Study Outcome Measures: The effectiveness of treatment with ARICEPT® was determined using a dual outcome assessment strategy that evaluated cognitive function using an instrument designed for more impaired patients and overall function through caregiver-rated assessment. This study showed that patients on ARICEPT® experienced significant improvement on both measures compared to placebo.

The ability of ARICEPT® to improve cognitive performance was assessed with the Severe Impairment Battery (SIB). The SIB, a multi-item instrument, has been validated for the evaluation of cognitive function in patients with moderate to severe dementia. The SIB evaluates selective aspects of cognitive performance, including elements of memory, language, orientation, attention, praxis, visuospatial ability, construction, and social interaction. The SIB scoring range is from 0 to 100, with lower scores indicating greater cognitive impairment.

Daily function was assessed using the Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-severe). The ADCS-ADL-severe is derived from the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory, which is a comprehensive battery of ADL questions used to measure the functional capabilities of patients. Each ADL item is rated from the highest level of independent performance to complete loss. The ADCS-ADL-severe is a subset of 19 items, including ratings of the patient's ability to eat, dress, bathe, use the telephone, get around (or travel), and perform other activities of daily living; it has been validated for the assessment of patients with moderate to severe dementia. The ADCS-ADL-severe has a scoring range of 0 to 54 with the lower scores indicating greater functional impairment. The investigator performs the inventory by interviewing a caregiver, in this study a nurse staff member, familiar with the functioning of the patient.

Effects on the SIB

Figure 7 shows the time course for the change from baseline in SIB score for the two treatment groups over the 24 weeks of the study. At 24 weeks of treatment, the mean difference in the SIB change scores for ARICEPTR -treated patients compared to patients on placebo was 5.9 units. ARICEPT treatment was statistically significantly superior to placebo.

Figure 7. Time Course of the change from baseline in SIB score for Patients completing 24 weeks of treatment.

Figure 8 illustrates the cumulative percentages of patients from each of the two treatment groups who attained the measure of improvement in SIB score shown on the X-axis. While patients assigned both to ARICEPT® and to placebo have a wide range of responses, the curves show that the ARICEPT® group is more likely to show a greater improvement in cognitive performance.

Figure 8. Cumulative percentage of patients completing 24 weeks of double-blind tratment with particular changes from baseline in SIB scores.

Figure 9. Time course of the change from baseline in ADCS-Adl-severe score for patients completing 24 weeks of treatment.

Effects on the ADCS-ADL-severe: Figure 9 illustrates the time course for the change from baseline in ADCS-ADL-severe scores for patients in the two treatment groups over the 24 weeks of the study. After 24 weeks of treatment, the mean difference in the ADCS-ADL-severe change scores for ARICEPT® treated patients compared to patients on placebo was 1.8 units. ARICEPT treatment was statistically significantly superior to placebo.

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