NCT06408103|RecruitingDMC
Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad
INTERCOG
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INTERCOG
Sponsor study identifier
interventional
102
1 country
1
Study Start
July 30, 2024
Actual (reported)Primary Completion
July 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 5, 2024
Actual (reported)May 9, 2024
Actual (reported)July 30, 2024
Actual (reported)July 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in global cognition
It will be evaluated by the Montreal Cognitive Assessment (MoCA). The scale evaluates 6 domains: visuospatial ability, executive function, memory, attention/concentration, language, and orientation. It has a scoring scale from 0 to 30, with the following interpretation: 26 or more: No cognitive impairment. 20 to 23: Mild Cognitive Impairment. Score less than 10: major neurocognitive disorder
3 months after the intervention, with follow-up at 6 and 9 months
Change in global cognition
It will be evaluated by Mini Mental State Examination (MMSE). The scale evaluates the dimensions of orientation, memory, attention and calculation, memory, and language. It has a score of 0 to 30 points and can be categorically interpreted as follows: between 30 and 27 points: No cognitive impairment. Between 26 and 25 points: Possible cognitive impairment. Between 24 and 10 points: mild to moderate cognitive impairment. Between 9 and 6 points: moderate to severe cognitive impairment. Less than 6 points: Major cognitive impairment.
3 months after the intervention, with follow-up at 6 and 9 months
Change in verbal learning and memory
The change in verbal learning and memory will be assessed using the Hopkins Verbal Learning Test (HVLT). It consists of 12 words grouped into three semantic categories. In the population aged between 56 and 76 years, the mean total recall is 18.6 with a standard deviation of 4.6, while for delayed recall, the mean is 6.1 with a standard deviation of 2.4
3 months after the intervention, with follow-up at 6 and 9 months
Change in patient independence
3 months after the intervention, with follow-up at 6 and 9 months
Change in physical frailty
3 months after the intervention, with follow-up at 6 and 9 months
Change in nutritional status
3 months after the intervention, with follow-up at 6 and 9 months
Change in mobility and balance
3 months after the intervention, with follow-up at 6 and 9 months
Changes in functional capacity and physical condition
3 months after the intervention, with follow-up at 6 and 9 months
Feasibility, acceptability, and adherence to the intervention
3 months
This group will receive a multi-component intervention that includes cognitive training, physical exercise, and nutritional counseling; dually and simultaneously. This intervention will be carried out at the patient's home for 12 weeks, with professional support twice a week plus a recommendation to walk 30 minutes/day. Furthermore, in the family component, caregivers of the patients will also receive a training component to accompany the intervention and prepare for the caregiver role. This component will be delivered by healthcare professionals in a group format (n=10 per group) over 12 weeks, with weekly sessions lasting 2 hours each. Each session is organized into five parts: opening, activation, education, practice, and explanation of the activities for the next week.
The conventional management of patients with mild cognitive impairment focuses on therapies such as cognitive rehabilitation, occupational therapy, and physical exercise, with medical monitoring as needed according to the patient's needs. Additionally, they will receive information about infectious diseases such as dengue, pneumonia, tuberculosis, Chagas disease, leishmaniasis, COVID-19, leprosy, urinary tract infection, rabies, superficial and cutaneous mycoses, and hepatitis one topic per week through an infographic and video sent to the cell phone.
Multi-component intervention (12 weeks, twice/week, with professional support at home) Physical activity for the patient: dual training, strength, balance, with intensity increase monthly, plus moderate walking of 30 minutes/day, 5 days per week. Nutritional advice for the patient: Month 1- reduction of added sugars and processed carbohydrates. Month 2- increase consumption of healthy fats and reduction of saturated fats; Month 3- increase in consumption of fruits and vegetables, and a monthly group practical workshop. Cognitive training for the patient: activities focused on orientation, attention and concentration, working memory, mathematical reasoning, language, visual construction, executive functions, and reminiscence therapy. Accompaniment for the family member: Activities aimed at care and self-care, understanding cognitive deterioration and its progression, support for patient adherence to the intervention, and activities in groups once a week.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Universidad de Santander / Universidad Manuela Beltrán /FOSCAL
Bucaramanga, Santander Department, 62215, Colombia
Tiga-Loza DC, Alvarez-Anaya WA, Rivera-Carvajal R, Ardila AC, Buitrago-Buitrago JA, Pabon A, Castaneda-Hernandez A, Reyes-Pulido MM, Guzman KP, Salazar HUA, Urrea-Vega EA, Carreno-Parra LM, Camacho PA. Nonpharmacological multicomponent intervention for mild cognitive impairment with a family-patient approach: protocol for the pilot clinical trial-INTERCOG study. Pilot Feasibility Stud. 2026 Jun 27;12(1):127. doi: 10.1186/s40814-026-01871-1.
