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Neurodegener Dis. 2014;13(2-3):197-9. doi: 10.1159/000353748. Epub 2013 Aug 7.

How can we improve transfer of outcomes from randomized clinical trials to clinical practice with disease-modifying drugs in Alzheimer's disease?

Author information

1
McGill Center for Studies in Aging, Douglas Mental Health Research Institute, Montreal, Que., Canada.

Abstract

BACKGROUND:

Randomized clinical trials (RCTs) for putative disease-modifying drugs in Alzheimer's disease (AD) are using cognitive outcomes, such as the Alzheimer's Disease Assessment Scale--cognitive subscale, activities of daily living scales, such as the Alzheimer's Disease Cooperative Study Activities of Daily Living, and time from mild cognitive impairment to AD dementia.

OBJECTIVE:

It was the aim of this study to build clinically relevant outcomes for future use in clinical practice into RCT designs and help third-party payers to measure benefit.

METHODS:

We used a literature review for analysis.

RESULTS:

The Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) appears to be the most reliable primary outcome for RCT at different stages of AD, with the Relevant Outcome Scale for Alzheimer's Disease (ROSA) as a suitable alternative. The importance of current AD biomarkers vis-à- vis determination of efficacy of disease-modifying drugs has yet to be established; however, it is likely that at least one amyloid-specific test will be required prior to treatment with a drug acting predominantly on β-amyloid (Aβ42). Furthermore, serial MRI may be required to monitor adverse side effects associated with such drugs.

CONCLUSIONS:

Global clinical scales such as CDR-SB and ROSA should be considered for use with treatments aiming at slowing disease progression.

PMID:
23942173
DOI:
10.1159/000353748
[Indexed for MEDLINE]

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