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

NCT05059353 | Completed

• 1 other identifier: NG-001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change from baseline in overall cognition in patients with MCI

  Baseline compared to Week 11

• Change from baseline in QoL

  Baseline compared to Week 11

Study Arms (3)

Patients with MCI

EXPERIMENTAL

Device: Digitally based multidomain intervention

Cognitively Normal Subjects

EXPERIMENTAL

Device: Digitally based multidomain intervention

Caregivers of Patients with MCI

NO INTERVENTION

Interventions

Digitally based multidomain intervention 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; Patients with MCI

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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
• 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.
• Either male or female aged ≥21 years

Sponsors & Collaborators

• Neuroglee Therapeutics: lead

Study Sites (1)

National Neuroscience Institute

Singapore, 308433, Singapore

Location

Related Publications (1)

• 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.

  PMID: 39089109 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kok-Pin Ng, MBBS

  National Neuroscience Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 28, 2021
• Study Start: November 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)