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ii Interventions in Alzheimer’s Disease KCE reports 111C RESULTS THE DIAGNOSTIC PROCESS Targeted screening Diagnosis At present, no single diagnostic instrument is good enough for use as a tool for population screening. Many methods (scales and indices) are used to measure the severity of various symptoms of dementia, such as cognitive deterioration, functional decline and behavioural changes. The insufficient evaluation of most screening and diagnostic methods makes it even more difficult to assess the efficacy of specific care and treatment approaches. Also the lack of biomarkers which reliably predict progression reduces the ability to assess response to treatment. An initial selection or screening of patients for possible further diagnosis can be made by general practitioners and can be based on standardised interviews with collateral sources, such as informal or family caregivers, as well as on simple tests such as the MMSE, the clock drawing test and other simple tests. Such initial selection by general practitioners is to be distinguished from a diagnostic work-up. Neuropsychological testing has been recommended following the baseline assessment in all patients but is particularly useful in patients with MCI and mild AD. The reference standards for the diagnosis of AD are given in the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV-TR) and by the National Institute of Neurological and Communicative Disorders and Stroke – the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) working group. Based on an analysis of all available evidence, a revision of these latter criteria for clinical diagnosis has been proposed in 2007. The revised criteria reflect the increasing importance of new markers, in addition to the core diagnostic criterion of early episodic memory impairment (episodic memory is memory for events that the patient experienced and should be able to recall, more specifically for recent events). These new supportive features are now being used in clinical trials and in expert centres. They require further standardisation and demonstration of incremental diagnostic benefit over and above that of episodic memory impairment benefit before they can enter routine care. These four supportive tests are 1. the presence of medial temporal lobe atrophy on magnetic resonance imaging (MRI), 2. abnormal cerebrospinal fluid (CSF) biomarker values (amyloid beta1-42, total tau, and phospho-tau), 3. a specific pattern on functional neuroimaging with 18F-FDG positron-emission tomography (PET), or 4. a proven AD autosomal dominant mutation within the immediate family. Other promising tests such as the visualisation of amyloid plaques using specific PET exams are still in the early research phase. Health-economic studies that have combined different types of testing are lacking. As a consequence, it is not known with certainty which approaches are most cost-effective.
KCE reports 111C Interventions in Alzheimer’s Disease iii NON-PHARMACOLOGICAL INTERVENTIONS Many methodological difficulties were encountered when non-pharmacological interventions were reviewed. Most of the studies have a small sample size. Compared with pharmacological treatments there is a relative lack of large randomized controlled trials (RCTs). The patient study population are often ‘dementia’ patients without a welldocumented clinical diagnosis, a reason for study exclusion for some authors of systematic reviews. Often there is also no involvement of physicians in the studies. In addition, there is often a lack of standardization of the specific non-pharmacological interventions and validation of the scales used as study endpoint. As a result different authors tend to group studies differently. We grouped interventions into four categories. 1. Patient interventions, analysis by type of intervention A first group of reviews focused on specific interventions and their effects on the patient. These interventions target patient cognition (reality orientation, cognitive stimulation, training or rehabilitation), patient emotion (reminiscence therapy, validation therapy, self-maintenance therapy, individualized special instruction), sensory stimulation (“snoezelen” or multisensory stimulation, massage and touch, aromatherapy, simulated presence therapy, music therapy), structured or physical activities, ADL rehabilitative care, interventions targeting communication or interventions on the patient environment (bright light, broad intensive care programs in dementia units, redirect attention away from the exit). We could not find any high quality evidence to support or reject these interventions. Sometimes a single study was positive, but in this field of research repeating a study using the same intervention and the same endpoint is exceptional. When studied, effects were often transient. For some interventions two or more RCTs reported positive outcomes. However, intervention modalities and outcome measures differed between these trials. Such interventions are considered promising and include cognitive stimulation (alone or add-on to therapy with inhibitors of acetylcholinesterase), ADLrehabilitative care, music therapy, massage/touch, and physical activity. 2. Patient interventions, analysed for effect on patient behaviour and wandering A second group of reviews focused on specific patient signs and symptoms, and especially on the effect of interventions on patient behaviour and wandering. Again, high quality evidence is lacking. 3. Technological support interventions Thirdly, a single review discussed technological support interventions (eg communication tools). These have mainly been developed for younger persons with physical disabilities. No good quality studies on the use of such tools for dementia patients are available. 4. Interventions targeting caregivers Last but not least, one of the promising area’s of dementia research concerns the interventions to prevent the negative consequences of caring for a person with dementia. Care at home for as long as possible is often preferred over institutionalisation both by the patient and the family-caregiver. Caring for a person with dementia at home is however intensive and burdensome. Caregivers are at high risk of psychosocial morbidity and associated breakdown in care. Some moderate level evidence was found for a positive effect of several forms of psychosocial interventions and psychoeducation on informal caregiver depression and stress. However, reviews draw different conclusions on the benefit of individual sessions versus group based sessions. Education and training of staff were found to be promising interventions. Because of conflicting conclusions between systematic reviews, SBU concluded that there was no evidence of benefit for caregivers from respite care, nor for placing the elderly relative in a nursing home or special care unit.
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KCE reports 33 Effects and costs of
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