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Clinical Trial Summary

Previous studies have showed that computerized cognitive training can improve cognitive function in patients with MCI, but the effect of multimodal cognitive interventions on MCI remains controversial. This study is designed to evaluate the preliminary effectiveness and safety of a digitally based multidomain intervention in patients with MCI. In addition, a portion of cognitively normal subjects and caregivers of patients with MCI will also be recruited as an exploratory cohort.

Clinical Trial Description

Mild cognitive impairment (MCI) is a syndrome defined as cognitive decline greater than that expected for an individual's age and education level but that does not interfere notably with activities of daily life. It is a transitional state between normal aging and dementia. While MCI patients may progress to dementia or revert to normal cognition, a large proportion of MCI patients may remain clinically stable (i.e., evidencing neither progression nor reversion) for their entire observed clinical course. A meta-analysis of 41 MCI studies identified the annual progression rate to dementia from MCI as 10% in clinical settings and 5% in community settings. This result suggests that the annual MCI progression rate is low (5-10%) and a larger proportion of MCI patients do not progress to dementia. A review article even reported that the incidence rate of MCI reversion to be 30-50% compared to the MCI progression rate of 4-40% with 2-5 years follow-up. A meta-analysis of 25 studies found an overall amnestic MCI reversion rate of approximately 24%. Common factors related to MCI reversion include genetics (i.e., fewer APOE ε4 alleles), global functioning (i.e., lower scores on Clinical Dementia Rating [CDR] Scale), subtype of MCI (i.e., non-amnestic single domain), cognitive functioning (i.e., higher standard scores on cognitive assessments), and neuroimaging (i.e., large hippocampal volumes). Currently, there is no pharmacological treatment that is approved for MCI. There is some evidence that suggests non-pharmacological interventions, such as cognitive training and physical exercise, may be beneficial for patients with MCI. Appropriate strategies to treat MCI and prevent the progressive decline of cognitive functions are the periodic monitoring of patients, providing lifestyle guidance, treating lifestyle-related diseases, and training on cognitive function. According to the Digital Therapeutics Alliance, digital therapeutics (DTx) is defined as "evidence-based therapeutic interventions driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease, which can be used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes". With the rising demand for innovative mental health solutions, also advances in and the increasingly dominant role of mobile technology and artificial intelligence in modern lives have broadened the role of DTx in healthcare. DTx has emerged as a new therapeutic modality for the prevention, management, or treatment of chronic, behavior-modifiable disease, which also allows clinicians to remotely collect real-time data from patients, making subsequent clinic visits more efficient. To date, DTx have largely targeted neurological and psychiatric conditions with significant unmet needs that are challenging to manage with existing therapeutics in adults or pediatrics, including substance use disorder (reSET®), opioid use disorder (reSET-O®), chronic insomnia (SomrystTM), post-traumatic stress disorder (NightWareTM), and attention deficit hyperactivity disorder (EndeavorRxTM). Akin to biopharmaceuticals and medical devices, DTx undergoes review and are cleared or approved by the U.S. Food and Drug Administration (FDA) and are either available over-the-counter or prescribed by physicians. DTx for the treatment of MCI is under development and being studied, mostly targeted to improve overall cognition or specific domains (such as learning and memory, attention, speed, executive functioning), as well as daily living skills such as financial knowledge or driving performance. A systematic review evaluating the effects of computerized cognitive training or rehabilitation interventions for individuals with MCI found that both general and domain-specific cognitive training have led to improved cognition, primarily in memory, but with some evidence that executive function may also be positively affected. The study device is a DTx intended to be used in the treatment of MCI. It is based on principles of cognitive stimulation which will be delivered in a sequence of modules of patient education, physical training, and cognitive games. Currently, there is no pharmacological treatment that is approved for MCI. Novel, cost-effective, and easy to implement/disseminate non-pharmacological interventions for MCI could be helpful for the disease population given the unmet medical need. With a small sample size, this study will investigate the preliminary effectiveness of the study device as well as its safety for the treatment of MCI. In addition, a portion of cognitively normal subjects and caregivers of patients with MCI will also be recruited as an exploratory cohort. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05059353
Study type Interventional
Source Neuroglee Therapeutics
Contact Jean Seah
Phone +65 93360851
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 2021
Completion date June 2022

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