Dimebon Clinical Trials
Dimebon clinical trials are currently being conducted in both the treatment of Alzheimer’s disease and the treatment of Huntington’s disease. Dimebon clinical trials are in phase III for Alzheimer’s and are phase II for Huntington’s disease.
Phase I clinical trials are the first phase of testing of a drug in humans. In most cases a small group of healthy volunteer subjects (20 – 80) are used in this phase of clinical trials. This phase includes trials designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug.
Phase II clinical trials are performed on larger groups of volunteers (20 – 300). This phase of clinical trials helps to determine the effectiveness of the drug as well as continues the assessment of the safety of the drug from Phase I.
Phase III clinical trials are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. While not always a requirement, it is common that there be at least two successful Phase III trials, demonstrating a drug's safety and efficacy, in order to obtain approval from the appropriate regulatory agencies such as the FDA (USA), TGA (Australia), EMEA (European Union), and Health Canada.
The phase III Dimebon clinical trial for Alzheimer’s treatment is as of October 20, 2008 in the recruiting phase according to ClinicalTrials.gov. The official title of the Dimebon clinical trial for Alzheimer’s is “A Global Phase 3, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease (CONNECTION)”.
This clinical trial study is a randomized, placebo-controlled 6-month study designed as an adequate and well-controlled trial to demonstrate the safety and efficacy of Dimebon in the treatment of patients with mild-to-moderate AD. Dimebon is an investigational drug for Alzheimer's disease. The target of Dimebon's mechanism of action are the mitochondria (a cell's primary source of energy). The Connection Study is the second of two pivotal studies evaluating the effect of Dimebon. It is a 6-month study enrolling 525 patients in the United States, Europe, and South America. All patients completing the 6-month study will be eligible to receive Dimebon in an open-label extension trial.
The primary outcome measures for this Dimebon clinical trial are to determine the effect of Dimebon as compared to placebo on the primary measure of cognition and memory, the ADAS-cog; and to determine the effect of Dimebon as compared to placebo on the primary measure of global function, the CIBIC-plus.
The secondary outcome measures for this Dimebon clinical trial are to determine the effect of Dimebon as compared to placebo on a measure of self care and daily function, the ADCS-ADL; • To determine the effect of Dimebon as compared to placebo on a measure of behavior, the NPI;
There are three arms to this Dimebon clinical trial. The first arm will receive Dimebon 5mg three times daily. The second arm will receive Dimebon 20mg three times daily. And the third arm of the clinical trial will receive placebo three times daily.
The previous Dimebon clinical trials in the treatment of Alzheimer’s have produced great results. We can only hope that this current clinical trial will further confirm the usefulness of Dimebon in the treatment of Alzheimer’s.