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

Study Overview
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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.

Official Title
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A Phase 2a, Multicenter, Randomized, Third-party Un-blinded, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Biological: ACC-001+ QS21 (3mcg)
* Biological: ACC-001 (10 mcg) + QS-21
* Biological: ACC-001+QS-21 (30mcg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects randomized under previous 3134K1-2201 study (NCT00498602) and met all inclusion/and none of the 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. Exclusion Criteria: Significant Neurological Disease other than Alzheimer's disease. Current clinically significant systemic illness. Other exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACC-001 (3mcg) + QS-21<br>ACC-001 (3mcg) + QS-21 | Biological: ACC-001+ QS21 (3mcg)<br>* ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo<br>|
| Experimental: ACC-001 (10mcg) + QS-21<br>ACC-001 (10mcg) + QS-21 | Biological: ACC-001 (10 mcg) + QS-21<br>* ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo<br>|
| Experimental: ACC-001 (30mcg) + QS-21<br>ACC-001 (30mcg) + QS-21 | Biological: ACC-001+QS-21 (30mcg)<br>* ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | 24 months |