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Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bordeaux, , 33076 France
Contact
1-800-718-1021
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
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects randomized under previous 3134K1-200 study (NCT00479557) 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 =10

Exclusion Criteria:

- Significant Neurological Disease other than Alzheimer's disease

- Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study
(NCT00479557)

- Clinically significant systemic illness

NCT00955409
Pfizer
Completed
Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

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Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
A Phase IIa, Multicenter, Randomized, Third-Party Unblinded, Long-Term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of ACC-001 With QS-21 Adjuvant In Subjects With Mild To Moderate Alzheimer's Disease
The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, 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
  • Drug: ACC-001+ QS21
    Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
  • Drug: ACC-001
    Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
  • Drug: ACC-001 + QS21
    Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
  • 1
    ACC-001(3µg) + QS21
    Intervention: Drug: ACC-001+ QS21
  • 2
    ACC-001(10µg) + QS21
    Intervention: Drug: ACC-001
  • 3
    ACC-001(30µg) + QS21
    Intervention: Drug: ACC-001 + QS21
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects randomized under previous 3134K1-200 study (NCT00479557) 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 =10

Exclusion Criteria:

  • Significant Neurological Disease other than Alzheimer's disease
  • Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)
  • Clinically significant systemic illness
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Spain
 
 
NCT00955409
3134K1-2203
B2571007
Yes
Not Provided
Not Provided
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

ICMJE     Data element required by the

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

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

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Contact

[email protected]

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