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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Alzheimer's Disease

Treatments: Biological: ACC-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT01238991

3134K1-2207 (Other Identifier)

B2571001

Details and patient eligibility

About

The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies.

Enrollment: 53 patients

Sex: All

Ages: 52 to 87 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria.
• Screening brain MRI scan is consistent with the diagnosis of AD.
• MMSE score 10 and above.

Exclusion criteria

• Significant neurological diseases other than AD.
• Brain MRI evidence of vasogenic edema during the preceding studies.
• Clinically significant illness.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 3 patient groups

ACC-001 (3 micrograms) + QS-21

Experimental group

Description:

Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18

Treatment:

Biological: ACC-001

Biological: ACC-001

Biological: ACC-001

ACC-001 (10 micrograms) + QS-21

Experimental group

Description:

Active vaccine dose of 10 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18

Treatment:

Biological: ACC-001

Biological: ACC-001

Biological: ACC-001

ACC-001 (30 micrograms) + QS-21

Experimental group

Description:

Active vaccine dose of 30 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18

Treatment:

Biological: ACC-001

Biological: ACC-001

Biological: ACC-001