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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01284387

Run by

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

People needed

126

Starts

2011-01-01

Expected to finish

2014-02-01

Last updated by the study team

2015-01-05

Who can join

Age: 50 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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