Mild Cognitive ImpairmentINTERCOGNCT06408103
Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad
A study testing Multi-component, transdisciplinary and multifocal intervention for the cognition in people with Mild Cognitive Impairment, run by Universidad de Santander at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Multi-component, transdisciplinary and multifocal intervention for the cognition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteColombia
- Study dates
- 30 Jul 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 55 years or older.
- Diagnosis of mild cognitive impairment by a Psychiatrist/Neurologist supported by neuropsychological evaluation.
- Functionality for instrumental activities.
- Basic proficiency in reading and writing.
- Absence of untreated hearing impairment and/or uncorrected visual problems.
- Availability of a primary family caregiver (to be identified).
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- IPAQ with low level of physical activity (pending cutoff point), PARQ and you Fit (pending review).
- Barthel Index equal to or greater than 80 points.
- Functional capacity for short-distance ambulation without permanent use of mechanical aids such as wheelchairs.
- Individuals with a BMI greater than 18.5.
- Gastrointestinal tract without surgical resections.
- Tolerance to oral feeding.
- Vaccination against COVID-19.
- Adults aged 18 years or older.
- Basic proficiency in reading and writing.
- Having a level of kinship (consanguineous or non-consanguineous).
- Vaccination against COVID-19.
Who cannot join
- History of psychosis or congenital intellectual disability.
- Presence of a central nervous system pathology that could affect cognition (Parkinson's disease, tumors, encephalitis, epilepsy, cerebrovascular disease, traumatic brain injury).
- Presence of untreated psychiatric disorders, anxiety, depression (Yesavage).
- 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.
- Older adult with Chronic Kidney Disease, Hepatopathies (hepatitis, liver cirrhosis),
- Pulmonary Diseases, or requiring oxygen support, Crohn's Disease, and Colitis.
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- Individual with oncological pathology who has received or is receiving chemotherapy.
- Individual who has received probiotics or prebiotics in the last 30 days.
- Presence of clinically significant, active infectious etiology diarrhea.
- Current or prior abuse of alcohol, tobacco, or drugs.
- Use of steroids or immunosuppressants in the last 30 days.
- Recent use of antibiotics, antifungals, or antivirals (excluding topicals) in the last 3 months.
- Individual who voluntarily decides to withdraw from the study.
- Older adult without oral, enteral, or parenteral nutritional support.
- Poor tolerance to exercise, vertigo, medical exercise restriction.
- Elimination criteria
- Institutionalized or hospitalized for more than 1 week, or death during the intervention phase (review and clarity on death).
- Failure to attend more than 34% of sessions with professional accompaniment (applies to the dyad).
- Inclusion and exclusion criteria for caregivers ( Family members)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Universidad de Santander / Universidad Manuela Beltrán /FOSCAL
Bucaramanga, Santander Department, 62215
William A Alvarez, +573204786018, investigaciones.bga@umb.edu.co
Raquel Rivera Carvajal, +573138196059, raq.rivera@mail.udes.edu.co
About this study
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.
Read the detailed description
Introduction: The aging of the population has led to an increase in the number of individuals with cognitive impairment and neurodegenerative diseases, resulting in greater disability and dependence among older adults worldwide. The prevalence of Mild Cognitive Impairment (MCI) is estimated to be approximately 16%, varying between 2% and 31%.
Multiple interventions have been tested to maintain or improve cognitive function in older adults, including cognitive-motor interventions, yoga, psychosocial and lifestyle interventions, as well as arts-based interventions (dance, theater, music, or visual arts). However, the literature indicates that multicomponent interventions (MCI), also known as multimodal or multidomain, are more effective compared to single-domain interventions in improving cognitive function in older adults.
General Objective: To evaluate the efficacy of a multicomponent intervention focusing on cognitive function for the caregiver-patient dyad
Methods: Pilot randomized clinical trial, with 1:1 allocation in 102 patients with mild cognitive impairment and their primary caregivers/family members.
Results: The goal is to generate evidence on the efficacy and applicability of these interventions to create a care guide for the caregiver-patient dyad with cognitive impairment, tailored to the Colombian population, with the involvement of different institutions such as universities and healthcare providers.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Multi-component, transdisciplinary and multifocal intervention for the cognition
- Keywords
- Rehabilitation, Informal caregiver, Transdisciplinary intervention, Multi-component intervention, Cognitive dysfunction
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component, transdisciplinary and multifocal intervention for the cognitionOther
Also called INTERCOG
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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-component, transdisciplinary and multifocal intervention (intercog-group) | Experimental | 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. Receives: Other: Multi-component, transdisciplinary and multifocal intervention for the cognition |
| Usual care plus active control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 3 months after the intervention, with follow-up at 6 and 9 months
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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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
Measured: 3 months after the intervention, with follow-up at 6 and 9 months
Secondary outcomes (9)
Change in patient independence
The patient's independence will be assessed using the Lawton and Brody scale. This scale evaluates functional capacity with 8 items: "ability to use the telephone, shop, prepare food, take care of the house, wash clothes, use transportation, and responsibility regarding medication and administration of their finances." Each item is rated between 0 (dependent) and 1 (independent), and the total score ranges from 0 to 8, reflecting the time required to perform these activities.
