OBJECTIVES: To review clinical evidence of digital therapeutics (DTx) in Alzheimer’s Disease, Dementia and Mild Cognitive Impairment.

METHODS: A pragmatic literature review was conducted in Google Scholar, Clinicaltrials.gov and PubMed; using search terms for: Digital Therapeutics, Alzheimer’s Disease, Dementia and Mild Cognitive Impairment. Search results were screened against inclusion criteria of identifying DTx clinical studies with efficacy and safety endpoints. Data was extracted from selected studies using PICOS framework for further qualitative analysis.

RESULTS: 12 DTx interventions were included for analysis. DTx treatment approaches reported: cognitive training (n= 5), reminiscence therapy (n= 2), cognitive stimulation therapy (n= 2), behavioral intervention (n= 2), speech and language therapy (SALT) (n= 1), gamma sensory stimulation (n= 1). Indications reported were: Alzheimer's Disease (n=8), Dementia (n=6), Mild Cognitive Impairment (MCI) (n=5), Subjective Cognitive Decline (n=4). Outcomes measures reported include: activities of daily life (ADL), behavioral and psychological symptoms of Dementia (BPSD). Mini-mental state examination (MMSE) and using neuropsychological test battery (NTB) widely used for various domains as the primary scale for demonstrating role of intervention on cognitive function. For evaluating basic and instrumental activities of daily living, Alzheimer’s disease cooperative study scale (ADCS-ADL) was widely used.

CONCLUSIONS: Based on DTx specific treatment approach, specialized scales and outcomes measures are not consistently reported across studies making prospective meta-analyses difficult to interpret. It may be difficult to benchmark DTx treatment against the pharmaceutical products in development due to both study designs and outcome measures differences. DTx advantages include, safety due to being less invasive, lower threat of systemic toxicity and bypassing the challenge of drug delivery across the blood brain barrier. DTx generate a lot of patient data that can lead to greater understanding of disease processes and development of holistic outcome measures.