A Long Term Extension Study Evaluating ACC-001 With QS-21 in 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:
NCT00960531
First received: August 13, 2009
Last updated: January 29, 2014
Last verified: January 2014

August 13, 2009
January 29, 2014
July 2009
December 2013   (final data collection date for primary outcome measure)
Incidence and severity of treatment emergent adverse events. Clinically important changes in safety assessment results. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00960531 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease
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

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate Alzheimer's disease.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer Disease
Drug: ACC-001+ QS21
IM injection, ACC-001(3mcg, or 10mcg, or 30mcg) + QS-21 50 mcg at Day 1 and weeks 26, 52, and 78
1
ACC-001 + QS-21
Intervention: Drug: ACC-001+ QS21
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects randomized under previous 3134K1-2201 study (NCT00498602) 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 greater than or equal to 10.

Other criteria apply.

Exclusion Criteria:

Significant Neurological Disease other than Alzheimer's disease.

Current clinically significant systemic illness.

Other exclusion criteria apply.

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00960531
3134K1-2205, B2571008
Yes
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

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