Yes / There are no disease-modifying treatments for dementia. There is also no consensus on
disease modifying outcomes. We aimed to produce the first evidence-based consensus on
core outcome measures for trials of disease modification in mild-to-moderate dementia.
We defined disease-modification interventions as those aiming to change the underlying
pathology. We systematically searched electronic databases and previous systematic
reviews for published and ongoing trials of disease-modifying treatments in mild-to-moderate
dementia. We included 149/22,918 of the references found; with 81 outcome measures
from 125 trials. Trials involved participants with Alzheimer's disease (AD) alone (n = 111), or
AD and mild cognitive impairment (n = 8) and three vascular dementia. We divided outcomes
by the domain measured (cognition, activities of daily living, biological markers, neuropsychiatric
symptoms, quality of life, global). We calculated the number of trials and of
participants using each outcome. We detailed psychometric properties of each outcome.
We sought the views of people living with dementia and family carers in three cities through
Alzheimer's society focus groups. Attendees at a consensus conference (experts in dementia
research, disease-modification and harmonisation measures) decided on the core set of
outcomes using these results. Recommended core outcomes were cognition as the fundamental
deficit in dementia and to indicate disease modification, serial structural MRIs. Cognition
should be measured by Mini Mental State Examination or Alzheimer's Disease
Assessment Scale-Cognitive Subscale. MRIs would be optional for patients. We also made
recommendations for measuring important, but non-core domains which may not change
despite disease modification.
Most trials were about AD. Specific instruments may be superseded. We searched one
database for psychometric properties.
This is the first review to identify the 81 outcome measures the research community uses for
disease-modifying trials in mild-to-moderate dementia. Our recommendations will facilitate
designing, comparing and meta-analysing disease modification trials in mild-to-moderate
dementia, increasing their value. / National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Bart's Health NHS Trust
| Identifer | oai:union.ndltd.org:BRADFORD/oai:bradscholars.brad.ac.uk:10454/14462 |
| Date | 31 May 2017 |
| Creators | Webster, L., Groskreutz, D., Grinbergs-Saull, A., Howard, R., O'Brien, J.T., Mountain, Gail, Banerjee, S., Woods, B., Perneczky, R., Lafortune, L., Roberts, C., McCleery, J., Pickett, J., Bunn, F., Challis, D., Charlesworth, G., Featherstone, K., Fox, C., Goodman, C., Jones, R., Lamb, S., Moniz-Cook, E., Schneider, J., Shepperd, S., Surr, Claire A., Thompson-Coon, J., Ballard, C., Brayne, C., Burns, A., Clare, L., Garrard, P., Kehoe, P., Passmore, P., Holmes, C., Maidment, I., Robinson, L., Livingston, G. |
| Source Sets | Bradford Scholars |
| Language | English |
| Detected Language | English |
| Type | Article, Published version |
| Rights | © 2017 The Authors. This is an Open Access article distributed under the Creative Commons CC-BY license (http://creativecommons.org/licenses/by/4.0/) |
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