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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Groupe Hospitalier Pitie-Salpetriere
Paris, Cedex 13 (MRI), 75651 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
50-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE)
score of 16-26 (except Germany: 21-26)

- Brain MRI consistent with Alzheimer Disease

- Concurent use of Chloniesterase inhibitor or memantine allowed if stable

- Other inclusion 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

- Major psychiatric disorder

- Contraindication to undergo brain MRI

- Clinically significant systemic illness

- Other exclusion criteria apply

NCT00479557
Pfizer
Completed
Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

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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, 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 Alzheimer's Disease
To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients 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 + QS-21
    Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
  • Biological: ACC-001
    Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12
  • Biological: QS-21
    QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
  • Drug: Placebo: Phosphate buffered saline
    Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12
  • Active Comparator: 1
    arm 1: ACC-001 (Vanutide Cridificar)+ QS-21
    Intervention: Biological: ACC-001 + QS-21
  • Active Comparator: 2
    arm 2: ACC-001
    Intervention: Biological: ACC-001
  • Placebo Comparator: 3
    arm 3: QS-21
    Intervention: Biological: QS-21
  • Placebo Comparator: 4
    Drug: Phosphate Buffered Saline (PBS)
    Intervention: Drug: Placebo: Phosphate buffered saline
Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
January 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)
  • Brain MRI consistent with Alzheimer Disease
  • Concurent use of Chloniesterase inhibitor or memantine allowed if stable
  • Other inclusion criteria apply

Exclusion Criteria:

  • Significant Neurological Disease other than Alzheimer's disease
  • Major psychiatric disorder
  • Contraindication to undergo brain MRI
  • 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
France,   Germany,   Spain
 
 
NCT00479557
3134K1-200
B2571004 ( Other Identifier: Alias Study Number )
2006-002061-39 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2015

ICMJE     Data element required by the

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

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1-800-718-1021

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