Abstract
Background: Multicomponent non-pharmacological therapies have been shown to be effective at reducing cognitive symptoms and slowing deterioration in abilities to perform activities of daily living (ADL) in individuals with cognitive impairment. However, little is known about response rates and predictors of response. Methods: We used data from the German day-care study (DeTaMAKS; De = dementia, Ta = Tagespflege/day-care, M = motor stimulation, A = activities of daily living stimulation, K = k/cognitive stimulation, S = social stimulation; n = 362), which was based on a cluster-randomized trial of the non-pharmacological, multicomponent, anti-dementia MAKS therapy for people with cognitive impairment in day-care centers. We investigated response (defined as improvement or no deterioration) for three different response criteria: cognition via Mini-Mental State Examination (MMSE) score, ADL via Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM) score, and behavioral and psychological symptoms of dementia (BPSD) via Neuropsychiatric Inventory Questionnaire (NPI-Q) score. In addition, we calculated the number needed to treat (NTT) and response rates according to net gain analyses. Results: For all three criteria, the response rates were higher in the intervention group than in the control group (chi2 test: p = 0.058 to p = 0.003). Compared with non-responders, responders according to cognition had higher ETAM scores (= better ADL abilities) at baseline; responders according to ADL had lower ETAM scores (= poorer ADL abilities) at baseline; and responders according to BPSD had higher NPI-Q scores (= more BPSD) at baseline. Classification rates based on these predictors ranged from 60.6 to 68.3%. Discussion: The response rates to the non-pharmacological MAKS therapy were greater than those reported for anti-dementia drugs. There were only a few differences between responders and non-responders. Because of the low classification rates, these variables had only a small impact on response predictions. Therefore, there are no empirically substantiated selection criteria for the application of MAKS therapy in facilities. Clinical Trial Registration: www.ClinicalTrials.gov, identifier ISRCTN16412551.
Highlights
According to the World Health Organization (WHO) [1], the total number of individuals with dementia worldwide is estimated at 50 million and may triple within the 30 years
Participants achieved a mean Mini-Mental State Examination (MMSE) value of 19.6 (SD = 4.8) with cognitive impairment ranging from mild cognitive impairment to mild and moderate dementia
There were no significant differences between the Intervention group (IG) and Control group (CG) on the baseline data except the central nervous system (CNS) depressant score (CG-person with dementia (PWD) had a higher CNS depressant score than IG-PWDs) and the variable reflecting whether the caregiver lived in the same house with the PWD (CG-PWDs were more likely to live in the same house with their caregiver)
Summary
According to the World Health Organization (WHO) [1], the total number of individuals with dementia worldwide is estimated at 50 million and may triple within the 30 years. In cholinesterase inhibitor (CEI) trials, intervention groups (IGs) have shown around 14 to 37% more responders on cognitive outcomes than placebo groups, depending on the drug, severity of dementia, and response criterion [4]. A recent cohort analysis called into question the long-term effects by showing that initial improvement on the Mini-Mental State Examination (MMSE) seemed to vanish after about 1 year of treatment [5]. Treatment with CEIs was associated with adverse effects such as bradycardia or syncope [6]. In a recent responder analysis for patients with mild to moderate Alzheimer’s disease treated with Donepezil, differences in the response rates of the IG versus the placebo group of 12 to 16% were found on cognitive outcomes [7]. Little is known about response rates and predictors of response
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