Objective: To understand the characteristics of a population of patients enrolled in a long-term, open-label study of probable vascular dementia (VaD) or Alzheimer's disease with cerebrovascular disease (AD + CVD).
Background: AD and VaD are the 2 most common forms of dementia, and there is considerable overlap between these conditions in terms of clinical signs and symptoms. Although it is tempting classify AD and VaD as distinct clinical entities, evidence suggests that "pure AD" and "pure VaD" may represent the extremes of a continuum of dementia, with "mixed dementia" (AD + CVD) occurring in a large proportion of patients. AD and VaD have common pathologic mechanisms (eg, white matter lesions and micro-infarcts) and associated risk factors (eg, vascular and genetic). For instance, impairment in cholinergic function is thought to underlie cognitive decline in both dementia types.
Design/Methods: Patients enrolled in this study met the following inclusion criteria: 1) probable VaD according to the NINDS-AIREN criteria or possible AD according to the NINCDS-ADRDA criteria with significant radiologic evidence of CVD on computed tomography or magnetic resonance imaging; 2) mild-to-moderate dementia (10 to 25 on the MMSE or ³ 12 on the ADAS-cog); and 3) disease onset between the ages of 40 and 90 years. Eligible patients were randomized to placebo or galantamine 24 mg/day for 6 months, followed by a 6-month, open-label extension phase in which all patients received galantamine 24 mg/day. Upon completion of this phase, patients could enter a further 24-month, open-label extension trial with a fixed daily dose of galantamine 24 mg/day. Differential patient demographics are described for patients entering the 24-month, open-label extension phase.
Results: 326 patients entered the 24-month, open-label extension phase; 221 patients had received galantamine continuously throughout the study. 181 (55.5%) patients were male and the majority of patients were of Caucasian origin (99.7%). The mean age (SD) of all patients was 76.4 (7.19). Mean (SD) MMSE score was 20.8 (3.46). AD + CVD was diagnosed in 53.1% of patients and probable VaD was diagnosed in 41.4% of patients; 5.5% had a dementia diagnosis of unknown etiology, which included CVD.
Conclusions: Patients in this study have a distinct form of dementia characterized as either AD + CVD or VaD. These patients differ from those in AD clinical trials and thus represent a separate population in which the long-term use of galantamine has been shown to be safe and effective.
Back to PB Tuesday Poster Sessions
Back to The Eleventh International Congress