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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 October 10, 2019

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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Descriptive Information
Brief Title  ICMJE Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Official Title  ICMJE 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
Brief SummaryTo assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.
Detailed DescriptionNot 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 + 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
Study Arms  ICMJE
  • 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
Publications *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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2013)
86
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2007)
56
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion DateJanuary 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 France,   Germany,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00479557
Other Study ID Numbers  ICMJE 3134K1-200
B2571004 ( Other Identifier: Alias Study Number )
2006-002061-39 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2015

ICMJE     Data element required by the

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

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