A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960531
• Other study ID #: 3134K1-2205
• Secondary ID: B2571008
• Status: Completed
• Phase: Phase 2
• First received: August 13, 2009
• Last updated: January 29, 2014
• Start date: July 2009
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Bennington	Vermont
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Eatontown	New Jersey
United States	Pfizer Investigational Site	Hallandale Beach	Florida
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Providence	Rhode Island
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	Sun City	Arizona
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of treatment emergent adverse events. Clinically important changes in safety assessment results.		24 months	Yes

External Links

•   To obtain contact information for a study center near you, click here.