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
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

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, electrocardiograms (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: 40
Study Start Date: December 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (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, 30 micrograms, Day 1, month 3, 6, 9, 12
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
Experimental: ACC-001
Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
Biological: ACC-001
IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
Placebo Comparator: QS-21
Adjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
Other: QS-21
IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
Placebo Comparator: PBS
Placebo, IM injection, Day 1, month 3, 6, 9, 12
Other: PBS
IM injection, Day 1, month 3, 6, 9, 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 Status Exam (MMSE) of 16-26

Exclusion Criteria:

  • Significant Neurological Disease
  • Major Psychiatric Disorder
  • Clinically significant systemic illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752232

Locations
Japan
Pfizer Investigational Site
Suwa, Nagano, Japan
Pfizer Investigational Site
Takatsuki, Osaka, 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: NCT00752232     History of Changes
Other Study ID Numbers: 3134K1-2202, B2571006
Study First Received: September 11, 2008
Last Updated: August 28, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
Phase IIa
multiple ascending dose study of ACC-001

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 April 23, 2014