Diana Tiga Loza
Universidad de Santander
First Submitted
April 5, 2024
First Posted
May 9, 2024
Study Start
July 30, 2024
Actual (reported)Change in processing speed and visual attention
The change in processing speed and visual attention will be evaluated using the Symbol Digit Modalities Test (SDMT). This test assesses two domains: processing speed and sustained attention. In the population aged between 56 and 76 years, the mean score is 27 (12.1)
3 months after the intervention, with follow-up at 6 and 9 months
Change in visual attention, thinking speed, and visuospatial ability
The change in visual attention, thinking speed, and visuospatial ability will be evaluated using the Trail Making Test (TMT-Form A, TMT-Form B). Interpreting the results involves comparing completion times of these forms with normative data corresponding to the same age group. For context, the mean completion times for TMT-A and TMT-B in the population aged 56 to 75 years are as follows: 75.8 seconds (with a standard deviation of 22.8 seconds) for TMT-A and 178 seconds (with a standard deviation of 80.7 seconds) for TMT-B.
3 months after the intervention, with follow-up at 6 and 9 months
Change in executive functioning and selective attention
The Color and Word Test assesses executive functioning and selective attention, measuring processing speed and the ability to focus on relevant stimuli while discarding distractors. It also examines cognitive control, inhibition and resistance to cognitive interference. The mean scores for 'Word', 'Color', 'Word-Color' and 'Interference' are 77.7 (standard deviation 21.8), 55.5 (standard deviation 16.6), 30.8 (standard deviation 11.6) and -1.4 (standard deviation 9.1) respectively, reflecting the cognitive abilities of the tested group.
3 months after the intervention, with follow-up at 6 and 9 months
Change in perceptual organization and visual memory
The change in perceptual organization and visual memory will be assessed through the Rey Complex Figure Test. This test is divided into 18 elements, each of which scores 2 if the execution is correct; if there is a mistake in the placement or tracing of the element, 1 point is awarded, and if both the placement and tracing are incorrect (or the element is absent), 0 points are awarded. Thus, the total possible score varies between 0 and 36. Two sets of scores are obtained: one for immediate copy and another for long-term recall. In the age group of 56 to 76 years, the mean score for the copying task is 27.9 with a standard deviation of 7.4, while for long-term memory, the mean is 13.7, also with a standard deviation of 7.4
3 months after the intervention, with follow-up at 6 and 9 months
Change in verbal fluency and executive functions
Change in verbal fluency and executive functions will be assessed through the Semantic and Phonological Verbal Fluency Test. This test evaluates the ability to generate words following specific semantic or phonological criteria. Scores are assigned based on semantic category and the initial letter of words. For the letter "F," the mean is 9.9 with a standard deviation of 4.3; for "A," the mean is 10.1 with a standard deviation of 4.4; and for "S," the mean is 9.6 with a standard deviation of 4.4. In semantic categories, "ANIMALS" has a mean of 15.6 with a standard deviation of 4.5, while "FRUITS" has a mean of 13 with a standard deviation of 3.7. These scores reflect the quantity and variety of words individuals can produce and are indicative of their linguistic ability and executive capacity
3 months after the intervention, with follow-up at 6 and 9 months
Change in comprehension and expression levels
The change in the levels of verbal naming and expression will be assessed from the BOSTON Naming Test. In the age group 56 to 76 years, the mean score for the copying task is 42.8 with a standard deviation of 8
3 months after the intervention, with follow-up at 6 and 9 months
change in verbal comprehension
TThe Token Test will be used to assess verbal comprehension. This test specifically measures skills related to listening comprehension and the ability to follow instructions. As for the cut-off points for the different ages, they are set as follows: 50 to 56 years (31.5-32), 57 to 59 years (32-32.5), 60 to 68 years (32-32.5), 69 to 71 years (31-31.5), 72 to 74 years (31.5-32.5).
3 months after the intervention, with follow-up at 6 and 9 months
Change WAIS III Digit Retention
It is designed to evaluate attention and working memory. It consists of a total of 8 items distributed in two trials. This task is divided into two parts: one that requires repeating the numbers in the order in which they are presented (direct order) and another in the reverse order. For individuals between 50 and 71 years of age, the cut-off points for correct retention are 4 in the direct order and 3 in the reverse order. These thresholds indicate the minimum number of digits that the individual must remember correctly to be considered within a normal range of functioning in each task modality
3 months after the intervention, with follow-up at 6 and 9 months
Contact the study team to confirm eligibility.
Primary Completion
July 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 7, 2026
Record last verified: 2026-04
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