Home › Research › Mild cognitive impairment
Nonpharmacological multicomponent intervention for mild cognitive impairment with a family-patient approach: protocol for the pilot clinical trial—INTERCOG study
Diana Carolina Tiga-Loza, William Armando Álvarez Anaya, Raquel Rivera-Carvajal, Ariel Calderón Ardila, Jhosman Alfonso Buitrago Buitrago, Alexander Pabón, Álvaro Castañeda-Hernández, Mabel Margoth Reyes-Pulido et al.. PubMed Central, 2026-06-01
Topic: Risk, prevention and care in population studies
Abstract Background Given the risk of progression to dementia ranging from 6 to 44.8% over approximately 4 years of follow-up, nonpharmacological multicomponent interventions are emerging as promising strategies to improve or maintain cognitive function and quality of life in individuals with mild cognitive impairment (MCI). This pilot study aims to evaluate the feasibility and potential efficacy of a multicomponent and transdisciplinary intervention focused on the dyad of older adults with MCI–family study partner to promote cognitive function in older adults. Methods A pilot, randomized, controlled, and double-blind clinical trial will be conducted with 102 dyads consisting of an older adult with MCI and their family study partner. The participants will be randomly assigned to two groups: the intervention group (INTERCOG) and the control group. The INTERCOG group will receive a 12-week home-based intervention (twice weekly) with the support of a healthcare professional. The intervention components consist of cognitive training and stimulation, nutritional counseling, and physical exercises. Simultaneously, family members will participate in a training program on care and self-care. The control group will receive an Enhanced Standard of Care with educational messages on infection prevention. The feasibility of the study will be assessed through an analysis of recruitment, data collection, intervention acceptability, and implementation challenges; also, changes in global cognition and changes in specific cognitive domains will be measured as exploratory results. Secondary outcomes will include changes in health-related quality of life, caregiver burden, social support for family members, as well as changes in functional independence, frailty, physical capacity, family functioning, and nutritional status in patients, with follow-up at 3, 6, and 9 months. In a subsample of 40 participants, the diversity of the gut microbiota will be characterized, and the frequency of the APOE-ε4 allele will be determined. Discussion Multicomponent and transdisciplinary interventions focused on the family member–patient dyad have the potential to optimize cognitive outcomes and quality of life. This pilot study will allow us to identify key aspects of the feasibility and potential efficacy of INTERCOG intervention, crucial information for the design of future larger-scale studies. Trial registration NCT06408103. December 6, 2024, at clinicaltrials.gov. In recruitment.
Key findings
- The feasibility of the study will be assessed through an analysis of recruitment, data collection, intervention acceptability, and implementation challenges; also, changes in global cognition and changes in specific cognitive domains will be measured as exploratory results.
Why it matters
This is a protocol for a pilot randomized controlled trial testing a 12-week home-based multicomponent intervention of cognitive training, nutritional counseling, and physical exercise for older adults with mild cognitive impairment and their family study partners. It has not yet shown whether the intervention works, so it cannot yet say anything about treating, curing, or preventing Alzheimer's disease.
Study details
- Participants40
- Effect size44.8%
- Evidence strengthHigh
How this study scored 43/100
Published in a peer-reviewed journal. Scored zero for study design because the record does not state it. We have no data on journal's citation record, so that was left out: it earned 41 of the 96 points we could judge it on, which is 43 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (PubMed Central) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 5 / 5 | 2026 — within 1 year(s) of the newest study here |
| Sample size | 1 / 4 | 40 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 1 / 2 | Randomised (as stated in the record) |
| Times cited | 0 / 7 | Cited 0 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.0 citations a year over 2 year(s) since 2026 |
| Impact for its field and year | 0 / 6 | Cited 0.0× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 0 / 4 | Cited 0 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Paul Anthony Camacho: h-index 35 (OpenAlex, whole career) |
| Institution's track record | 0 / 3 | Universidad De Santander: institution h-index 122 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 5 institution(s) in 1 country |
| Indexed in PubMed | 1 / 2 | Not in PubMed, but has a DOI |
| Free to read | 2 / 2 | Free to read |
| Points | 41 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 41 of the 96 points we could judge it on is 43 out of 100. |
| Total | 43 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
APA 7th
Tiga-Loza, D. C., Anaya, W. A. Á., Rivera-Carvajal, R., Ardila, A. C., Buitrago, J. A. B., Pabón, A., et al. (2026). Nonpharmacological multicomponent intervention for mild cognitive impairment with a family-patient approach: protocol for the pilot clinical trial—INTERCOG study. PubMed Central. https://doi.org/10.1186/s40814-026-01871-1
Vancouver
Tiga-Loza DC, Anaya WAÁ, Rivera-Carvajal R, Ardila AC, Buitrago JAB, Pabón A, et al. Nonpharmacological multicomponent intervention for mild cognitive impairment with a family-patient approach: protocol for the pilot clinical trial—INTERCOG study. PubMed Central. 2026. doi:10.1186/s40814-026-01871-1.
BibTeX
@article{tigaloza2026-12e6dfb4,
author = {Tiga-Loza, Diana Carolina and Anaya, William Armando Álvarez and Rivera-Carvajal, Raquel and Ardila, Ariel Calderón and Buitrago, Jhosman Alfonso Buitrago and Pabón, Alexander and Castañeda-Hernández, Álvaro and Reyes-Pulido, Mabel Margoth and others},
title = {{Nonpharmacological multicomponent intervention for mild cognitive impairment with a family-patient approach: protocol for the pilot clinical trial—INTERCOG study}},
journal = {PubMed Central},
year = {2026},
doi = {10.1186/s40814-026-01871-1},
url = {https://doi.org/10.1186/s40814-026-01871-1}
}