Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

Pfizer

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Biological: ACC-001(30µg) + QS21; Biological: ACC-001(3µg) + QS21; Biological: ACC-001(10µg) + QS21

Study type: Interventional

Funder types: Industry

Identifiers

NCT00955409

B2571007 (Other Identifier)

2009-010922-21 (EudraCT Number)

3134K1-2203

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 3 patient groups

ACC-001(3µg) + QS21

Experimental group

Description:

ACC-001(3µg) + QS21

Treatment:

Biological: ACC-001(3µg) + QS21

ACC-001(10µg) + QS21

Experimental group

Description:

ACC-001(10µg) + QS21

Treatment:

Biological: ACC-001(10µg) + QS21

ACC-001(30µg) + QS21

Experimental group

Description:

ACC-001(30µg) + QS21

Treatment:

Biological: ACC-001(30µg) + QS21