Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

Pfizer

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Biological: QS-21; Biological: ACC-001; Biological: ACC-001 + QS-21; Other: Diluent: Phosphate Buffered Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00498602

B2571005 (Other Identifier)

3134K1-2201

Details and patient eligibility

About

To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, 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

• Diagnosis of mild to moderate Alzheimer's disease
• Age 50-85
• Mini Mental State Examination (MMSE) 16-26 Other criteria apply

Exclusion criteria

• Significant Neurological Disease
• Major psychiatric disorder
• Clinically significant systemic illness Other exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

160 participants in 4 patient groups

1

Experimental group

Description:

ACC-001

Treatment:

Biological: ACC-001 + QS-21

2

Other group

Description:

QS-21

Treatment:

Biological: QS-21

3

Other group

Description:

Diluent: Phosphate Buffered Saline

Treatment:

Other: Diluent: Phosphate Buffered Saline

4

Experimental group

Description:

ACC-001

Treatment:

Biological: ACC-001