Clinical trial NCT06453746: Effectiveness of Non-pharmacological Interventions for Dementia Prevention in Elderly Patients With Mild Cognitive Impairment
Official title: Effectiveness of Dementia Prevention in Elderly Patients With Mild Cognitive Impairment at Nhân dân Gia Định Hospital, Hồ Chí Minh City
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Dementia Prevention
Lead sponsor: Gia Dinh People Hospital
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 192
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of Intervention Program
timeFrame: Measured at month 3 and 6 after randomisation
Secondary outcomes:
measure: Change in Activities of Daily Living
timeFrame: Baseline, Week12, Week24
measure: Change in physical fitness
timeFrame: Baseline, Week12, Week24
measure: Change in mental health
timeFrame: Baseline, Week12, Week24
measure: Patient Adherance
timeFrame: Week12
measure: Patient Attendance
timeFrame: Week12
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Nhân dân Gia Định Hospital
Study officials:
References: