In a phase 2 clinical trial, Aricept (donepezil) improved scores on cognitive tests and reports of global functioning in patients with dementia with Lewy bodies (DLB). Phase 3 trials are still needed before Aricept will be approved for this use.
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DLB is a type of dementia where Lewy bodies build up in the brain and interfere with brain cell function. It is similar to Alzheimer’s disease in some ways, but is marked by a different set of substances that build up in the brain.
The phase 2 trial using Aricept to treat DLB was headed by Etsuro Mori, MD, PhD, of the Department of Behavioral Neurology and Cognitive Neuroscience, Tohoku University Graduate School of Medicine, in Sendai, Japan.
There were 140 patients in the study who received either 3, 5 or 10 mg/day doses of Aricept or a placebo pill for 12 weeks. Patients underwent cognitive tests and interviews to assess global function.
Their caregivers were also asked to report on global function and caregiver burden.
The study found that, at the end of 12 weeks, all doses improved global functioning scores. The 5 and 10 mg/day doses improved scores on cognitive tests, and the highest dose, 10 mg/day, led to lower scores on measures of caregiver burden.
They reported that Aricept was well tolerated by the patients in the study.
Both DLB and Alzheimer’s disease are associated with lower activity of the neurotransmitter acetylcholine in the brain.
Aricept is an acetylecholinesterase inhibitor. Acetylcholinesterase is an enzyme that cleans up unneeded acetylcholine. By blocking or inhibiting this enzyme, the drug increases the amount of acetylcholine available for use by the brain.
These phase 2 results are just one step toward gaining approval for the use of Aricept to treat DLB. Larger phase 3 trials must still be done to further investigate the safety and effectiveness of the drug for this type of dementia.
This study was published in July in the Annals of Neurology.