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 + QS-21; Drug: Placebo: Phosphate buffered saline; Biological: ACC-001; Biological: QS-21

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00479557

2006-002061-39 (EudraCT Number)

3134K1-200

B2571004 (Other Identifier)

Details and patient eligibility

About

To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.

Enrollment: 86 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)
• Brain MRI consistent with Alzheimer Disease
• Concurent use of Chloniesterase inhibitor or memantine allowed if stable
• Other inclusion criteria apply

Exclusion criteria

• Significant Neurological Disease other than Alzheimer's disease
• Major psychiatric disorder
• Contraindication to undergo brain MRI
• 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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86 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

arm 1: ACC-001 (Vanutide Cridificar)+ QS-21

Treatment:

Biological: ACC-001 + QS-21

2

Active Comparator group

Description:

arm 2: ACC-001

Treatment:

Biological: ACC-001

3

Placebo Comparator group

Description:

arm 3: QS-21

Treatment:

Biological: QS-21

4

Placebo Comparator group

Description:

Drug: Phosphate Buffered Saline (PBS)

Treatment:

Drug: Placebo: Phosphate buffered saline