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

Last updated on December 17, 2017

FOR MORE INFORMATION
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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Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
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
To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, 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
  • 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
  • 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
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
160
February 2013
February 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00498602
3134K1-2201
B2571005 ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & 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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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