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

Primary Purpose

Mild Cognitive Impairment

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Digitally based multidomain intervention

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

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

Exclusion criteria:

Significant hearing or visual impairment
Significant systemic, neurological or psychiatric illness such as end stage renal failure, Parkinson's disease or major depression.
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:

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

Exclusion criteria:

Significant hearing or visual impairment
Significant systemic, neurological or psychiatric illness such as end stage renal failure, Parkinson's disease or major depression.
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:

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

Sites / Locations

National Neuroscience Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Patients with MCI

Cognitively Normal Subjects

Caregivers of Patients with MCI

Arm Description

Outcomes

Primary Outcome Measures

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

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

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.

Secondary Outcome Measures

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.

Change from baseline in QoL

Using QOL-AD questionnaire in patients with MCI

Full Information

NCT ID

NCT05059353

First Posted

August 30, 2021

Last Updated

October 11, 2022

Sponsor

Neuroglee Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT05059353

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

August 31, 2022 (Actual)

Study Completion Date

August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neuroglee Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

This study comprises three study populations: patients with MCI, cognitively normal subjects, and caregivers of the patients with MCI.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with MCI

Arm Type

Experimental

Arm Title

Cognitively Normal Subjects

Arm Type

Experimental

Arm Title

Caregivers of Patients with MCI

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

Digitally based multidomain intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline in processing speed

Description

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

Time Frame

Baseline compared to Week 11

Title

Change from baseline in executive functioning

Description

Time Frame

Baseline compared to Week 11

Title

Change from baseline in mood using the Depression Anxiety Stress Scales (DASS-21) in patients with MCI

Description

Time Frame

Baseline compared to Week 11

Secondary Outcome Measure Information:

Title

Change from baseline in overall cognition in patients with MCI

Description

Overall cognition is tested using the Neuropsychological Test Battery (NTB). Higher scores demonstrates better performance.

Time Frame

Baseline compared to Week 11

Title

Change from baseline in QoL

Description

Using QOL-AD questionnaire in patients with MCI

Time Frame

Baseline compared to Week 11

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Either male or female aged between 50 and 70 years (inclusive) Diagnosis of amnestic MCI using the Petersen's criteria and/or the NIA-AA criteria Clinical Dementia Rating (CDR) score of 0.5 and Mini-Mental State Examination (MMSE) >24 Education >6 years Literate in English Basic proficiency in using web-based applications/mobile platforms Willing to give informed consent Exclusion criteria: Significant hearing or visual impairment Significant systemic, neurological or psychiatric illness such as end stage renal failure, Parkinson's disease or major depression. 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: Either male or female aged between 50 and 70 years (inclusive) CDR of 0 and MMSE > 27 Education >6 years Literate in English Basic proficiency in using web-based applications/mobile platforms Willing to give informed consent Exclusion criteria: Significant hearing or visual impairment Significant systemic, neurological or psychiatric illness such as end stage renal failure, Parkinson's disease or major depression. 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: Either male or female aged ≥21 years Is the spouse or child of the patient and must spend at least 2 hours per week with the patient. Must be healthy and not suffering from any serious systemic, neurological or psychiatric illness. Literate in English Willing to give informed consent Exclusion criteria: NA

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kok-Pin Ng, MBBS

Organizational Affiliation

National Neuroscience Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Neuroscience Institute

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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