Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease

Pfizer

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Other: QS-21; Biological: ACC-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT00959192

B2571009 (Other Identifier)

3134K1-2206

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of mild to moderate Alzheimer's Disease
• Mini-Mental State Examination (MMSE) 16-26

Exclusion criteria

• Significant Neurological Disease other than Alzheimer's disease
• Major psychiatric disorder
• Clinically significant systemic illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

ACC-001 + QS-21

Experimental group

Description:

Active vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12

Treatment:

Other: QS-21

Biological: ACC-001

Other: QS-21

QS-21

Placebo Comparator group

Description:

Adjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12

Treatment:

Other: QS-21

Other: QS-21