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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Alzheimer Disease

Treatments: Biological: ACC-001 (10 mcg) + QS-21; Biological: ACC-001+ QS21 (3mcg); Biological: ACC-001+QS-21 (30mcg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960531

3134K1-2205

B2571008 (Other Identifier)

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 vaccine, plus QS-21 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 3134K1-2201 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.

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 (3mcg) + QS-21

Experimental group

Description:

ACC-001 (3mcg) + QS-21

Treatment:

Biological: ACC-001+ QS21 (3mcg)

ACC-001 (10mcg) + QS-21

Experimental group

Description:

ACC-001 (10mcg) + QS-21

Treatment:

Biological: ACC-001 (10 mcg) + QS-21

ACC-001 (30mcg) + QS-21

Experimental group

Description:

ACC-001 (30mcg) + QS-21

Treatment:

Biological: ACC-001+QS-21 (30mcg)