NCT01284387CompletedPhase 2
A Phase 2, 24-Month, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Amyloid-Imaging Positron Emission Tomography (PET) and Safety Study of ACC-001 and QS-21 Adjuvant in Subjects With Mild to Moderate Alzheimer's Disease
JANSSEN Alzheimer Immunotherapy Research & Development, LLC26 sites in 1 country126 target enrollmentStarted: January 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 126
- Locations
- 26
- Primary Endpoint
- To evaluate the effect of ACC-001 in combination with an adjuvant immunostimulatory agent (QS-21), administered intramuscularly compared to placebo on cerebral amyloid burden in subjects with mild to moderate Alzheimer's disease.
Study Overview
Brief Summary
A Phase II clinical research study to evaluate the efficacy and safety of two different dose levels of an injectable investigational treatment (ACC-001) in subjects with Mild-to-Moderate Alzheimer's disease. ACC-001 (vanutide cridificar) is a beta amyloid fragment attached to a carrier protein. It is intended to help induce an antibody response against beta amyloid and is administered as an intramuscular injection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of probable AD
- •Age from 50 to 89
- •Mini-Mental Status Exam score of 18-26 inclusive
- •Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
- •Stable doses of medications (cholinesterase inhibitors and memantine allowed)
- •Caregiver able to attend all clinic visits with patient
- •Amyloid burden on screening PET scan consistent with diagnosis of AD
Exclusion Criteria
- •Significant neurological disease other than AD
- •Major psychiatric disorder
- •Significant systemic illness
- •History of stroke, seizure or autoimmune disease
- •History of myocardial infarction within the last 2 years
- •Smoking greater than 20 cigarettes per day
- •Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications (anticonvulsants used for non-seizure reasons are allowed)
- •Prior treatment experimental immunotherapeutics or vaccines for AD
- •Women of childbearing potential
- •Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body
Outcomes
Primary Outcomes
To evaluate the effect of ACC-001 in combination with an adjuvant immunostimulatory agent (QS-21), administered intramuscularly compared to placebo on cerebral amyloid burden in subjects with mild to moderate Alzheimer's disease.
Time Frame: 24 Months
Secondary Outcomes
- To evaluate the safety and tolerability of 2 dosage levels of ACC-001 plus QS-21 vs. placebo in subjects with mild to moderate AD.(24 Months)
- Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in measurements of immunogenicity.(24 Months)
- Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in disease biomarkers.(24 Months)
- Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in cognitive and functional scales.(24 Months)
- Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in health outcome measures.(24 Months)
Investigators
Study Sites (26)
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