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

Open Label Clinical Trial to Study the Effectiveness and Safety of a Digitally Based Multidomain Intervention for Mild Cognitive Impairment

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Device: Digitally based multidomain intervention

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 308433
    • National Neuroscience Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Patients with MCI Thirty (30) patients with MCI of the amnestic type (single or multi domain) will be recruited. MCI will be diagnosed using the Petersen's criteria and/or the NIA-AA criteria by cognitive neurologists.

Inclusion criteria:

1. Either male or female aged between 50 and 70 years (inclusive)
2. Diagnosis of amnestic MCI using the Petersen's criteria and/or the NIA-AA criteria
3. Clinical Dementia Rating (CDR) score of 0.5 and Mini-Mental State Examination (MMSE) >24
4. Education >6 years
5. Literate in English
6. Basic proficiency in using web-based applications/mobile platforms
7. Willing to give informed consent

Exclusion criteria:

1. Significant hearing or visual impairment
2. Significant systemic, neurological or psychiatric illness such as end stage renal failure, Parkinson's disease or major depression.
3. Participation in any pharmacological or non-pharmacological (interventional) clinical trial in the preceding 12 weeks

Cognitively Normal Subjects Ten (10) cognitively normal subjects will be recruited.

Inclusion criteria:

1. Either male or female aged between 50 and 70 years (inclusive)
2. CDR of 0 and MMSE > 27
3. Education >6 years
4. Literate in English
5. Basic proficiency in using web-based applications/mobile platforms
6. Willing to give informed consent

Exclusion criteria:

1. Significant hearing or visual impairment
2. Significant systemic, neurological or psychiatric illness such as end stage renal failure, Parkinson's disease or major depression.
3. Participation in any pharmacological or non-pharmacological clinical trial in the preceding 12 weeks

Caregivers of Patients with MCI Fifteen (15) caregivers of the 30 patients with MCI will be recruited.

Inclusion criteria:

1. Either male or female aged ≥21 years
2. Is the spouse or child of the patient and must spend at least 2 hours per week with the patient.
3. Must be healthy and not suffering from any serious systemic, neurological or psychiatric illness.
4. Literate in English
5. Willing to give informed consent Exclusion criteria: NA

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with MCI	Device: Digitally based multidomain intervention; Education (5-10 mins). This session is to educate patients on instrumental activities of daily living such as the importance of companionship, medication, finance, home, travel, and kitchen safety. The content will be delivered using video and text-based material in English. Physical Activity (10 mins). This session includes activities such as brisk walking and yoga. Participants will be allowed to choose their preferred exercise option from the menu. Reminiscence Therapy (20 mins). This session includes recollection of events using directed questions, and a collection of photos from the past. Participants will be asked to share about any aspect related to the given topics using text or audio. Cognitive Games (20 mins). Participants will be asked to play games using their fingers to control characters on the screen to achieve goals. These games are designed to train different cognitive abilities, including attention, memory, executive functioning, and processing speed.
Experimental: Cognitively Normal Subjects	Device: Digitally based multidomain intervention; Education (5-10 mins). This session is to educate patients on instrumental activities of daily living such as the importance of companionship, medication, finance, home, travel, and kitchen safety. The content will be delivered using video and text-based material in English. Physical Activity (10 mins). This session includes activities such as brisk walking and yoga. Participants will be allowed to choose their preferred exercise option from the menu. Reminiscence Therapy (20 mins). This session includes recollection of events using directed questions, and a collection of photos from the past. Participants will be asked to share about any aspect related to the given topics using text or audio. Cognitive Games (20 mins). Participants will be asked to play games using their fingers to control characters on the screen to achieve goals. These games are designed to train different cognitive abilities, including attention, memory, executive functioning, and processing speed.
No Intervention: Caregivers of Patients with MCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in processing speed	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	Baseline compared to Week 11
Change from baseline in executive functioning	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	Baseline compared to Week 11
Change from baseline in mood using the Depression Anxiety Stress Scales (DASS-21) in patients with MCI	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.	Baseline compared to Week 11

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Neuroglee Therapeutics
• Investigators: Principal Investigator: Kok-Pin Ng, MBBS, National Neuroscience Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: NG-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No