Alzheimer's Disease
Conditions
Keywords
Mild to moderate Alzheimer's disease, immunization, amyloid imaging, injection, vaccine
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.
Interventions
BIOLOGICALACC-001 (vanutide cridificar)
Comparisons of 2 different doses of ACC-001 or placebo for 24 months
Sponsors
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 89 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 disease biomarkers. | 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 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 | — |
Countries
United States
Outcome results
None listed