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

Alzheimer's Disease Clinical Trial

— ACCTION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284387
• Other study ID #: ACC-001-ALZ-2001
• Status: Completed
• Phase: Phase 2
• First received: January 20, 2011
• Last updated: December 11, 2014
• Start date: January 2011
• Est. completion date: February 2014

Study information

• Verified date: December 2014
• Source: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 89 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• ACC-001 (vanutide cridificar)
Comparisons of 2 different doses of ACC-001 or placebo for 24 months

Locations

Country	Name	City	State
United States	Janssen AI Investigational Site	Albany	New York
United States	Janssen AI Investigational Site	Boston	Massachusetts
United States	Janssen AI Investigational Site	Centerville	Ohio
United States	Janssen AI Investigational Site	Kansas City	Missouri
United States	Janssen AI Investigational Site	La Jolla	California
United States	Janssen AI Investigational Site	Las Vegas	Nevada
United States	Janssen AI Investigational Site	Long Beach	California
United States	Janssen AI Investigational Site	Los Angeles	California
United States	Janssen AI Investigational Site	Miami	Florida
United States	Janssen AI Investigational Site	Miami	Florida
United States	Janssen AI Investigational Site	New York	New York
United States	Janssen AI Investigational Site	Ocala	Florida
United States	Janssen AI Investigational Site	Oklahoma City	Oklahoma
United States	Janssen AI Investigational Site	Orlando	Florida
United States	Janssen AI Investigational Site	Oxnard	California
United States	Janssen AI Investigational Site	Princeton	New Jersey
United States	Janssen AI Investigational Site	San Diego	California
United States	Janssen AI Investigational Site	San Francisco	California
United States	Janssen AI Investigational Site	Scarborough	Maine
United States	Janssen AI Investigational Site	Sun City	Arizona
United States	Janssen AI Investigational Site	Sunrise	Florida
United States	Janssen AI Investigational Site	Tampa	Florida
United States	Janssen AI Investigational Site	Tampa	Florida
United States	Janssen AI Investigational Site	Washington	District of Columbia
United States	Janssen AI Investigational Site	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
JANSSEN Alzheimer Immunotherapy Research & Development, LLC	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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).	24 Months	Yes
Secondary	Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in disease biomarkers.		24 Months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No