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Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Suwa Red Cross Hospital
Suwa, Nagano, 392-8510 Japan
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

- Mini Mental Status Exam (MMSE) of 16-26

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

NCT00752232
Pfizer
Completed
Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease

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Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease
A Phaseiia, 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 Japanese Subjects With Mild To Moderate Alzheimer's Disease.
The study is to evaluate the safety, tolerability and whether there is an immune system response to multiple doses of ACC-001 with or without the use of a substance that may increase the response to the drug.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer Disease
  • Biological: ACC-001
    IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
  • Other: QS-21
    IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
  • Other: PBS
    IM injection, Day 1, month 3, 6, 9, 12
  • Experimental: ACC-001+QS-21
    Active vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
    Interventions:
    • Biological: ACC-001
    • Other: QS-21
  • Experimental: ACC-001
    Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
    Intervention: Biological: ACC-001
  • Placebo Comparator: QS-21
    Adjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
    Intervention: Other: QS-21
  • Placebo Comparator: PBS
    Placebo, IM injection, Day 1, month 3, 6, 9, 12
    Intervention: Other: PBS
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2012
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Significant Neurological 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
 
 
NCT00752232
3134K1-2202
B2571006 ( 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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[email protected]



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