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

This study has been completed.
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00752232
First received: September 11, 2008
Last updated: August 28, 2012
Last verified: August 2012

September 11, 2008
August 28, 2012
December 2008
July 2012   (final data collection date for primary outcome measure)
  • Incidence and severity of Treatment Emergent Adverse Events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Clinically important changes in safety assessment results, including AEs, vital signs, weight, laboratory tests, electrocardiograms (ECGs), MRI, physical and neurological examinations [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Adverse Events and Tolerability [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00752232 on ClinicalTrials.gov Archive Site
  • Anti-a-beta IgG and IgM titer, and IgG subtype titer if applicable, at specified visits [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Changes of ADAS-Cog, DAD, NTB and MMSE scores from baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Cognitive and functional measures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease
A Phase IIa, Multicenter, Randomized, Third-Party Unblinded, Adjuvant And Placebo Controlled, Multiple Ascending Dose, Safety, Tolerability, And Immunogenicity Trial Of ACC-001 With 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00752232
3134K1-2202, B2571006
Yes
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP