Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease

Wyeth

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: bapineuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00397891

3133K1-102

Details and patient eligibility

About

Evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational AAB-001 Vaccine in Japanese patients with Alzheimer's disease.

Enrollment: 80 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of AD
• Age 50-85
• MMSE 14-26
• Other Inclusion 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: Double Blind

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80 participants in 3 patient groups

1

Experimental group

Description:

bapineuzumab 0.15 mg/kg or placebo

Treatment:

Drug: bapineuzumab

Drug: bapineuzumab

Drug: bapineuzumab

2

Experimental group

Description:

bapineuzumab 0.5 mg/kg or placebo

Treatment:

Drug: bapineuzumab

Drug: bapineuzumab

Drug: bapineuzumab

3

Experimental group

Description:

bapineuzumab 1.0 mg/kg or placebo

Treatment:

Drug: bapineuzumab

Drug: bapineuzumab

Drug: bapineuzumab