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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 supports their use in clinical trials for this progressive neurodegenerative condition.
Area of Science:
- Neuroscience
- Genetics
- Clinical Trials
Background:
- Primary mitochondrial disease involves genetic defects impacting energy production, leading to 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 identify efficient and sensitive cognitive endpoints for translational research in primary mitochondrial disease.
- To compare the efficacy of digital cognitive assessments versus traditional methods for detecting cognitive changes.
Main Methods:
- Two cohorts (Newcastle: 45 patients; KHENERGYZE: 27 patients) were studied.
- Digital cognitive tests (Cogstate, Test of Attentional Performance) were compared with traditional assessments (Addenbrooke's Cognitive Examination, Montreal Cognitive Assessment).
- Potential confounding factors like fatigue, education, and employment were assessed.
Main Results:
- High prevalence of fatigue and reduced reaction times observed in both cohorts.
- Digital and traditional cognitive assessments showed strong correlations.
- Factors such as education and employment influenced cognitive performance.
Conclusions:
- Cognitive impairment is a key feature of primary mitochondrial disease, even without severe neurological symptoms.
- Digital cognitive assessments are viable tools for detecting subtle cognitive changes in clinical trials.
- Variability in cognitive performance can aid in tracking disease progression and treatment effects.
