Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease
This study has been completed.
Sponsor:
Pfizer
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
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
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 May 22, 2013