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Randomized controlled trials in frontotemporal dementia: cognitive and behavioral outcomes
Justin B Miller1, Sarah J Banks1, Gabriel C Léger1
1Cleveland Clinic, Lou Ruvo Center for Brain Health, 888 W. Bonneville Ave, Las Vegas, Nevada 89106, USA.
Translational Neurodegeneration
|June 13, 2014
Summary
Developing sensitive and specific outcome measures is crucial for advancing frontotemporal dementia (FTD) treatments. Appropriate clinical trial endpoints are essential for detecting subtle changes and ensuring FTD therapy development success.
Area of Science:
- Neuroscience
- Genetics
- Molecular Biology
Background:
- Frontotemporal dementia (FTD) research is advancing in genetics and molecular biology, with identified intervention targets and ongoing clinical trials.
- FTD presents a challenge due to heterogeneous phenotypes linked to multiple pathologies, often manifesting as executive dysfunction, language impairments, and behavioral changes.
- Specific FTD variants include behavioral variant FTD (bvFTTD), Progressive Nonfluent Aphasia (PNFA), and Semantic Dementia (SD), each with distinct neuropsychological profiles.
Purpose of the Study:
- To highlight the critical need for selecting appropriate clinical trial endpoints for frontotemporal dementia (FTD).
- To discuss the challenges in measuring FTD progression and the requirements for sensitive, specific, and reliable outcome measures.
- To propose potential cognitive and behavioral measures for FTD clinical trials.
Main Methods:
- Review of current understanding of FTD genetics, molecular biology, and clinical characteristics.
- Analysis of the requirements for effective clinical trial endpoints, including sensitivity, specificity, reliability, and accessibility.
- Identification and exemplification of potential outcome measures for FTD trials, encompassing global, composite, and individual cognitive and behavioral assessments.
Main Results:
- FTD research has identified therapeutic targets and is progressing with clinical trials.
- Effective FTD clinical trial endpoints must be sensitive to small changes, specific, reliable for repeated administration, and accessible.
- Several promising cognitive and behavioral measures are available for evaluating FTD progression in clinical trials.
Conclusions:
- The development and application of appropriate trial outcomes are paramount for the successful advancement of new treatments for frontotemporal dementia (FTD).
- Careful selection of outcome measures will ensure the detection of true treatment effects and facilitate regulatory approval for FTD therapies.
Keywords:
Frontotemporal dementiaMethodsPrimary endpointsRandomized controlled trialSecondary endpoints
