Clinical trial NCT01284387: Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Mild to moderate Alzheimer's disease
immunization
amyloid imaging
injection
vaccine
Lead sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2011-01-27
Enrollment: 126
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 24 Months
Secondary outcomes:
measure: 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.
timeFrame: 24 Months
measure: Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in disease biomarkers.
timeFrame: 24 Months
measure: Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in measurements of immunogenicity.
timeFrame: 24 Months
measure: Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in cognitive and functional scales.
timeFrame: 24 Months
measure: Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in health outcome measures.
timeFrame: 24 Months
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Janssen AI Investigational Site
state: Arizona
city: La Jolla
country: United States
facility: Janssen AI Investigational Site
state: California
city: Long Beach
country: United States
facility: Janssen AI Investigational Site
state: California
city: Los Angeles
country: United States
facility: Janssen AI Investigational Site
state: California
city: Oxnard
country: United States
facility: Janssen AI Investigational Site
state: California
city: San Diego
country: United States
facility: Janssen AI Investigational Site
state: California
city: San Francisco
country: United States
facility: Janssen AI Investigational Site
state: California
city: Washington
country: United States
facility: Janssen AI Investigational Site
state: District of Columbia
city: Miami
country: United States
facility: Janssen AI Investigational Site
state: Florida
city: Miami
country: United States
facility: Janssen AI Investigational Site
state: Florida
city: Ocala
country: United States
facility: Janssen AI Investigational Site
state: Florida
city: Orlando
country: United States
facility: Janssen AI Investigational Site
state: Florida
city: Sunrise
country: United States
facility: Janssen AI Investigational Site
state: Florida
city: Tampa
country: United States
facility: Janssen AI Investigational Site
state: Florida
city: Tampa
country: United States
facility: Janssen AI Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Janssen AI Investigational Site
state: Florida
city: Scarborough
country: United States
facility: Janssen AI Investigational Site
state: Maine
city: Boston
country: United States
facility: Janssen AI Investigational Site
state: Massachusetts
city: Kansas City
country: United States
facility: Janssen AI Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Janssen AI Investigational Site
state: Nevada
city: Princeton
country: United States
facility: Janssen AI Investigational Site
state: New Jersey
city: Albany
country: United States
facility: Janssen AI Investigational Site
state: New York
city: New York
country: United States
facility: Janssen AI Investigational Site
state: New York
city: Centerville
country: United States
facility: Janssen AI Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Janssen AI Investigational Site
state: Oklahoma
Study officials:
References:
citation: Ketter N, Liu E, Di J, Honig LS, Lu M, Novak G, Werth J, LePrince Leterme G, Shadman A, Brashear HR. A Randomized, Double-Blind, Phase 2 Study of the Effects of the Vaccine Vanutide Cridificar with QS-21 Adjuvant on Immunogenicity, Safety and Amyloid Imaging in Patients with Mild to Moderate Alzheimer's Disease. J Prev Alzheimers Dis. 2016;3(4):192-201. doi: 10.14283/jpad.2016.118.