Measured: 3 months after the intervention, with follow-up at 6 and 9 months
Change in physical frailty
It will be evaluated using the Linda Fried Frailty Scale, four criteria will be taken: poor physical activity, self-report of physical fatigue, unintentional weight loss, and muscle weakness (estimated by grip strength). The results are interpreted as follows: No criteria = robust, 1 or 2 criteria = pre-frail, 3 or more criteria = frail
Measured: 3 months after the intervention, with follow-up at 6 and 9 months
Change in nutritional status
The nutritional status will be assessed through the Mini Nutritional Assessment (MNA) scale. This scale includes six items: loss of appetite, recent weight loss, mobility, presence of acute illness or psychological stress in the last three months, presence of neuropsychological problems, and body mass index. A score between 12-14 points indicates normal nutritional status, 8-11 points signify a risk of malnutrition, and 0-7 points indicate malnutrition. For a more detailed assessment, three additional items will be evaluated, including whether the patient lives independently, takes more than 3 medications per day, and has skin injuries, through a dichotomous scale of Yes or No
Measured: 3 months after the intervention, with follow-up at 6 and 9 months
Change in mobility and balance
It will be evaluated with the Tinetti Scale. This scale consists of 2 dimensions: mobility and balance, distributed in 9 items. A score of less than 19 points in both dimensions will imply a high risk of falls, a score of 19 to 24 will reflect a medium risk of falls and a score of 25 to 28 will indicate a low risk of falls
Measured: 3 months after the intervention, with follow-up at 6 and 9 months
Changes in functional capacity and physical condition
The assessment will be conducted using the Senior Fitness Test, which consists of six tests grouped into five categories: muscular strength, flexibility, aerobic capacity, agility, and balance.
Muscular strength is evaluated with two tests: the chair stand test and the arm curl test. Flexibility is assessed using the chair sit-and-reach test and the back scratch test. Aerobic capacity can be evaluated with either the 6-minute walk test or the 2-minute step test. Agility and balance are assessed with the up-and-go test.
The test scores depend on the participant's gender and age.
Measured: 3 months after the intervention, with follow-up at 6 and 9 months
Change in the composition of the microbiome
Changes in bacterial communities and their metabolites will be assessed using 16S rRNA sequencing for microbiota analysis and both targeted and non-targeted metabolomic approaches for metabolite profiling in blood and stool samples, using mass spectrometry as an analytical technique. This test will be performed on a random sample of patients.
Measured: 3 months after the intervention
Change in family caregiver overload
The caregiver overload is assessed through the Zarit Burden Interview-ZBI, which analyzes the subjective experience of the burden perceived by the caregiver. The scale includes 22 items, scored on a Likert scale of frequency ranging from 1 to 5 points. The total score on the scale can range from 22 to 110 points, with the following categorization: < 46 points: No overload, 46 to 56 points: Mild overload, 57 or more points: Intense overload.
Measured: 3 months after the intervention, with follow-up at 6 and 9 months
Change in Social Support for Family Caregiver
Social support will be determined using the Medical outcomes study social support survey (MOS-SSS). This instrument includes 20 items organized into 4 dimensions: Emotional support, instrumental support, positive social interaction, and affective support. It utilizes a 5-point Likert scale. All items are rated on a 5-point Likert frequency scale. The total score for the global social support index can range from 19 to 95 points, with the following categories: Maximum 95 points, medium 57 points, and minimum 19 points. Low overall social support: <57 points.
Measured: 3 months after the intervention, with follow-up at 6 and 9 months
Change in quality of life in the dyad
Quality of life will be measured through the SF-36 questionnaire applied to the dyad. It consists of 36 questions, in 8 dimensions: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health of the patient. The score is transformed into a scale with a range from 0 (worst health status) to 100 (best health status) and a summary calculation of two dimensions (physical and mental) using the weighted sum of the scores of the eight dimensions.
