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New study aims to slow memory decline with caregiver support

NCT ID NCT06408103

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a 12-week program for people with mild cognitive impairment (early memory loss) and their main family caregiver. The program includes professional-led sessions and caregiver support to improve thinking, memory, and quality of life for both. Researchers will track changes in cognitive function, independence, and caregiver burden over 9 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 102 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Universidad de Santander / Universidad Manuela Beltrán /FOSCAL

    RECRUITING

    Bucaramanga, Santander Department, 62215, Colombia

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