O5‐07‐04: Dependence Levels as Interim Clinical Milestones Along the Continuum of Alzheimer’s Disease (AD): 18‐Month Results from the Geras Observational Study

The gradual, progressive nature of AD can make it difficult to identify clinically relevant milestones. Functional dependence, the level of assistance patients require consequent to AD deficits, may be useful to identify milestones of AD progression. Previous cross-sectional analysis of GERAS study baseline data from AD dementia patients found a significant relationship between functional dependence stages and cognitive severity (Kahle-Wrobleski JPAD 2015;2:115-20). Current aims are to describe patterns of change in dependence over 18 months in groups stratified according to cognitive AD severity and to identify characteristics associated with patients showing worsening dependence (“progressors”). Longitudinal data from GERAS, a prospective, naturalistic, observational cohort study conducted in France, Germany, and the UK, were analyzed (Wimo JAD 2013;36:385-99). Of 1495 community-living participants (aged ≥55 years, diagnosed with probable AD [Mini-Mental State Examination (MMSE) score ≤26]) and their caregivers, 971 patients had both baseline and 18-month AD Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) data. Patients were assigned to one of six derived dependence levels, based on ADCS-ADL responding patterns (Table 1). Patients were stratified according to AD dementia severity by baseline MMSE scores. Baseline factors associated with progression/non-progression of dependence level were identified using stepwise logistic regression analysis. Figure 1 and 2 show dependence level distributions for the entire cohort and according to baseline AD dementia severity, respectively, at baseline and 18 months; overall, 58% (563/971) of patients showed improvement/no change in dependence levels over 18 months while 42% (408/971) worsened. Similar proportions of progressors/non-progressors were observed at all levels of AD dementia severity. Baseline factors predictive of increasing dependence included: more severe cognitive impairment, living alone, multiple caregivers, and elevated caregiver burden. About 40% of patients with probable AD became more dependent over 18 months. Dependence levels may be considered as meaningful interim clinical milestones that reflect AD-related functional deficits, although a time frame longer than 18 months may be necessary to observe changes if used for clinical trials or other longitudinal research. Dependence Levels distribution of entire cohort at baseline and 18 months. Patients with AD (as determined by baseline MMSE cognitive scale) were assigned to one of six derived dependence levels, based on functional ability using the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL), at baseline and 18 months. Lower levels of dependence indicate better function. Compared with baseline, at 18 months fewer AD dementia patients in the overall patient sample fell within the Level 2 category and, correspondingly, more patients were found to require care equivalent to that provided by assisted living plus nursing support or placement into a nursing home (Levels 4 and 5). A small proportion of patients at both time points showed either no functional impairment (Level 0) or slight impairment (Level 1). Dependence level distributions according to AD dementia severity at a) baseline and b) 18 months. Patients were stratified according to disease severity by baseline cognitive function using the MMSE as having mild (26-21), moderate (20-15) or moderately severe/severe (≤14) AD dementia. Patients with AD dementia were then assigned to one of six derived dependence levels, based on functional ability assessed using the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL). Lower levels of dependence indicate better function. At both baseline and after 18 months, patients with AD dementia at all levels of severity show variability in levels of dependence. At baseline, there appears to be a direct association between level of AD dementia severity and dependence. For example, patients in the mild AD dementia group had more patients with low levels of dependence, and fewer patients with higher levels of dependence, than patients in the moderate or moderately severe AD dementia groups. From baseline to 18 months, increasing proportions of patients were more dependent in all AD dementia severity groups. For example, about almost 50% of those diagnosed with mild AD dementia at baseline required the equivalent of limited or informal home care services (dependence Level 2), whereas 44% required at least the equivalent of extensive home care services with supervision or assisted living (Levels 3, 4 and 5). After 18 months, fewer patients with mild AD dementia showed the equivalent of Level 2 dependence (31%). Instead, a greater proportion (65%) of patients initially diagnosed with mild AD dementia required higher levels of assistance (Levels 3, 4, and 5). In those with moderate AD dementia, after 18 months a rise from baseline was seen in the proportion of patients requiring the equivalent of assisted living plus nursing support or placement in a nursing home. No patients lived independently at this stage of disease. Most of those with moderately severe or severe AD dementia needed high levels of assistance at 18 months.

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