Actively Recruiting
Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad
Led by Universidad de Santander · Updated on 2026-05-07
102
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
U
Universidad de Santander
Lead Sponsor
U
Universidad Manuela Beltrán
Collaborating Sponsor
AI-Summary
What this Trial Is About
With the aging of the population, an increase in neurocognitive diseases such as dementia is projected. Mild cognitive impairment is considered a precursor stage to dementia, with opportunities for intervention to prevent its progression. Additionally, these illnesses can harm the primary caregiver, who is often an unskilled family member. This is a randomized clinical trial in patients with mild cognitive impairment and their main caregivers. The intervention will be tested in the dyad for 12 weeks, twice a week with professional support and once a week with caregiver support, the latter will be intervened once a week for 12 weeks. The primary outcome will be the change in cognitive function and its domains. Secondary outcomes will evaluate favorable changes in quality of life in the patient-caregiver couple, frailty, physical capacity, independence, nutritional status, social support, and family caregiver burden. These measurements will be taken at baseline, 3, 6, and 9 months of follow-up. Furthermore, in a subsample of the study population, the taxonomic and metabolomic composition of the intestinal microbiota and the presence of the E4 allele of the APOE (apolipoprotein E) gene will be evaluated before and after the intervention.
CONDITIONS
Official Title
Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 55 years or older
- Diagnosis of mild cognitive impairment by a Psychiatrist or Neurologist supported by neuropsychological evaluation
- Ability to perform instrumental activities of daily living
- Basic reading and writing skills
- No untreated hearing impairment or uncorrected visual problems
- Availability of a primary family caregiver
- Low level of physical activity based on IPAQ
- Barthel Index score of 80 points or higher
- Ability to walk short distances without permanent mechanical aids
- Body mass index (BMI) above 18.5
- No surgical resections of the gastrointestinal tract
- Tolerance to oral feeding
- Vaccination against COVID-19
- Caregivers must be adults aged 18 years or older
- Caregivers must have basic reading and writing skills
- Caregivers must have a family relationship (consanguineous or non-consanguineous)
- Caregivers must be vaccinated against COVID-19
You will not qualify if you...
- History of psychosis or congenital intellectual disability
- Central nervous system diseases affecting cognition, such as Parkinson's disease, tumors, encephalitis, epilepsy, stroke, or traumatic brain injury
- Untreated psychiatric disorders including anxiety or depression
- Clinically significant systemic diseases like thyroid dysfunction, vitamin B12 deficiency, insulin-dependent diabetes, syphilis, HIV, Epstein Barr infection, advanced kidney failure, or liver cirrhosis
- Chronic kidney disease or liver diseases such as hepatitis or cirrhosis
- Pulmonary diseases requiring oxygen support, Crohn's disease, or colitis
- Current or past cancer treated with chemotherapy
- Use of probiotics or prebiotics in the last 30 days
- Active infectious diarrhea
- Current or past abuse of alcohol, tobacco, or drugs
- Use of steroids or immunosuppressants in the last 30 days
- Recent use of systemic antibiotics, antifungals, or antivirals in the last 3 months
- Withdrawal from the study by choice
- Lack of nutritional support (oral, enteral, or parenteral)
- Poor exercise tolerance, vertigo, or medical restrictions on exercise
- Institutionalization or hospitalization for more than 1 week during the intervention
- Missing more than 34% of professional accompaniment sessions by the patient-caregiver pair
AI-Screening
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Trial Site Locations
Total: 1 location
1
Universidad de Santander / Universidad Manuela Beltrán /FOSCAL
Bucaramanga, Santander Department, Colombia, 62215
Actively Recruiting
Research Team
D
Diana Tiga Loza, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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