Experimental Dimebon Improves Cognition and Behaviour in Patients With Mild and Moderate Alzheimer's Disease: Presented at ICAD

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Title: Experimental Dimebon Improves Cognition and Behaviour in Patients With Mild and Moderate Alzheimer's Disease: Presented at ICAD
URL: http://www.pslgroup.com/dg/226B6A.htm
Doctor's Guide
July 31, 2008

By Ed Susman

CHICAGO -- July 31, 2008 -- After 1 year of treatment with the experimental neuron mitochondrial protective agent dimebon, patients with mild to moderate Alzheimer's disease showed either no decline or an improvement in measures of cognition, memory, activities of daily living, behaviour, and global functions, researchers reported here at the 2008 International Conference on Alzheimer's Disease (ICAD).

In the study, patients with moderate Alzheimer's disease treated with dimebon had an improvement of 9.7 points compared with placebo on the Alzheimer's Disease Assessment Scale (ADAS-cog), according to researcher Rachelle Doody, MD, Baylor College of Medicine, Houston, Texas.

In their study, presented as a poster on July 30, Dr. Doody and colleagues scrutinised results by separating patients with mild Alzheimer's disease and with moderate Alzheimer's disease and reviewed how each group performed in measures of efficacy.

While the study was a phase 2 trial, it was designed as a phase 3, placebo-controlled study, Dr. Doody said.

Dimebon was previously used in the Soviet Union as a mild antihistamine, but Dr. Doody said its effect in patients with Alzheimer's disease is independent of its antihistaminic properties; therefore, treatment with other antihistamines in Alzheimer's disease is unlikely to have any effectiveness.

The researchers recruited 94 patients diagnosed with mild Alzheimer's disease. They assigned 45 patients to dimebon 20 mg 3 times daily. Also recruited were 89 patients who met the criteria for moderate Alzheimer's disease; 44 of them were also randomly assigned to receive dimebon. The others were given placebo tablets.

Results showed a 5.4-point difference in ADAS-cog scores after 1 year of treatment among patients with mild Alzheimer's disease when compared with placebo (P = .0027) and a 9.7-point difference among patients with moderate Alzheimer's disease compared with placebo (P < .0001).

After 1 year, there was a 3.1-point nonsignificant difference in Activities of Daily Living scores among the patients with mild Alzheimer's disease when compared with placebo (P = .1879) and a 9.1-point difference among those with moderate disease compared with placebo (P = .0005).

A 1.5-point nonsignificant difference in Neuropsychiatric Inventory scores was seen for mild Alzheimer's disease patients compared with placebo after 1 year (P = .5281). The difference was 6.8 points for patients with moderate Alzheimer's disease compared with placebo (P = .0073).

Dimebon was safe and well tolerated.

Dr. Doody concluded, "Dimebon improves the clinical course of patients with both mild and with moderate Alzheimer's disease."

Funding for this study was provided by Medivation Inc. The company was informed by the US Food and Drug Administration that the trial can be included as 1 of 2 pivotal trials required for approval.

The study results were also published in The Lancet (Doody RS et al. 2008;372:207-215).

[Presentation title: Dimebon Improves Cognition, Function, and Behavior in Mild and Moderate Alzheimer's Disease: Results by Severity of a One-Year, Double-Blind, Placebo-Controlled Study. Abstract P4-337]

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