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

Neuroglee Therapeutics55 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mild Cognitive Impairment

Interventions

Digitally based multidomain interventionDEVICE

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Neuroscience Institute

Singapore, Singapore

Outcomes

Primary Outcomes

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