Clinical trial NCT05059353: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Neuroglee Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-09-28
Enrollment: 55
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This study comprises three study populations: patients with MCI, cognitively normal subjects, and caregivers of the patients with MCI.
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: Change from baseline in processing speed
timeFrame: Baseline compared to Week 11
measure: Change from baseline in executive functioning
timeFrame: Baseline compared to Week 11
measure: Change from baseline in mood using the Depression Anxiety Stress Scales (DASS-21) in patients with MCI
timeFrame: Baseline compared to Week 11
Secondary outcomes:
measure: Change from baseline in overall cognition in patients with MCI
timeFrame: Baseline compared to Week 11
measure: Change from baseline in QoL
timeFrame: Baseline compared to Week 11
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Neuroscience Institute
Study officials:
affiliation: National Neuroscience Institute
name: Kok-Pin Ng, MBBS
role: PRINCIPAL_INVESTIGATOR
References: