Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06453746

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nhân dân Gia Định Hospital

Ho Chi Minh City, Vietnam

Location status: Recruiting

Location contact

Hai H. Nguyen, Phd

CONTACT

[email protected]

+84908247359

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home-based cognitive training exercises

Other

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

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Activities of Daily Living

    Time frame: Baseline, Week12, Week24

    Evaluating improvement using The Lawton Instrumental Activities of Daily Living Scale (IADL). Higher scores mean a better outcome.

  2. Change in physical fitness

    Time frame: Baseline, Week12, Week24

    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).

  3. Change in mental health

    Time frame: Baseline, Week12, Week24

    Evaluating improvement using Geriatric Depression Scale-15 (GDS15). Higher scores mean a worse outcome.

  4. Patient Adherance

    Time frame: Week12

    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%

  5. Patient Attendance

    Time frame: Week12

    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%

Study contacts

Contact information is provided by the study sponsor or research team.

Khai Q. Nguyen, M.D

CONTACT

[email protected]

+84704674558

Kien G. To, Assoc. Prof

CONTACT

[email protected]

+84907857370

Sponsors and collaborators

Lead sponsor

Gia Dinh People Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.