Effectiveness of Non-pharmacological Interventions for Dementia Prevention in Elderly Patients With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Effectiveness of Dementia Prevention in Elderly Patients With Mild Cognitive Impairment at Nhân dân Gia Định Hospital, Hồ Chí Minh City

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06453746
• Other study ID #: 625/HÐÐÐ-ÐHYD
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Gia Dinh People Hospital
• Contact: Khai Q. Nguyen, M.D
• Phone: +84704674558
• Email: nguyenquangkhai2209[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 192
• Est. completion date: December 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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.
• 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.

Exclusion Criteria:

• 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.
• 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

Other:
• Home-based cognitive training exercises
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 exercises
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gia Dinh People Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 at month 3 and 6 after randomisation
Secondary	Change in Activities of Daily Living	Evaluating improvement using The Lawton Instrumental Activities of Daily Living Scale (IADL). Higher scores mean a better outcome.	Baseline, Week12, Week24
Secondary	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).	Baseline, Week12, Week24
Secondary	Change in mental health	Evaluating improvement using Geriatric Depression Scale-15 (GDS15). Higher scores mean a worse outcome.	Baseline, Week12, Week24
Secondary	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%	Week12
Secondary	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%	Week12