Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's Disease

JANSSEN Alzheimer Immunotherapy Research & Development, LLC126 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

126

Conditions

Alzheimer's Disease

Interventions

ACC-001 (vanutide cridificar)BIOLOGICAL

Comparisons of 2 different doses of ACC-001 or placebo for 24 months

Eligibility

Sex: ALLMin age: 50 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (25)

Janssen AI Investigational Site

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.

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).

Time frame: 24 Months

Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in disease biomarkers.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 24 Months

Data from ClinicalTrials.gov

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