Mild Cognitive ImpairmentNCT06453746
Effectiveness of Non-pharmacological Interventions for Dementia Prevention in Elderly Patients With Mild Cognitive Impairment
A study testing Home-based cognitive training exercises and Supervised cognitive training exercises in people with Mild Cognitive Impairment and Dementia Prevention, run by Gia Dinh People Hospital at 1 site in Vietnam.
Trial summary
The aims of this study is to evaluate the effectiveness of non-pharmacological interventions program in preventing progression from mild cognitive impairment to dementia in patients with mild cognitive impairment in the short term, at Nhân dân Gia Định Hospital, Hồ Chí Minh City. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Dementia Prevention
- What is being tested?
- Home-based cognitive training exercises and Supervised cognitive training exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteVietnam
- Study dates
- 26 Aug 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with mild cognitive impairment:
- Cognitive complaints from the subject or a family member.
- Report a decline in cognitive function compared to the subject's previous ability over the past year OR
- Evidence from clinical assessment, specifically here is MMSE screening with results of 24-29 points.
- Subjects did not suffer major impacts from cognitive complaints on daily life.
- No prior diagnosis of dementia.
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- Ensure transportation from living location to hospital.
- Have at least one relative or caregiver who can supervise the subject's daily activities.
- Stable chronic underlying conditions (diabetes, hypertension).
- Consent to participate in the study.
Who cannot join
- Don't know Vietnamese writing.
- Audio-visual ability does not meet the requirements of assessment tests and prevention programs.
- Systemic diseases are contraindications/ restriction to participation in programs and/or cause secondary cognitive impairment (traumatic brain injury, stroke, brain tumor, parkinsonism, epilepsy, acute coronary artery disease, acute myocardial infarction, bone fractures...).
- The assessment score on the Geriatric Depression Scale (GDS-15) is ≥ 5 points.
- Diagnosed with other mental disorders that may limit the ability to understand, communicate and work in groups (schizophrenia, mania, bipolar disorder, dissociative disorder, generalized anxiety disorder).
- Currently participating in another research program on dementia prevention or a research program on medication to prevent dementia within the last 3 months.
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- Taking medications that may affect cognitive function, such as benzodiazepines, hypnotics, and antipsychotics.
- Alcohol abuse: drinking alcohol daily or consuming more than 14 units of alcohol per week (equivalent to 10 grams of ethanol, as defined by the Ministry of Health); diagnosed with alcohol dependence or currently being treated for mental illness due to alcohol dependence.
- Do not agree to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Nhân dân Gia Định Hospital
Ho Chi Minh City
Hai H. Nguyen, Phd, +84908247359, bsnguyenhoanghai@gmail.com
About this study
Official title: Effectiveness of Dementia Prevention in Elderly Patients With Mild Cognitive Impairment at Nhân dân Gia Định Hospital, Hồ Chí Minh City
The aims of this study is to evaluate the effectiveness of non-pharmacological interventions program in preventing progression from mild cognitive impairment to dementia in patients with mild cognitive impairment in the short term, at Nhân dân Gia Định Hospital, Hồ Chí Minh City.
Read the detailed description
A non-pharmacological interventions program in dementia prevention is highly promising because: (i) the results of using drugs (e.g. cholinesterase inhibitors) have not been successful, so non-pharmacological interventions may be a promising and risk-free alternative; (ii) people with mild cognitive impairment still maintain memory capacity that allows them to learn and apply new information and skills; (iii) interventions at an early stage of the cognitive decline process will bring maximum benefits; (iv) there is evidence that cognitive training exercises have a positive effect on cognitive decline and are one of protective factors against dementia.
Although studies on non-pharmacological prevention programs with cognitive training exercises as a key component are not uncommon, we found that there are still some unclear points. First and foremost, there has been no cognitive training exercises in Vietnamese that has been studied. Most use foreign language communication, making language-related stimuli inapplicable in Vietnam. Next, the exercise design either focuses on improving thinking and flexibility, which is more suitable for younger people, or only prioritizes impacting certain cognitive domains. Finally, many current programs are integrated as technology applications on phones, which, although convenient, are not really user-friendly for the elderly in Vietnam due to habits, operating system response delays, and equipment costs.
- Conditions
- Mild Cognitive Impairment, Dementia Prevention
- Being tested
- Home-based cognitive training exercises, Supervised cognitive training exercises
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based cognitive training exercisesOther
The subjects received (i) education on lifestyle modification, (ii) home-based cognitive training exercises with physiotherapist/ physiatrist contact when needed and (iii) a physical training exercises conducted at hospital under the supervision of physiotherapist/ physiatrist (3 weekly session for 12 weeks).
This arm has a duration of 12 weeks.
Supervised cognitive training exercisesOther
The subjects received (i) education on lifestyle modification, (ii) supervised cognitive training exercises at hospital (1 weekly session for 12 weeks) and (iii) a physical training exercises conducted in a hospital under the supervision of physiotherapist/ physiatrist (3 weekly session for 12 weeks).
