RSS Feed Print
The A4 Study
Uncharted Waters
Posted: Friday, March 21, 2014 3:54 PM
Joined: 12/30/2013
Posts: 229

(I copied the info from the site so you don't have to click the link unless you are interested)

What is the A4 study?

The purpose of the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study (the”A4 study” for short) is to test whether a new investigational treatment, called an amyloid antibody, can slow memory loss caused by Alzheimer’s disease. Amyloid is a protein normally produced in the brain that can build up in older people, forming amyloid plaque deposits. Scientists believe this buildup of deposits may play a key role in the eventual development of Alzheimer’s disease-related memory loss. The overall goal of the A4 study is to test whether decreasing amyloid with antibody investigational treatment can help slow the memory loss associated with amyloid buildup in some people. 

The A4 study invites older individuals (ages 65-85) who have normal thinking and memory function but who may be at risk for memory loss due to Alzheimer’s disease, but have no outward signs of the disease to participate in the study. We seek to enroll 1,000 adults who have an “elevated” level of amyloid plaque in their brain. Physicians and researchers will use an imaging test called a PET scan to determine whether a potential participant has evidence of this plaque buildup. People who do not show evidence of elevated amyloid in their brains will not be able to participate, but may be asked to participate in a separate study. This group will not receive the investigational drug or placebo (i.e., an inactive substance designed to mimic the appearance of a drug), but will complete the same memory tests every six months to compare changes in cognition over time.

The A4 study lasts for three years, and participants will be required to visit the clinical research site once a month. Participants will be assigned at random to receive either the investigational drug or a placebo and will be monitored over the course of the three years. All clinical studies, including the A4 study, may involve some risks associated with participation. If you are considering participating in A4, you will have detailed discussions with physicians and research staff regarding the investigational treatment and other aspects of the A4 study. 

Who is sponsoring the study?

The A4 study is a landmark public-private partnership, funded by the National Institute on Aging, Eli Lilly and Company, and several philanthropic organizations. The A4 study is coordinated by the Alzheimer's Disease Cooperative Study, located at the University of California, San Diego.

Eligibility Requirements

Like most clinical trials, the A4 study has very specific eligibility requirements. You may be eligible to join the A4 study if you:
Are 65 to 85 years old
Have normal thinking and memory abilities
Have an A4 study partner – someone who has at least weekly contact with you who can answer questions once a year
Are willing and able to receive IV infusions of the investigational treatment or placebo for 36 months (36 monthly infusions); all A4 participants must be willing and able to participate in all required procedures for the duration of the A4 study.
Are willing to have your health monitored throughout the study using assessments such as:
Memory and thinking tests
ECGs (a look at your heart)
PET scan (a way to look for the plaques thought to be associated with AD)
MRI scans (a way to take a picture of your brain)
Blood and urine tests

Unfortunately, the A4 study is not for everyone. You are not eligible to join the A4 study if you:

Receive treatment for Alzheimer's disease or are taking AD-related medications
Are diagnosed with a current serious or unstable illness
Reside in a skilled nursing facility or nursing home