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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Meitetsu Hospital
Aichi, , 451-8511 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's 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

- Mini-Mental State Examination (MMSE) 16-26

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

- Clinically significant systemic illness

NCT00959192
Pfizer
Completed
Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease

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Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant-controlled, Multiple Ascending Dose, Safety, Tolerability, And Immunogenicity Trial Of Acc-001 Withqs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease.
The purpose of this study is to assess the safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, in subjects with mild to moderate Alzheimer's disease in Japan.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Biological: ACC-001
    IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
  • Other: QS-21
    IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12
  • Other: QS-21
    IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
  • Experimental: ACC-001 + QS-21
    Active vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
    Interventions:
    • Biological: ACC-001
    • Other: QS-21
  • Placebo Comparator: QS-21
    Adjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
    Intervention: Other: QS-21
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of mild to moderate Alzheimer's Disease
  • Mini-Mental State Examination (MMSE) 16-26

Exclusion Criteria:

  • Significant Neurological Disease other than Alzheimer's disease
  • Major psychiatric disorder
  • Clinically significant systemic illness
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00959192
3134K1-2206
B2571009 ( 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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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