerability, and Immunogenicity of ACC-001 With 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 Pfizer:
Primary Outcome Measures:
- Incidence and severity of treatment emergent adverse events. Clinically important changes in safety assessment results. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 160 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
ACC-001 + QS-21
|
Drug: ACC-001+ QS21
IM injection, ACC-001(3mcg, or 10mcg, or 30mcg) + QS-21 50 mcg at Day 1 and weeks 26, 52, and 78
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Subjects randomized under previous 3134K1-2201 study (NCT00498602) and met all inclusion/and none of the exclusion criteria.
Screening brain MRI scan is consistent with the diagnosis of AD.
Mini-Mental State Examination (MMSE) score greater than or equal to 10.
Other criteria apply.
Exclusion Criteria:
Significant Neurological Disease other than Alzheimer's disease.
Current clinically significant systemic illness.
Other exclusion criteria apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00960531
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, Arizona | |
| Pfizer Investigational Site | Recruiting |
| Phoenix, Arizona, United States, 85006 | |
| Pfizer Investigational Site | Recruiting |
| Sun City, Arizona, United States, 85351 | |
| United States, California | |
| Pfizer Investigational Site | Recruiting |
| San Francisco, California, United States, 94117 | |
| Pfizer Investigational Site | Recruiting |
| San Francisco, California, United States, 94158 | |
| Pfizer Investigational Site | Recruiting |
| San Francisco, California, United States, 94143 | |
| United States, Connecticut | |
| Pfizer Investigational Site | Active, not recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Pfizer Investigational Site | Active, not recruiting |
| New Haven, Connecticut, United States, 06511 | |
| United States, District of Columbia | |
| Pfizer Investigational Site | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Pfizer Investigational Site | Recruiting |
| Washington, District of Columbia, United States, 20057 | |
| United States, Florida | |
| Pfizer Investigational Site | Completed |
| Hallandale Beach, Florida, United States, 33009 | |
| Pfizer Investigational Site | Recruiting |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| United States, Missouri | |
| Pfizer Investigational Site | Active, not recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Pfizer Investigational Site | Active, not recruiting |
| St. Louis, Missouri, United States, 63108 | |
| United States, New Jersey | |
| Pfizer Investigational Site | Recruiting |
| Eatontown, New Jersey, United States, 07724 | |
| United States, New York | |
| Pfizer Investigational Site | Recruiting |
| New York, New York, United States, 10032 | |
| United States, Rhode Island | |
| Pfizer Investigational Site | Recruiting |
| Providence, Rhode Island, United States, 02906 | |
| United States, Vermont | |
| Pfizer Investigational Site | Recruiting |
| Bennington, Vermont, United States, 05201 | |
Sponsors and Collaborators
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00960531 History of Changes |
| Other Study ID Numbers: | 3134K1-2205, B2571008 |
| Study First Received: | August 13, 2009 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 QS 21 Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013