Mild Cognitive ImpairmentNCT05059353
Effectiveness and Safety of a Digitally Based Multidomain Intervention for Mild Cognitive Impairment
A study testing Digitally based multidomain intervention in people with Mild Cognitive Impairment, run by Neuroglee Therapeutics at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Digitally based multidomain intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Nov 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- Willing to give informed consent
- 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
- 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
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Clinical Trial to Study the Effectiveness and Safety of a Digitally Based Multidomain Intervention for Mild Cognitive Impairment
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.
Read the 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
- Being tested
- Digitally based multidomain intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MCI | Experimental | Not described Receives: Device: Digitally based multidomain intervention |
| Cognitively Normal Subjects | Experimental | Not described Receives: Device: Digitally based multidomain intervention |
| Caregivers of Patients with MCI | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: Baseline compared to Week 11
Secondary outcomes (2)
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.
Measured: Baseline compared to Week 11
Change from baseline in QoL
Using QOL-AD questionnaire in patients with MCI
Measured: Baseline compared to Week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 Nov 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuroglee Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kok-Pin Ng, MBBS, Principal investigator, National Neuroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059353
- Sponsor's protocol ID
- NG-001
- Status last verified
- Oct 2022
- First submitted
- 30 Aug 2021
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39089109
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Clinical Trial to Study the Effectiveness and Safety of a Digitally Based Multidomain Intervention for Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05059353
- Acronym / sponsor ID
- NG-001
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Neuroglee TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study comprises three study populations: patients with MCI, cognitively normal subjects, and caregivers of the patients with MCI.
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
- Significant hearing or visual impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digitally based multidomain interventionEducation (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. | Device | Cognitively Normal Subjects, Patients with MCI |
Primary outcome
Change from baseline in processing speed
Time frame: Baseline compared to Week 11
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
Time frame: Baseline compared to Week 11
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
Time frame: Baseline compared to Week 11
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.
2 secondary outcomes
Change from baseline in overall cognition in patients with MCI
Time frame: Baseline compared to Week 11
Change from baseline in QoL
Time frame: Baseline compared to Week 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 39089109Rykov 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kok-Pin Ng, MBBS principal investigator
National Neuroscience Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitally based multidomain intervention in people with Mild Cognitive Impairment, run by Neuroglee Therapeutics at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in processing speed (time frame: Baseline compared to Week 11). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05059353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.