A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate Alzheimer's disease.

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Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ACC-001 (3mcg) + QS-21

Group Type EXPERIMENTAL

ACC-001+ QS21 (3mcg)

Intervention Type BIOLOGICAL

ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

ACC-001 (10mcg) + QS-21

Group Type EXPERIMENTAL

ACC-001 (10 mcg) + QS-21

Intervention Type BIOLOGICAL

ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

ACC-001 (30mcg) + QS-21

Group Type EXPERIMENTAL

ACC-001+QS-21 (30mcg)

Intervention Type BIOLOGICAL

ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

Interventions

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ACC-001+ QS21 (3mcg)

ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

Intervention Type BIOLOGICAL

ACC-001 (10 mcg) + QS-21

ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

Intervention Type BIOLOGICAL

ACC-001+QS-21 (30mcg)

ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Exclusion Criteria

Screening brain MRI scan is consistent with the diagnosis of AD.

Mini-Mental State Examination (MMSE) score greater than or equal to 10.

Other criteria apply.

Significant Neurological Disease other than Alzheimer's disease.

Current clinically significant systemic illness.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Banner Alzheimer's Institute

Phoenix, Arizona, United States

Site Status

Banner Boswell Medical Center

Sun City, Arizona, United States

Site Status