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

Access comprehensive clinical trial information for NCT06408103 through Pure Global AI's free database. This phase not specified trial is sponsored by Universidad de Santander and is currently Not yet recruiting. The study focuses on Mild Cognitive Impairment. Target enrollment is 102 participants.

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NCT06408103
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Trial Details
ClinicalTrials.gov โ€ข NCT06408103
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Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad

Study Focus

Mild Cognitive Impairment

Multi-component, transdisciplinary and multifocal intervention for the cognition

Interventional

other

Sponsor & Location

Universidad de Santander

Timeline & Enrollment

N/A

May 15, 2024

Feb 28, 2025

102 participants

Primary Outcome

Change in global cognition,Change in global cognition,Change in verbal learning and memory,Change in processing speed and visual attention,Change in visual attention, thinking speed, and visuospatial ability,Change in executive functioning and selective attention,Change in perceptual organization and visual memory,Change in verbal fluency and executive functions,Change in comprehension and expression levels,change in verbal comprehension,Change WAIS III Digit Retention

Summary

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.

ICD-10 Classifications

Mild cognitive disorder
Alzheimer disease
Dementia in other specified diseases classified elsewhere
Dementia in other diseases classified elsewhere
Dementia in Alzheimer disease

Data Source

ClinicalTrials.gov

NCT06408103

Non-Device Trial