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Vascular Dementia Patients Benefit From Donepezil Treatment: Presented at APA

By Paula Moyer

SAN FRANCISCO, CA -- May 26, 2003 -- People with vascular dementia appear to benefit from a cholinesterase inhibitor such as donepezil (Aricept) in much the same way that people with Alzheimer's disease do, according to findings presented here May 22^nd at the 2003 Annual Meeting of the American Psychiatric Association.

However, say researchers, treatment for vascular dementia seems to be associated with improvement rather than with a slowing of the disease's progression.

Stephen P. Salloway, MD, and colleagues presented the results of the trials. Dr. Salloway, director of the Memory Disorders Program at Butler Hospital and an associate professor of clinical neuroscience at Brown Medical Center in Providence, Rhode Island, United States, attributed this treatment effect to the difference in the natural course in the 2 dementia subtypes and noted that vascular dementia is characterized by long periods of stabilization.

"These are the first large-scale placebo-controlled trials of an acetylcholinesterase inhibitor that have focused on people with possible or probable vascular dementia," he said.

Because there are currently no approved treatments for the cognitive symptoms of vascular dementia, and because prior research had suggested that such patients may benefit from treatment with cholinesterase inhibitors such as donepezil, the investigators conducted a combined analysis of 2 randomized, 24-week clinical trials of donepezil in 1,219 patients with probable or possible vascular dementia.

The criteria used to determine probable or possible vascular dementia were those that had been jointly established by the National Institute for Neurologic Disease and Stroke (NINDS) and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences (AIREN). They are therefore known as the NINDS-AIREN criteria

Patients received donepezil 5 mg/day (406 patients), donepezil 10 mg/day (421 patients), or placebo (392 patients). The 10-mg group received 5 mg daily for the first 28 days and 10 mg daily for the rest of the study period.

Both treated groups showed significant improvements in cognitive function compared with the placebo group, as measured by the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog). By week 24, the placebo group had a mean score change of -0,10, compared with a mean change of -1.89 in the 5-mg group and -2.38 in the 10-mg group (P<0.001 for each).

The investigators also documented significant benefits to treatment over placebo in global function. By week 24, 29% of the placebo patients had improved scores on the Clinician's Interview-Based Impression of Change, compared with 41% of the 5-mg group (P<0.001) and 33% of the 10-mg group (P=0.07)(P=0.001 overall). The treated patients also showed improvements on the Clinical Dementia Rating-Sum of the Boxes scores (CDR-SB).

By week 24, the placebo patients' mean CDR-SB score had increased by 0.10, while the 5-mg group's mean score had decreased by 0.11, and the 10-mg group's mean score had decreased by 0.33, (P=0.001 and P=0.002, respectively).

"One question one could ask is, 'Are we just treating an Alzheimer's disease population that has had cerebrovascular changes?'" Dr. Salloway said. "However, these patients differed in significant ways from typical Alzheimer's disease patients. Most were men, they were older than patients typically are in Alzheimer's disease trials, and they had higher Mini-Mental Status Exam scores. The imaging studies also showed more cerebrovascular disease than is typically seen in Alzheimer's disease."

These results show that donepezil may have potential for managing vascular dementia, he said.

The trials were sponsored by Eisai, Inc.


[Study title: Donepezil Provides Significant Benefits In Patients With Vascular Dementia. Abstract NR882]

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