This arm has a duration of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Home-based cognitive training exercises | Active comparator | The cognitive training exercises program includes a total of 19 exercises and activities. The 19 exercises are divided into 8 groups: (1) warm up and cool down (relaxation exercise), (2) episodic memory, (3) digit span and calculation, (4) language, (5) Linking Letters \& Numbers, (6) Imagery, (7) Visuoconstructional skills, (8) linking ADL/IADL tasks.
Subjects are provided with 19 exercises and instructed to perform them at home. Home-based exercises will be assessed weekly. Subjects are provided with a logbook to track their progress with the home exercises and were given the opportunity to provide feedback, ask questions, and receive support for any difficulties encountered during the process.
All cognitive training exercises are based on the Technical Procedure Instructions issued by the Vietnamese Ministry of Health. Receives: Other: Home-based cognitive training exercises |
| Supervised cognitive training exercises | Experimental | The cognitive training exercises program includes a total of 19 exercises and activities. The 19 exercises are divided into 8 groups: (1) warm up and cool down (relaxation exercise), (2) episodic memory, (3) digit span and calculation, (4) language, (5) Linking Letters \& Numbers, (6) Imagery, (7) Visuoconstructional skills, (8) linking ADL/IADL tasks.
The subjects are given exercises at the hospital under the supervision of physiotherpist/ physiatrist, and are also instructed to do the exercises at home.
Home-based exercises will be assessed weekly. Subjects are provided with a logbook to track their progress with the home exercises and were given the opportunity to provide feedback, ask questions, and receive support for any difficulties encountered during the process.
All cognitive training exercises are based on the Technical Procedure Instructions issued by the Vietnamese Ministry of Health. Receives: Other: Supervised cognitive training exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Intervention Program
Evaluating the effectiveness of preventing progression from mild cognitive impairment to dementia using the Montreal Cognitive Assessment (The MoCA Test) in patients with mild cognitive impairment in the short term. Higher scores mean a better outcome. The following result ranges may indicate cognitive impairment: 18-25 points: Mild cognitive impairment. 10-17 points: Moderate cognitive impairment. Fewer than 10 points: Severe cognitive impairment.
Measured: Measured at month 3 and 6 after randomisation
Secondary outcomes (5)
Change in Activities of Daily Living
Evaluating improvement using The Lawton Instrumental Activities of Daily Living Scale (IADL). Higher scores mean a better outcome.
Measured: Baseline, Week12, Week24
Change in physical fitness
Evaluating improvement using The Senior Fitness Test Kit (Chair stand test, Arm curl test, Step in place test, Up and go test). Higher scores mean a better outcome (except Up and go test).
Measured: Baseline, Week12, Week24
Change in mental health
Evaluating improvement using Geriatric Depression Scale-15 (GDS15). Higher scores mean a worse outcome.
Measured: Baseline, Week12, Week24
Patient Adherance
Adherence is assessed considering the number of individuals who have accepted to participate in the study relative to the number of participants who are recruited. Low < 80%, moderate 80-90%, high > 90%
Measured: Week12
Patient Attendance
Attendance rate is calculated as a percentage of the number of exercise sessions completed by participants by the full amount of sessions they are expected to perform throughout the study. Not achieved < 90%
Measured: Week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start26 Aug 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gia Dinh People Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453746
- Sponsor's protocol ID
- 625/HĐĐĐ-ĐHYD
- Status last verified
- Sep 2024
- First submitted
- 31 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in dementia prevention. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dementia Prevention in Elderly Patients With Mild Cognitive Impairment at Nhân dân Gia Định Hospital, Hồ Chí Minh City
- ClinicalTrials.gov ID
- NCT06453746
- Acronym / sponsor ID
- 625/HĐĐĐ-ĐHYD
- Conditions
- Mild Cognitive Impairment, Dementia Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Gia Dinh People HospitalUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jun 2024 (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.
The aims of this study is to evaluate the effectiveness of non-pharmacological interventions program in preventing progression from mild cognitive impairment to dementia in patients with mild cognitive impairment in the short term, at Nhân dân Gia Định Hospital, Hồ Chí Minh City.
Detailed description
A non-pharmacological interventions program in dementia prevention is highly promising because: (i) the results of using drugs (e.g. cholinesterase inhibitors) have not been successful, so non-pharmacological interventions may be a promising and risk-free alternative; (ii) people with mild cognitive impairment still maintain memory capacity that allows them to learn and apply new information and skills; (iii) interventions at an early stage of the cognitive decline process will bring maximum benefits; (iv) there is evidence that cognitive training exercises have a positive effect on cognitive decline and are one of protective factors against dementia.
