Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease

Pfizer

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00752232

B2571006 (Other Identifier)

3134K1-2202

Details and patient eligibility

About

The study is to evaluate the safety, tolerability and whether there is an immune system response to multiple doses of ACC-001 with or without the use of a substance that may increase the response to the drug.

Enrollment: 40 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 Status Exam (MMSE) of 16-26

Exclusion criteria

• Significant Neurological Disease
• Major Psychiatric Disorder
• Clinically significant systemic illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups, including a placebo group

ACC-001+QS-21

Experimental group

Description:

Active vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12

Treatment:

Other: QS-21

Other: QS-21

Biological: ACC-001

Biological: ACC-001

ACC-001

Experimental group

Description:

Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12

Treatment:

Biological: ACC-001

Biological: ACC-001

QS-21

Placebo Comparator group

Description:

Adjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12

Treatment:

Other: QS-21

Other: QS-21

PBS

Placebo Comparator group

Description:

Placebo, IM injection, Day 1, month 3, 6, 9, 12

Treatment:

Other: PBS