Objective: The objective of these analyses was to examine population characteristics and pattern of cognitive decline in probable vascular dementia (VaD) patients selected using the NINDS-AIREN criteria.
Background: Due to a lack of awareness of its characteristic clinical features and risk factors, VaD may be under-recognized and therefore undertreated. There is some degree of overlap in the pathology of Alzheimer’s disease (AD) and VaD, however clinical features and neuroimaging results can be used to distinguish the two diseases. NINDS-AIREN criteria are a specific and reproducible method for the identification of VaD and the differentiation of VaD from AD.
Design: Combined analyses of two double-blind, randomized, placebo-controlled, 24-week studies of donepezil (5 or 10 mg/day) in patients with probable or possible VaD.
Materials and Methods: All enrolled patients had a diagnosis of VaD of >3 months’ duration according to NINDS-AIREN criteria (ie, evidence of dementia and a probable relationship between dementia and cerebrovascular disease). Patients with a prior diagnosis of AD and subsequent cognitive impairment due to stroke or other cerebrovascular disease were excluded. Patient characteristics were assessed and recorded at screening (3 weeks prior to baseline). Doses (placebo, and 5 or 10 mg/day donepezil) were administered once daily. Assessments were performed at Weeks 6, 12, 18, and 24. Efficacy measures included ADAS-cog and CIBIC-plus. Screening data are reported for the probable VaD patients, efficacy data are reported only for placebo-treated probable VaD patients (Week 24 observed cases).
Results: 1219 patients were enrolled; 73% (893) had a diagnosis of probable VaD (the remainder had possible VaD). At screening, probable VaD patients had a mean Hachinski score of 10.3. Prior to onset of dementia, 73% of patients had a history of at least one stroke, and 19% had a history of transient ischemic attack. 82% of patients had experienced an abrupt onset of cognitive symptoms. Nearly 90% of patients had a history of cardiovascular disease. Vascular risk factors were prominent and included: history of hypertension (72%), smoking (62%), and hypercholesterolemia (41%). All of the enrolled patients had abnormal CT or MRI scans. The majority of patients were administered concomitant medications, with cardiovascular condition treatments being common. During the study, placebo-treated patients (n=283) maintained cognitive function (ADAS-cog least-squares mean change from baseline score: -0.23; n=228), and exhibited stable global function (CIBIC-plus ratings were centered on ‘no change’, with 44% in this category [n=104]).
Conclusion: The NINDS-AIREN criteria were central to selecting this VaD population, which differed from those enrolled in AD trials. The patients enrolled in these trials with probable VaD had a broad range of cardiovascular disease. Placebo-treated patients with probable VaD, in contrast to placebo-treated patients with AD, demonstrated stable cognitive function over 24 weeks.
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