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Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
This study has been completed.
Sponsor:
Pfizer
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00498602
First received: July 9, 2007
Last updated: November 30, 2015
Last verified: November 2015
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Purpose
To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in subjects with mild to moderate Alzheimer's disease.
| Condition | Intervention | Phase |
|---|---|---|
| Alzheimer Disease | Biological: ACC-001 + QS-21 Biological: QS-21 Other: Diluent: Phosphate Buffered Saline Biological: ACC-001 | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability, And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimers 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:
- Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) [ Time Frame: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose ]An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Secondary Outcome Measures:
- Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ]The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.
- GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ]The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.
- Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable) [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ]IgG subtypes were not assessed
| Enrollment: | 160 |
| Study Start Date: | November 2007 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
ACC-001
|
Biological: ACC-001 + QS-21
IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52
|
|
2
QS-21
|
Biological: QS-21
IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52
|
|
3
Diluent: Phosphate Buffered Saline
|
Other: Diluent: Phosphate Buffered Saline
IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52
|
|
Experimental: 4
ACC-001
|
Biological: ACC-001
IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52
|
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of mild to moderate Alzheimer`s disease
- Age 50-85
- Mini Mental State Examination (MMSE) 16-26 Other criteria apply
Exclusion Criteria:
- Significant Neurological Disease
- Major psychiatric disorder
- Clinically significant systemic illness Other exclusion criteria apply.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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: NCT00498602
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498602
Locations
| United States, Arizona | |
| Banner Alzheimer's Institute | |
| Phoenix, Arizona, United States, 85006 | |
| Banner Good Samaritan Medical Center | |
| Phoenix, Arizona, United States, 85006 | |
| Banner Boswell Medical Center | |
| Sun City, Arizona, United States, 85351 | |
| Sun Health Research Institute | |
| Sun City, Arizona, United States, 85351 | |
| United States, California | |
| University of California - San Francisco | |
| San Francisco, California, United States, 94117 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94117 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94118 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94158 | |
| United States, Connecticut | |
| General Clinical Research Center | |
| New Haven, Connecticut, United States, 06509 | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
| Yale-New Haven Hospital | |
| New Haven, Connecticut, United States, 06511 | |
| United States, District of Columbia | |
| General Clinical Research Center | |
| Washington, District of Columbia, United States, 20007 | |
| GUMC | |
| Washington, District of Columbia, United States, 20057 | |
| United States, Florida | |
| MD Clinical | |
| Hallandale Beach, Florida, United States, 33009 | |
| Palm Beach Neurology - Premiere Research Institute | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Missouri | |
| Barnes-Jewish Hospital | |
| St. Louis, Missouri, United States, 63108 | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63108 | |
| Barrnes-Jewish Hospital at Washington University | |
| St. Louis, Missouri, United States, 63110 | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Memory Enhancement Center of America, Inc. | |
| Eatontown, New Jersey, United States, 07724 | |
| Pharmcare USA | |
| Edison, New Jersey, United States, 08837 | |
| United States, New York | |
| Columbia Univ/Taub Institute Irving Ctr for Clinical Researc | |
| New York, New York, United States, 10032 | |
| CUMC Research Pharmacy | |
| New York, New York, United States, 10032 | |
| United States, Rhode Island | |
| Butler Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Vermont | |
| The Memory Clinic | |
| Bennington, Vermont, United States, 05201 | |
| The Pharmacy | |
| 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00498602 History of Changes |
| Other Study ID Numbers: |
3134K1-2201 B2571005 ( Other Identifier: Alias Study Number ) |
| Study First Received: | July 9, 2007 |
| Results First Received: | April 23, 2014 |
| Last Updated: | November 30, 2015 |
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 July 17, 2017