A first-in-human, phase I study of the safety of an intramuscular vaccine against beta-amyloid in persons with mild-to-moderate Alzheimer’s disease

The goal of this Phase I, double-blind, randomized, placebo-controlled study is to determine a safe and tolerable dose of a new vaccine against beta-amyloid, a protein that seems to be involved in the development of Alzheimer’s disease. The vaccine presents a form of the beta-amyloid protein along with other agents that stimulate the body to produce antibodies against beta-amyloid. This study is the first clinical trial of this vaccine in humans.

The study, which is being conducted by the Rush Alzheimer’s Disease Center (one of the 13 sites around the world), is sponsored and funded by Merck & Co., Inc.

Duration of the study is 42 months. Eligible participants will have an 80 percent chance of receiving a vaccine formulation with V950 and a 20 percent chance of receiving placebo. Vaccine will be given intramuscularly at baseline, two months, and six months.

Each clinic visit will be a combination of all or some of the following: memory testing; neurological exams, blood, urine, and/or spinal fluid collection; electrocardiograms (ECGs) as well as close monitoring for side effects that may occur with the administration of the vaccine.

There will be no cost to people who join the study. The study vaccine and all visits will be covered by the research study.

You may be eligible to participate in this study if you:

• Are at least 55 years of age
• Have a diagnosis of mild to moderate Alzheimer’s disease [a Mini-Mental State Examination (MMSE) Score between 18 and 26]
• Are otherwise healthy and on stable doses of all medications for at least three months
• Speak English
• Have a friend or family member who will accompany the subject to all study visits

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.