Measured: 3 months after the intervention, with follow-up at 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start30 Jul 2024
- Primary completion28 Jul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Santander
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Manuela Beltrán, Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle, Universidad Autónoma de Bucaramanga, Universidad Santo Tomas, Ministry of Science, Technology, and Innovation, Minciencias
- Responsible party
- Principal investigator, Diana Carolina Tiga, Phd, Universidad de Santander
- Investigators
- Diana Tiga Loza, Study director, Universidad de Santander
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408103
- Sponsor's protocol ID
- CTO 652-21
- Acronym
- INTERCOG
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 42365385
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad
- ClinicalTrials.gov ID
- NCT06408103
- Acronym / sponsor ID
- INTERCOG / CTO 652-21
- Conditions
- Mild Cognitive Impairment
- Keywords
- Rehabilitation, Informal caregiver, Transdisciplinary intervention, Multi-component intervention, Cognitive dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Universidad de SantanderUniversity, hospital or other
- Collaborators
- Universidad Manuela Beltrán, Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle, Universidad Autónoma de Bucaramanga, Universidad Santo Tomas, Ministry of Science, Technology, and Innovation, Minciencias
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 28 Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: The aging of the population has led to an increase in the number of individuals with cognitive impairment and neurodegenerative diseases, resulting in greater disability and dependence among older adults worldwide. The prevalence of Mild Cognitive Impairment (MCI) is estimated to be approximately 16%, varying between 2% and 31%.
Multiple interventions have been tested to maintain or improve cognitive function in older adults, including cognitive-motor interventions, yoga, psychosocial and lifestyle interventions, as well as arts-based interventions (dance, theater, music, or visual arts). However, the literature indicates that multicomponent interventions (MCI), also known as multimodal or multidomain, are more effective compared to single-domain interventions in improving cognitive function in older adults.
General Objective: To evaluate the efficacy of a multicomponent intervention focusing on cognitive function for the caregiver-patient dyad
Methods: Pilot randomized clinical trial, with 1:1 allocation in 102 patients with mild cognitive impairment and their primary caregivers/family members.
Results: The goal is to generate evidence on the efficacy and applicability of these interventions to create a care guide for the caregiver-patient dyad with cognitive impairment, tailored to the Colombian population, with the involvement of different institutions such as universities and healthcare providers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-component, transdisciplinary and multifocal intervention (intercog-group) | Experimental | Other: Multi-component, transdisciplinary and multifocal intervention for the cognitionThis 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. |
| Usual care plus active control | No intervention | –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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age of 55 years or older.
- Diagnosis of mild cognitive impairment by a Psychiatrist/Neurologist supported by neuropsychological evaluation.
- Functionality for instrumental activities.
- Basic proficiency in reading and writing.
- Absence of untreated hearing impairment and/or uncorrected visual problems.
Key exclusion criteria (19 listed)
- History of psychosis or congenital intellectual disability.
- Presence of a central nervous system pathology that could affect cognition (Parkinson's disease, tumors, encephalitis, epilepsy, cerebrovascular disease, traumatic brain injury).
- Presence of untreated psychiatric disorders, anxiety, depression (Yesavage).
- 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.
- Older adult with Chronic Kidney Disease, Hepatopathies (hepatitis, liver cirrhosis),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-component, transdisciplinary and multifocal intervention for the cognitionAlso: INTERCOGMulti-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. | Other | Multi-component, transdisciplinary and multifocal intervention (intercog-group) |
Primary outcome
Change in global cognition
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
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
Change in global cognition
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
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.
Change in verbal learning and memory
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
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
Change in processing speed and visual attention
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
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)
Change in visual attention, thinking speed, and visuospatial ability
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
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.
Change in executive functioning and selective attention
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
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.
Change in perceptual organization and visual memory
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
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
Change in verbal fluency and executive functions
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
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
Change in comprehension and expression levels
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
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
change in verbal comprehension
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
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).
Change WAIS III Digit Retention
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
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
9 secondary outcomes
Change in patient independence
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
Change in physical frailty
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
Change in nutritional status
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
Change in mobility and balance
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
Changes in functional capacity and physical condition
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
Change in the composition of the microbiome
Time frame: 3 months after the intervention
Change in family caregiver overload
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
Change in Social Support for Family Caregiver
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
Change in quality of life in the dyad
Time frame: 3 months after the intervention, with follow-up at 6 and 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Derived from this study: PubMed 42365385Tiga-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diana Tiga Loza study director
Universidad de Santander
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component, transdisciplinary and multifocal intervention for the cognition in people with Mild Cognitive Impairment, run by Universidad de Santander at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Tiga Loza, Ph.D (+57 (607) 6516500, dia.tiga@mail.udes.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global cognition (time frame: 3 months after the intervention, with follow-up at 6 and 9 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06408103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.