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

NCT ID: NCT05059353

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-08-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with MCI

Group Type: EXPERIMENTAL

Digitally based multidomain intervention

Intervention Type: DEVICE

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.

Cognitively Normal Subjects

Group Type: EXPERIMENTAL

Digitally based multidomain intervention

Intervention Type: DEVICE

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.

Caregivers of Patients with MCI

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

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

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

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.

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Neuroglee Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kok-Pin Ng, MBBS

Role: PRINCIPAL_INVESTIGATOR

National Neuroscience Institute

Locations

National Neuroscience Institute

Singapore, , Singapore

Countries

Singapore

References

Rykov YG, Ng KP, Patterson MD, Gangwar BA, Kandiah N. Predicting the severity of mood and neuropsychiatric symptoms from digital biomarkers using wearable physiological data and deep learning. Comput Biol Med. 2024 Sep;180:108959. doi: 10.1016/j.compbiomed.2024.108959. Epub 2024 Jul 31.

Reference Type: DERIVED

PMID: 39089109 (View on PubMed)

Other Identifiers

NG-001

Identifier Type: -

Identifier Source: org_study_id