JAMA Logo Patients diagnosed with Alzheimer’s disease consuming diabetes medications may stir an air of worry. The following article highlights the safety of diabetes drug for individuals with Alzheimer’s. A recent study suggests that diabetes medication pioglitazone is harmless for patients with Alzheimer’s disease.

It is claimed that the nuclear receptor peroxisome proliferator-activated receptor gamma, PPAR-gamma is another potential target for treating Alzheimer’s disease. This receptor is known to control glucose and lipid metabolism. In patients with type 2 diabetes, a class of drugs termed as thiazolidinediones may be recommended for decreasing insulin resistance. Experts regard thiazolidinediones as potent agonists that trigger a response of PPAR-gamma.

Experts elucidate, “Alzheimer’s disease is an immense and growing public health problem. Prescription drug therapy for the symptoms of Alzheimer’s disease has been available since 1993, these agents do not fundamentally alter the pathological expression of the disease or its progressive course. The failure of several recent treatment trials directed at the beta-amyloid peptide, a key pathological correlate of Alzheimer’s disease, suggests a need to explore alternative approaches to Alzheimer’s disease treatments that are not focused on beta-amyloid metabolism.”

Investigators aimed to analyze the safety of pioglitazone, which is one of these medications, in patients without diabetes but with Alzheimer’s disease. David S. Geldmacher, M.D., of the University of Virginia Health System, Charlottesville, and colleagues commenced an 18-month, double-blind, placebo-controlled randomized controlled trial. The study included twenty-nine patients free from diabetes but with probable Alzheimer’s disease. There were randomly selected to receive pioglitazone (titrated to 45 milligrams daily) or matching placebo, plus 200 international units of vitamin E.

From the study participants, 25 patients accomplished 18 months of therapy. From these volunteers, while 12 were given pioglitazone, 13 were provided with placebo. It was mentioned that two patients who discontinued participation in the study early had a change in caregivers status and the other two withdrew their consent. Experts note that none of the discontinuations took place due to the occurrence of any adverse events.

Scientists highlight, “Disappointing results of treatment trials based on the amyloid hypothesis, and the reasonable degree of safety identified in this trial, suggest that exploratory studies of thiazolidinediones remain warranted. Future studies of this class should focus on earlier stages of disease progression and be augmented by biomarkers, such as nuclear imaging techniques, to measure changes in microglial activation associated with treatment.”

Four patients from the pioglitazone group forming 28.6 percent, reported peripheral edema, swelling of the legs and feet. None of these events were suffered by the placebo group. The authors were unable to register group variations in laboratory measures. Also considerable treatment effects were seemingly not monitored on exploratory analysis of clinical efficacy. It has been suggested that the study has to encompass 155 and 340 participants randomly assigned to placebo or pioglitazone to find treatment effects for patients with Alzheimer’s disease. Further studies will be initiated to assess the clinical efficacy of pioglitazone.

The study is published online and will appear in the January 2011 print issue of Archives of Neurology, one of the JAMA/Archives journals.