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

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Study Location
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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


Significant Neurological Disease other than Alzheimer's disease.


Current clinically significant systemic illness.


Other exclusion criteria apply.

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Advanced Information
Descriptive Information
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
  • 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
Study Arms  ICMJE
  • 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)
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
 (submitted: August 14, 2009)		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
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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