Although studies on non-pharmacological prevention programs with cognitive training exercises as a key component are not uncommon, we found that there are still some unclear points. First and foremost, there has been no cognitive training exercises in Vietnamese that has been studied. Most use foreign language communication, making language-related stimuli inapplicable in Vietnam. Next, the exercise design either focuses on improving thinking and flexibility, which is more suitable for younger people, or only prioritizes impacting certain cognitive domains. Finally, many current programs are integrated as technology applications on phones, which, although convenient, are not really user-friendly for the elderly in Vietnam due to habits, operating system response delays, and equipment costs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based cognitive training exercises | Active comparator | Other: Home-based cognitive training exercisesThe cognitive training exercises program includes a total of 19 exercises and activities. The 19 exercises are divided into 8 groups: (1) warm up and cool down (relaxation exercise), (2) episodic memory, (3) digit span and calculation, (4) language, (5) Linking Letters \& Numbers, (6) Imagery, (7) Visuoconstructional skills, (8) linking ADL/IADL tasks. Subjects are provided with 19 exercises and instructed to perform them at home. Home-based exercises will be assessed weekly. Subjects are provided with a logbook to track their progress with the home exercises and were given the opportunity to provide feedback, ask questions, and receive support for any difficulties encountered during the process. All cognitive training exercises are based on the Technical Procedure Instructions issued by the Vietnamese Ministry of Health. |
| Supervised cognitive training exercises | Experimental | Other: Supervised cognitive training exercisesThe cognitive training exercises program includes a total of 19 exercises and activities. The 19 exercises are divided into 8 groups: (1) warm up and cool down (relaxation exercise), (2) episodic memory, (3) digit span and calculation, (4) language, (5) Linking Letters \& Numbers, (6) Imagery, (7) Visuoconstructional skills, (8) linking ADL/IADL tasks. The subjects are given exercises at the hospital under the supervision of physiotherpist/ physiatrist, and are also instructed to do the exercises at home. Home-based exercises will be assessed weekly. Subjects are provided with a logbook to track their progress with the home exercises and were given the opportunity to provide feedback, ask questions, and receive support for any difficulties encountered during the process. All cognitive training exercises are based on the Technical Procedure Instructions issued by the Vietnamese Ministry of Health. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects diagnosed with mild cognitive impairment:
- Ensure transportation from living location to hospital.
- Have at least one relative or caregiver who can supervise the subject's daily activities.
- Stable chronic underlying conditions (diabetes, hypertension).
- Consent to participate in the study.
Key exclusion criteria (9 listed)
- Don't know Vietnamese writing.
- Audio-visual ability does not meet the requirements of assessment tests and prevention programs.
- Systemic diseases are contraindications/ restriction to participation in programs and/or cause secondary cognitive impairment (traumatic brain injury, stroke, brain tumor, parkinsonism, epilepsy, acute coronary artery disease, acute myocardial infarction, bone fractures...).
- The assessment score on the Geriatric Depression Scale (GDS-15) is ≥ 5 points.
- Diagnosed with other mental disorders that may limit the ability to understand, communicate and work in groups (schizophrenia, mania, bipolar disorder, dissociative disorder, generalized anxiety disorder).
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 |
|---|---|---|
| Home-based cognitive training exercisesThe subjects received (i) education on lifestyle modification, (ii) home-based cognitive training exercises with physiotherapist/ physiatrist contact when needed and (iii) a physical training exercises conducted at hospital under the supervision of physiotherapist/ physiatrist (3 weekly session for 12 weeks). This arm has a duration of 12 weeks. | Other | Home-based cognitive training exercises |
| Supervised cognitive training exercisesThe subjects received (i) education on lifestyle modification, (ii) supervised cognitive training exercises at hospital (1 weekly session for 12 weeks) and (iii) a physical training exercises conducted in a hospital under the supervision of physiotherapist/ physiatrist (3 weekly session for 12 weeks). This arm has a duration of 12 weeks. | Other | Supervised cognitive training exercises |
Primary outcome
Effectiveness of Intervention Program
Time frame: Measured at month 3 and 6 after randomisation
Evaluating the effectiveness of preventing progression from mild cognitive impairment to dementia using the Montreal Cognitive Assessment (The MoCA Test) in patients with mild cognitive impairment in the short term. Higher scores mean a better outcome. The following result ranges may indicate cognitive impairment: 18-25 points: Mild cognitive impairment. 10-17 points: Moderate cognitive impairment. Fewer than 10 points: Severe cognitive impairment.
5 secondary outcomes
Change in Activities of Daily Living
Time frame: Baseline, Week12, Week24
Change in physical fitness
Time frame: Baseline, Week12, Week24
Change in mental health
Time frame: Baseline, Week12, Week24
Patient Adherance
Time frame: Week12
Patient Attendance
Time frame: Week12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in dementia prevention. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based cognitive training exercises and Supervised cognitive training exercises in people with Mild Cognitive Impairment and Dementia Prevention, run by Gia Dinh People Hospital at 1 site in Vietnam.
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 10 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khai Q. Nguyen, M.D (+84704674558, nguyenquangkhai2209@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Intervention Program (time frame: Measured at month 3 and 6 after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.