A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease
NCT00960531
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1-800-718-1021
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.
Significant Neurological Disease other than Alzheimer's disease.
Current clinically significant systemic illness.
Other exclusion criteria apply.
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Descriptive Information | ||||
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Brief Title ICMJE | A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease | |||
Official Title ICMJE | A Phase 2a, Multicenter, Randomized, Third-party Un-blinded, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer Disease | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Alzheimer Disease | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 160 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2013 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | 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. | |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 50 Years to 85 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00960531 | |||
Other Study ID Numbers ICMJE | 3134K1-2205 B2571008 ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | JANSSEN Alzheimer Immunotherapy Research & Development, LLC | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |