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Digital Cognitive Testing in Mitochondrial Disease: Validity and Challenges for Clinical Trial Use
Oksana Pogoryelova1,2,3, Jan Smeitink4, Herma Renkema4
1Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
Annals of Clinical and Translational Neurology
|July 31, 2026
Summary
Digital cognitive tests effectively measure cognitive decline in primary mitochondrial diseases, correlating well with traditional methods. This aids in selecting sensitive endpoints for clinical trials in these progressive neurodegenerative conditions.
Area of Science:
- Neuroscience
- Genetics
- Clinical Trials
Background:
- Primary mitochondrial disease involves genetic mutations affecting energy production, leading to progressive neurodegeneration and cognitive impairment.
- Current treatments are supportive; disease-modifying therapies are under development, necessitating sensitive clinical trial endpoints.
- Identifying reliable cognitive outcomes is crucial for evaluating new treatments in mitochondrial diseases.
Purpose of the Study:
- To compare digital cognitive assessments with traditional methods for efficiency and sensitivity in primary mitochondrial disease research.
- To identify optimal cognitive endpoints for clinical trials in patients with mitochondrial diseases.
Main Methods:
- Two cohorts (Newcastle: 45 patients; KHENERGYZE: 27 patients) were studied.
- Digital cognitive tests (Cogstate, Test of Attentional Performance) were compared against traditional assessments (Addenbrooke's Cognitive Examination, Montreal Cognitive Assessment).
- Confounding factors like education and employment were assessed.
Main Results:
- High prevalence of fatigue and reduced reaction times observed in both cohorts.
- Strong correlations found between digital and traditional cognitive assessment tools.
- Education and employment status influenced cognitive performance.
Conclusions:
- Digital cognitive assessments are viable alternatives to traditional methods for evaluating cognitive function in mitochondrial diseases.
- Cognitive impairment is a key feature of slowly progressive mitochondrial diseases, even without severe neurological symptoms.
- Variability in cognitive performance can be leveraged to detect meaningful changes in clinical trials.
