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Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

Last updated on December 12, 2019

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Study Location
Banner Alzheimer's Institute
Phoenix, Arizona, 85006 United States
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 mild to moderate Alzheimer`s disease

- Age 50-85

- Mini Mental State Examination (MMSE) 16-26 Other criteria apply

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

- Significant Neurological Disease

- Major psychiatric disorder

- Clinically significant systemic illness Other exclusion criteria apply.

NCT00498602
Pfizer
Completed
Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

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Descriptive Information
Brief Title  ICMJE Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Official Title  ICMJE 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 Alzheimers Disease
Brief Summary To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, 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 + QS-21
    IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52
  • Biological: QS-21
    IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52
  • Other: Diluent: Phosphate Buffered Saline
    IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52
  • Biological: ACC-001
    IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52
Study Arms  ICMJE
  • Experimental: 1
    ACC-001
    Intervention: Biological: ACC-001 + QS-21
  • 2
    QS-21
    Intervention: Biological: QS-21
  • 3
    Diluent: Phosphate Buffered Saline
    Intervention: Other: Diluent: Phosphate Buffered Saline
  • Experimental: 4
    ACC-001
    Intervention: Biological: ACC-001
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: November 30, 2015)
160
Original Enrollment  ICMJE
 (submitted: July 9, 2007)
228
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of mild to moderate Alzheimer`s disease
  • Age 50-85
  • Mini Mental State Examination (MMSE) 16-26 Other criteria apply

Exclusion Criteria:

  • Significant Neurological Disease
  • Major psychiatric disorder
  • 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 NCT00498602
Other Study ID Numbers  ICMJE 3134K1-2201
B2571005 ( 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 Center Pfizer
PRS Account Pfizer
Verification Date November 2015

ICMJE     Data element required by the

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

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

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1-800-718-1021

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