Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Interventions
- Biological: ACC-001 (vanutide cridificar)
- Registration Number
- NCT01284387
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 μg ACC-001 / QS-21 50 μg IM dose 1 ACC-001 (vanutide cridificar) 3 μg ACC-001 / QS-21 50 μg IM 10 μg ACC-001 / QS-21 50 μg IM dose 2 ACC-001 (vanutide cridificar) 10 μg ACC-001 / QS-21 50 μg IM
- Primary Outcome Measures
Name Time Method 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. 24 Months
- Secondary Outcome Measures
Name Time Method 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 As assessed by:
* The incidence and severity of treatment-emergent adverse events (TEAEs); and
* Clinically important changes in safety assessment results (vital signs, weight, clinical laboratory tests, electrocardiograms \[ECGs\], brain magnetic resonance imaging \[MRIs\], and physical and neurological examinations).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
Trial Locations
- Locations (1)
Janssen AI Investigational Site
🇺🇸Oklahoma City, Oklahoma, United States