Pfizer and biopharmaceutical company Medivation have initiated a 12-month, Phase III clinical trial of the investigational drug Dimebon.
The study, known as Concert, will evaluate the safety and efficacy of Dimebon when added to ongoing treatment with donepezil HCI tablets, for patients with mild-to-moderate Alzheimer’s disease.
Karolinska Institute professor of geriatrics Bengt Winblad said that this trial may serve to demonstrate the potential of Dimebon in Alzheimer’s disease.
“The Concert trial will explore the potential additive effects of Dimebon to ongoing donepezil therapy, two drugs thought to have different mechanisms of action,” said Winblad.
The study builds on data from a small-scale safety and tolerability trial of Dimebon added to donepezil, which found the combination to be well tolerated. Concert is designed to complement previous and ongoing studies by further evaluating the efficacy of Dimebon.
The Phase III programme also includes the confirmatory six-month Connection study, which is designed to evaluate the safety and efficacy of Dimebon monotherapy in patients with mild-to-moderate Alzheimer’s disease and builds on results of the first pivotal trial of Dimebon in Alzheimer’s disease.
Dimebon is an investigational compound currently in Phase III development for the treatment of Alzheimer’s disease and in clinical development for Huntington’s disease.