Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects 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:
NCT00959192
First received: August 13, 2009
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Biological: ACC-001
Other: QS-21
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIA, Multicenter, Randomized, Third-Party Unblinded, Adjuvant-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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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, ECGs, MRI, physical and neurological examinations [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: August 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Placebo Comparator: QS-21
Adjuvant, IM injection, dose 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

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959192

Locations
Japan
Pfizer Investigational Site
Aichi, Japan
Pfizer Investigational Site
Ibaraki, Japan
Pfizer Investigational Site
Kanagawa, Japan
Pfizer Investigational Site
Osaka, Japan
Pfizer Investigational Site
Tokyo, Japan
Sponsors and Collaborators
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00959192     History of Changes
Other Study ID Numbers: 3134K1-2206, B2571009
Study First Received: August 13, 2009
Last Updated: February 6, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
QS 21
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014