Effectiveness and Safety of a Digitally Based Multidomain Intervention for Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Device: Digitally based multidomain intervention

• Registration Number: NCT05059353
• Lead Sponsor: Neuroglee Therapeutics

Brief Summary

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. We hope that the digital platform will improve the overall cognition and quality of life in patients with MCI.

Detailed Description

3 groups of participants will be recruited. For the participants in the MCI (group A) and cognitively normal subjects (group B), they will be provided with a digital tablet and a wearable device. The digital tablet will be pre-loaded with 10 modules, 1 module per week (1 hour) for 10 weeks to be completed at home. The wearable device will be used to track and collect physiological data.

For the caregivers of the patients with MCI (group C), they will be asked to complete a questionnaire during screening visit and follow-up visit, and to use the caregiver app during the intervention period.

Study Timeline

• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-28
• Study Start: 2021-11-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-11
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Patients with MCI	Digitally based multidomain intervention	-
Cognitively Normal Subjects	Digitally based multidomain intervention	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in processing speed	Baseline compared to Week 11	Using Neuropsychological Test Battery (NTB) Processing Speed domain items (symbol digit modalities test, trail making test A, and Stroop test (condition 1 and 2) in patients with MCI
Change from baseline in executive functioning	Baseline compared to Week 11	Using the NTB Executive Function domain items (digit span test, verbal fluency test, similarities test from Wechsler Adult Intelligence Scale IV (WAIS-IV) and trail making test B) in patients with MCI
Change from baseline in mood using the Depression Anxiety Stress Scales (DASS-21) in patients with MCI	Baseline compared to Week 11	The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.; Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content.; The scoring ranges from 0 to 3 per item. The higher the score, the greater the sense of depression, anxiety or stress.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in overall cognition in patients with MCI	Baseline compared to Week 11	Overall cognition is tested using the Neuropsychological Test Battery (NTB). Higher scores demonstrates better performance.
Change from baseline in QoL	Baseline compared to Week 11	Using QOL-AD questionnaire in patients with MCI

Trial Locations

Locations (1)

National Neuroscience Institute; 🇸🇬 Singapore, Singapore