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

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NCT00752232

Last updated on November 12, 2019
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Study Location
Suwa Red Cross Hospital
Suwa, Nagano, 392-8510 Japan
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Contact
1-800-718-1021
[email protected]
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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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Descriptive Information
Brief Title  ICMJE Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease
Official Title  ICMJE 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.
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *Arai H, Suzuki H, Yoshiyama T. Vanutide cridificar and the QS-21 adjuvant in Japanese subjects with mild to moderate Alzheimer's disease: results from two phase 2 studies. Curr Alzheimer Res. 2015;12(3):242-54.


*   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: September 12, 2008)		40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion DateJuly 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00752232
Other Study ID Numbers  ICMJE 3134K1-2202
B2571006 ( Other Identifier: Alias Study 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 Research & 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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