Improving cognitive function for patients with mild cognitive impairment and their caregivers

Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad

This study tests a new support program to see if it can help improve thinking skills for people with mild cognitive impairment and also support their caregivers.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 55 Years and up
• Sex: All
• Sponsor: Universidad de Santander (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Bucaramanga, Santander Department)
• Trial ID: NCT06408103 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a multicomponent intervention designed to enhance cognitive function in patients with mild cognitive impairment and their primary caregivers. The intervention consists of professional support sessions twice a week and caregiver support sessions once a week over a 12-week period. The study aims to assess changes in cognitive function and various quality of life metrics for both the patient and caregiver. Measurements will be taken at baseline, 3, 6, and 9 months to determine the intervention's impact.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 55 and older diagnosed with mild cognitive impairment who have a primary family caregiver.

Not a fit: Patients with a history of psychosis or congenital intellectual disability may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this intervention could significantly improve cognitive function and quality of life for both patients and their caregivers.

How similar studies have performed: Previous studies have shown that multicomponent interventions can be more effective than single-domain approaches in improving cognitive function in older adults.

Eligibility criteria

Inclusion and exclusion criteria for elderly adults

Inclusion criteria

1. Age of 55 years or older.
2. Diagnosis of mild cognitive impairment by a Psychiatrist/Neurologist supported by neuropsychological evaluation.
3. Functionality for instrumental activities.
4. Basic proficiency in reading and writing.
5. Absence of untreated hearing impairment and/or uncorrected visual problems.
6. Availability of a primary family caregiver (to be identified).
7. IPAQ with low level of physical activity (pending cutoff point), PARQ and you Fit (pending review).
8. Barthel Index equal to or greater than 80 points.
9. Functional capacity for short-distance ambulation without permanent use of mechanical aids such as wheelchairs.
10. Individuals with a BMI greater than 18.5.
11. Gastrointestinal tract without surgical resections.
12. Tolerance to oral feeding.
13. Vaccination against COVID-19.

Exclusion criteria

1. History of psychosis or congenital intellectual disability.
2. Presence of a central nervous system pathology that could affect cognition (Parkinson's disease, tumors, encephalitis, epilepsy, cerebrovascular disease, traumatic brain injury).
3. Presence of untreated psychiatric disorders, anxiety, depression (Yesavage).
4. Presence of clinically significant systemic diseases (thyroid dysfunction, vitamin B12 deficiency, insulin-dependent diabetes, syphilis, HIV infection, Epstein Barr infection, advanced stage renal failure, cirrhosis). Evaluated through medical history and self-report.
5. Older adult with Chronic Kidney Disease, Hepatopathies (hepatitis, liver cirrhosis),
6. Pulmonary Diseases, or requiring oxygen support, Crohn's Disease, and Colitis.
7. Individual with oncological pathology who has received or is receiving chemotherapy.
8. Individual who has received probiotics or prebiotics in the last 30 days.
9. Presence of clinically significant, active infectious etiology diarrhea.
10. Current or prior abuse of alcohol, tobacco, or drugs.
11. Use of steroids or immunosuppressants in the last 30 days.
12. Recent use of antibiotics, antifungals, or antivirals (excluding topicals) in the last 3 months.
13. Individual who voluntarily decides to withdraw from the study.
14. Older adult without oral, enteral, or parenteral nutritional support.
15. Poor tolerance to exercise, vertigo, medical exercise restriction.

Elimination criteria

1. Institutionalized or hospitalized for more than 1 week, or death during the intervention phase (review and clarity on death).
2. Failure to attend more than 34% of sessions with professional accompaniment (applies to the dyad).

Inclusion and exclusion criteria for caregivers ( Family members)

Inclusion criteria

1. Adults aged 18 years or older.
2. Basic proficiency in reading and writing.
3. Having a level of kinship (consanguineous or non-consanguineous).
4. Vaccination against COVID-19.

Where this trial is running

Bucaramanga, Santander Department

• Universidad de Santander / Universidad Manuela Beltrán /FOSCAL — Bucaramanga, Santander Department, Colombia (Recruiting)

Study contacts

• Study coordinator: Diana Tiga Loza, Ph.D

Conditions Mild Cognitive Impairment; Rehabilitation; Informal caregiver; Transdisciplinary intervention; Multi-component intervention; Cognitive dysfunction