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A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease

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NCT00960531

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Banner Alzheimer's Institute
Phoenix, Arizona, 85006 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Subjects randomized under previous 3134K1-2201 study (NCT00498602) and met all

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00960531
Pfizer
Terminated
A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease

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A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer Disease
  • Biological: ACC-001+ QS21 (3mcg)
    ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
  • Biological: ACC-001 (10 mcg) + QS-21
    ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
  • Biological: ACC-001+QS-21 (30mcg)
    ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
  • Experimental: ACC-001 (3mcg) + QS-21
    ACC-001 (3mcg) + QS-21
    Intervention: Biological: ACC-001+ QS21 (3mcg)
  • Experimental: ACC-001 (10mcg) + QS-21
    ACC-001 (10mcg) + QS-21
    Intervention: Biological: ACC-001 (10 mcg) + QS-21
  • Experimental: ACC-001 (30mcg) + QS-21
    ACC-001 (30mcg) + QS-21
    Intervention: Biological: ACC-001+QS-21 (30mcg)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
160
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00960531
3134K1-2205
B2571008 ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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