New Data Shows Cognitive Impairment Precedes and Predicts Subsequent Functional Impairment in Patients with Mild Alzheimer's Disease
"These data support the concept that decline in cognition is later reflected in changes in function. This suggests that with treatments that target the underlying neuropathology of disease, effects on function may take longer to observe in clinical studies," said
The objective of the study was to better understand the relationship between cognitive and functional decline in mild Alzheimer's disease by using pooled data from placebo patients from the solanezumab EXPEDITION and EXPEDITION2 trials and the semagacestat IDENTITY and IDENTITY2 trials, as well as data from the Alzheimer's Disease Neuroimaging Initiative study (ADNI), which is an observational study.
The results from the analyses of the placebo data from the EXPEDITION and EXPEDITION2 trials demonstrated that cognitive impairment significantly predicted future functional impairment in five out of six time points. When the same analysis method was used to test the opposite hypothesis, results showed that functional scores predicted cognitive outcomes in only one out of six time points. The data from the IDENTITY and IDENTITY2 trials were more limited due to early termination of the trials and a smaller sample size, but the analyses still yielded consistent results that cognitive impairment predicted subsequent functional impairment. Analyses based on the mild patients from the ADNI study had similar limitations of small sample size but again replicated the findings that cognitive impairment predicted future functional impairment. These similar findings were observed even though the ADNI study used a different functional measure, the Functional Activities Questionnaire (FAQ).
Data from placebo patients with mild Alzheimer's disease (Mini-Mental State Examination score 20 to 26) were pooled from the Phase 3 solanezumab studies, EXPEDITION and EXPEDITION2, and separately for the two semagacestat studies, IDENTITY and IDENTITY2. Cognitive and functional outcome measures were assessed at baseline and six post-baseline time points every three months for 18 months using the Alzheimer's disease Assessment Scale-Cognitive subscale (ADAS-Cog14) and the Alzheimer's disease Cooperative Study-Activities of
About Alzheimer's Disease
Alzheimer's disease is a fatal illness that causes progressive decline in memory and other aspects of cognition.2 It is the most common form of dementia, accounting for 60 to 80 percent of dementia cases.2 There are currently an estimated 44 million people living with dementia worldwide.3 The number of people affected by dementia is expected to be more than 75 million in 2030 and 135 million in 2050.3
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1 Zahodne LB, Manly JJ, MacKay-Brandt A, Stern Y. Cognitive Declines Precede and Predict Functional Declines in Aging and Alzheimer's Disease. PLoS ONE. 2013; 8(9).
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