Effect of Social Restriction Due to the COVID-19 Pandemic on Activity of Daily Living and Disease Severity of Patients With Alzheimer Disease: Sub-analysis of a Double-blinded Noninferiority Study of Donepezil Patches and Donepezil Tablets.

Background: We previously reported that social restrictions due to the COVID-19 pandemic led to a decline in cognitive function in patients with Alzheimer disease (AD). Here, we assessed the effects of COVID-19 restrictions on the activities of daily living (ADL) and disease severity in patients by comparing them to a control group.

Methods: We examined the impact on ADL, evaluated using disability assessment for dementia (DAD), and disease severity, evaluated using the ABC dementia scale, in patients with mild-to-moderate AD. We conducted a post hoc subgroup analysis of a double-blinded, noninferiority study of donepezil 27.5 mg patches and donepezil hydrochloride 5 mg tablets (JapicCTI-194582). After showing the noninferiority of both treatments, we combined the data from both groups for analysis.

Results: The subpopulation of the per-protocol set grouped by completing the double-blinded evaluation before and on/after the mild lockdown was balanced (n=136 and n=120). Patient demographics were similar between the subgroups. The decline in the DAD and ABC dementia scale scores [least-squares mean (SE)] was ameliorated by social restriction [-3.810 (0.743) and -1.871 (0.697) and -1.147 (0.285) and -0.419 (0.267), respectively (not significant)].

Conclusion: Normalcy and expectation biases can affect the evaluation of ADL and disease severity by caregivers under high stress and deterioration of mental conditions.