🏛️ Verified NIH Record • Updated 2026-04-30

Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad (NCT06408103)

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Universidad de Santander

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Universidad de Santander / Universidad Manuela Beltrán /FOSCAL — Bucaramanga, Santander Department

Age range: 55 Years

🧪 Interventions in This Study

  • Multi-component, transdisciplinary and multifocal intervention for the cognition (OTHER)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (1 Sites)

  • Universidad de Santander / Universidad Manuela Beltrán /FOSCAL — Bucaramanga, Santander Department

📞 Contact the Study Coordinator

Phone: +57 (607) 6516500

Email: dia.tiga@mail.udes.edu.co

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