- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Researchers Choose Solanezumab for Alzheimer’s Disease (A4) Prevention Trial
First time an amyloid-clearing drug is tested in presymptomatic patients (Jan. 18)
Researchers at Brigham and Women's Hospital in Boston, Mass., have announced the selection of solanezumab (Eli Lilly) as the first therapeutic drug to be evaluated in the highly anticipated Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) prevention clinical trial. This is the first time investigators will test an amyloid-clearing drug in older individuals thought to be in the presymptomatic stage of Alzheimer’s disease (AD). The trial will enroll older individuals with evidence of amyloid in their brains — a hallmark of AD — but who do not show clinical symptoms of the disease. The study is funded by the National Institutes of Health (NIH) and by private-sector contributions.
The A4 study will enroll 1,000 patients, aged 70 to 85 years, who have evidence of the abnormal amyloid protein building up in the brain, as detected on positron emission tomography (PET) scans. The trial will be facilitated by the Alzheimer's Disease Cooperative Study (ADCS), a consortium of academic AD clinical trial centers. The ADCS was established by the NIH in 1991 to advance research on the treatment of AD.
The A4 researchers also announced that they will use Amyvid (florbetapir F18 injection, Avid Radiopharmaceuticals) as the PET amyloid tracer to select participants for the trial. Amyvid is an FDA-approved PET imaging agent for detecting the presence or absence of amyloid in the brains of patients with cognitive impairment who are being evaluated for AD and other causes of cognitive decline.
Solanezumab is a monoclonal antibody currently in phase III clinical trials. The drug binds to soluble monomeric forms of the amyloid beta protein, allowing the protein to be cleared before it clumps together to form plaques.
Source: Brigham and Women’s Hospital; January 18, 2013.