- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00498602
Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
November 30, 2015 updated by: Pfizer
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
To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in subjects with mild to moderate Alzheimer's disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85006
- Banner Alzheimer's Institute
-
Phoenix, Arizona, United States, 85006
- Banner Good Samaritan Medical Center
-
Sun City, Arizona, United States, 85351
- Banner Boswell Medical Center
-
Sun City, Arizona, United States, 85351
- Sun Health Research Institute
-
-
California
-
San Francisco, California, United States, 94158
- University of California, San Francisco
-
San Francisco, California, United States, 94118
- 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
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Yale University School of Medicine
-
New Haven, Connecticut, United States, 06511
- Yale-New Haven Hospital
-
New Haven, Connecticut, United States, 06509
- General Clinical Research Center
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- General Clinical Research Center
-
Washington, District of Columbia, United States, 20057
- GUMC
-
-
Florida
-
Hallandale Beach, Florida, United States, 33009
- MD Clinical
-
West Palm Beach, Florida, United States, 33407
- Palm Beach Neurology - Premiere Research Institute
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Missouri
-
St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
St. Louis, Missouri, United States, 63108
- Washington University School of Medicine
-
St. Louis, Missouri, United States, 63108
- Barnes-Jewish Hospital
-
St. Louis, Missouri, United States, 63110
- Barrnes-Jewish Hospital at Washington University
-
-
New Jersey
-
Eatontown, New Jersey, United States, 07724
- Memory Enhancement Center of America, Inc.
-
Edison, New Jersey, United States, 08837
- Pharmcare USA
-
-
New York
-
New York, New York, United States, 10032
- CUMC Research Pharmacy
-
New York, New York, United States, 10032
- Columbia Univ/Taub Institute Irving Ctr for Clinical Researc
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- Butler Hospital
-
-
Vermont
-
Bennington, Vermont, United States, 05201
- The Memory Clinic
-
Bennington, Vermont, United States, 05201
- The Pharmacy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
ACC-001
|
IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52
|
Other: 2
QS-21
|
IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52
|
Other: 3
Diluent: Phosphate Buffered Saline
|
IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52
|
Experimental: 4
ACC-001
|
IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
|
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.
|
Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
|
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
|
Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
July 9, 2007
First Submitted That Met QC Criteria
July 9, 2007
First Posted (Estimate)
July 10, 2007
Study Record Updates
Last Update Posted (Estimate)
January 1, 2016
Last Update Submitted That Met QC Criteria
November 30, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3134K1-2201
- B2571005 (Other Identifier: Alias Study Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
Clinical Trials on ACC-001 + QS-21
-
PfizerJANSSEN Alzheimer Immunotherapy Research & Development, LLCTerminatedAlzheimer DiseaseUnited States
-
PfizerJanssen Alzheimer Immunotherapy (JAI) Research and Development, LLCCompletedAlzheimer DiseaseSpain, France, Germany
-
PfizerJANSSEN Alzheimer Immunotherapy Research & Development, LLCCompletedAlzheimer's DiseaseUnited States
-
PfizerJANSSEN Alzheimer Immunotherapy Research & Development, LLCCompleted
-
PfizerJANSSEN Alzheimer Immunotherapy Research & Development, LLCCompletedAlzheimer DiseaseJapan
-
PfizerJANSSEN Alzheimer Immunotherapy Research & Development, LLCCompletedAlzheimer DiseaseSpain, France, Germany
-
PfizerJANSSEN Alzheimer Immunotherapy Research & Development, LLCTerminated
-
University of Kansas Medical CenterTargovax ASANot yet recruiting
-
National Cancer Institute (NCI)CompletedFollicular Lymphoma | B Cell Lymphoma | NeoplasmUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingNeuroblastoma | High-risk Neuroblastoma | Metastatic NeuroblastomaUnited States