Avid Radiopharmaceuticals, Inc. has announced the start of a Phase II clinical trial studying 18F-AV-45, an investigational molecular imaging compound under development for imaging Alzheimer’s disease.
18F-AV-45 is used with positron emission tomography (PET) to allow visualization of the amyloid plaque deposits in the brain that are characteristic of Alzheimer’s disease.
Amyloid plaque is thought to slowly accumulate in patients over years, eventually causing death of brain cells and dementia. This is the first large scale multi-center trial of an 18F-labeled PET molecular imaging agent for visualizing amyloid plaques.
“The initiation of this study is a major milestone for Avid and what will be a major advance for the field of molecular imaging,” said Daniel Skovronsky, president and CEO of Avid. “This is just the beginning of our efforts to develop molecular imaging agents to make personalized medicine a reality for patients dealing with the devastating effects of dementia.”
The ability to image amyloid deposits with 18F-AV-45 has the potential to facilitate early and accurate diagnosis in patients with symptoms of memory loss.
Currently available diagnostic criteria for probable Alzheimer’s disease are used relatively late in the disease course, and provide accurate diagnosis in only approximately 70-80 percent of patients. Because up to one third of patients with dementia do not have Alzheimer’s disease, it is critically important to accurately diagnose patients prior to planning treatment.
This U.S. Phase II clinical trial of 18F-AV-45 will enroll approximately 200 patients with varying degrees of memory loss at more than 30 centers across the country. The trial involves a single administration of 18F-AV-45 and a PET imaging procedure that is completed in less than one hour.
The study is designed to show how 18F-AV-45 imaging of amyloid plaque compares between healthy volunteers, patients with mild cognitive impairment, and patients with Alzheimer’s disease. This initial Phase II study is the first of several trials planned to study the effectiveness of this Avid molecular imaging agent in more than 500 patients worldwide.
This is the first large scale multi-center trial of an 18F-labeled PET molecular imaging agent for visualizing amyloid plaques. Previous PET imaging studies of amyloid plaque have involved the use of 11C-labeled radiopharmaceuticals which have a very short useful lifetime due to the short (20 minute) radioactive half-life of 11C.
On the other hand, 18F-AV-45 may be used over several hours after production due to the longer (two hour) half-life of 18F radiopharmaceuticals, making 18F-AV-45 practical for broader scale availability in the future.