The compound, called AV-45, is coupled with a PET scan to allow doctors to see inside patients’ brains to detect beta-amyloid plaques, the tell-tale signature of Alzheimer’s, according to a statement from Cleveland Clinic, which will conclude its annual medical innovation summit this afternoon. Currently, diagnosing Alzheimer’s is possible only through autopsy.
The Clinic annually releases its choices for the following year’s top medical innovations, which are selected by a group of its doctors and scientists. A removable hearing and communication device that treats patients who have lost hearing in one ear came in at No. 1 last year.
Cleveland Clinic doesn’t specifically name the companies or products that appear on the list, but that’s not much of a deterrent for someone with Internet access and a little patience. A quick search of “AV-45” reveals it’s been developed by Philadelphia-based Avid Radiopharmaceuticals.
Avid’s imaging compound, also known as florbetapir, hasn’t reached the market but is in the midst of Phase 3 clinical trials, so it could be ready for U.S. sales within a year or so. Dublin, Ohio-based Cardinal Health plays a role in the manufacturing of AV-45, (pdf) providing the raw materials needed to make the compound. Cardinal operates the largest network of radiopharmacies in the United States.
An Avid spokesman wasn’t immediately available for comment.
Cleveland Clinic said it evaluates four major criteria to make selections for the “Most Innovative” list. The technology must have significant potential for short-term clinical impact, a high probability of success, be on the market or close to being introduced, and have sufficient data to support its nomination.
Other medical innovations cited by the Clinic include a new test for diagnosing asthma, technology that allows for remote monitoring of heart-failure patients and a therapeutic cancer vaccine. Here’s the rest of this year’s Top 10, listed in descending order.
10. Capsule endoscopy for diagnosis of pediatric GI disorders: A pill-sized camera captures 50,000 high-resolution images during its painless six- to eight-hour journey through the digestive tract, proving better than X-ray at detecting small bowel ulcerations, polyps and areas of bleeding.
9. Oral disease-modifying treatment for multiple sclerosis: Before fingolimid was approved by the FDA this year, MS drugs had to be injected or infused on a regular basis. This oral medication stops T-cells from attacking the myelin sheaths that cover nerve fibers.
8. Exhaled nitric oxide (NO) breath analysis for diagnosing asthma: A new hand-held diagnostic testing device measures a patient’s level of exhaled NO, which is a biomarker for asthma. Monitoring NO levels allows doctors to more accurately tailor treatment strategies.
7. Transoral gastroplasty, or TOGA: a new experimental weight-loss option for obese patients who want to lose weight and improve their health without undergoing major surgery. This “scar-less” procedure represents a significant improvement in minimally-invasive bariatric surgery and losses approaching 40 percent of excess body weight can be expected within a year.
6. Telehealth monitoring for heart failure patients: Miniature implantable monitors to measure pulmonary artery pressure daily and at-home devices to monitor weight, heart rate and blood pressure of heart failure patients allow doctors to adjust medication quickly, improving patient outcomes and quality of life, while reducing re-hospitalizations.
5. Hepatitis C protease-inhibiting drugs: Two drugs awaiting FDA approval treat hepatitis C using protease inhibitors, which work by blocking a key enzyme that viruses need to copy themselves and proliferate. In clinical trials, cure rates for the protease inhibitors are higher than current hepatitis C treatments, with fewer side effects.
4. JUPITER study and statins for healthy individuals: The JUPITER (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin) trial pointed out for the first time that many seemingly healthy people are at higher risk for heart disease than previously thought, suggesting that statins should be prescribed even to people with low LDL (bad cholesterol), if they have high C-reactive protein levels.
3. First therapeutic cancer vaccine approved by the FDA: While not a cure for prostate cancer, sipuleucel-T is the first cancer vaccine to receive FDA approval. Prescribed to men with advanced prostate cancer, the drug coaxes their own immune systems to attack and remove the cancer, reducing the risk of death by 24 percent compared to placebo.
2. Anti-CTLA-4 drug (ipilimumab), a targeted T-cell antibody for metastatic melanoma: The effectiveness of ipilimumab in treating melanoma confirms the role of immunotherapy as an effective treatment. In patients with advanced stage III or IV melanoma, 23 percent were still alive after two years compared to 14 percent of patients who received standard treatment.