Trial record 6 of 9 for:
acc-001
Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00955409
First received: August 4, 2009
Last updated: May 14, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, in subjects with mild to moderate Alzheimer's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: ACC-001+ QS21 Drug: ACC-001 Drug: ACC-001 + QS21 |
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, Long-Term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of ACC-001 With QS-21 Adjuvant In 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; clinically important changes in safety assessment results including adverse events , vital signs, weight, clinical laboratory tests, ECGs, MRI scans, and physical and neurological examinations. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from baseline levels of anti-A-beta IgG, Anti-A-beta IgM and IgG subclass antibody levels at selected time points. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
ACC-001(3µg) + QS21
|
Drug: ACC-001+ QS21
Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
|
|
2
ACC-001(10µg) + QS21
|
Drug: ACC-001
Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
|
|
3
ACC-001(30µg) + QS21
|
Drug: ACC-001 + QS21
Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects randomized under previous 3134K1-200 study (NCT00479557) and met all inclusion/and none of the exclusion criteria
- Screening brain MRI scan is consistent with the diagnosis of AD ' Mini-Mental State Examination (MMSE) score =10
Exclusion Criteria:
- Significant Neurological Disease other than Alzheimer's disease
- Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)
- Clinically significant systemic illness
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955409
Locations
| France | |
| Pfizer Investigational Site | |
| Bordeaux, France, 33076 | |
| Pfizer Investigational Site | |
| Lille, France, 59037 | |
| Pfizer Investigational Site | |
| Marseille cedex 5, France, 13385 | |
| Pfizer Investigational Site | |
| Paris, France, 75013 | |
| Pfizer Investigational Site | |
| Paris Cedex 13, France, 75651 | |
| Pfizer Investigational Site | |
| Toulouse cedex 9, France, 31059 | |
| Germany | |
| Pfizer Investigational Site | |
| Berlin, Germany, 14050 | |
| Pfizer Investigational Site | |
| Bonn, Germany, 53127 | |
| Pfizer Investigational Site | |
| Bonn, Germany, 48129 | |
| Pfizer Investigational Site | |
| Freiburg, Germany, 79106 | |
| Pfizer Investigational Site | |
| Goettingen, Germany, 37075 | |
| Pfizer Investigational Site | |
| Mannheim, Germany, 68159 | |
| Pfizer Investigational Site | |
| Munich, Germany, 81675 | |
| Spain | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08036 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08003 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08025 | |
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: | NCT00955409 History of Changes |
| Other Study ID Numbers: | 3134K1-2203, B2571007 |
| Study First Received: | August 4, 2009 |
| Last Updated: | May 14, 2013 |
| Health Authority: | European Union: EMA France: AFSSAPS Germany: Paul-Ehrlich-Institut Spain: Min of Health |
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 16, 2013