Mild Cognitive ImpairmentNCT06279325
Effects of a Computerized Cognitive Stimulation Intervention Adapted to the Level of Cognitive Reserve
A study testing Computerized cognitive stimulation program and Face-to-face training-explanatory session in people with Mild Cognitive Impairment and Cognitive Dysfunction, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Normal ageing presents subtle cognitive changes that can be detected before meeting the criteria for Mild cognitive impairment (MCI). Older people with low cognitive reserve and who receive limited cognitive stimulation are at greater risk of deterioration. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Cognitive Dysfunction
- What is being tested?
- Computerized cognitive stimulation program and Face-to-face training-explanatory session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2024to 15 Jan 2025
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: ≥ 60 years.
- With score in Lobo's Mini-cognitive Examination (MEC-35) (Lobo, A., Escolar, V., Ezquerra, J., \& Seva Díaz, 1979) between: 28-35 points (Friedman et al., 2012; Vinyoles Bargalló et al., 2002).
- Non-institutionalized persons, belonging to the health centers where the study was conducted.
- With a minimum educational level (knowing how to read and write).
- Who do not present hearing, visual or communication difficulties that would prevent them from completing the cognitive training.
Who cannot join
- People with mild cognitive impairment or Alzheimer's disease (AD).
- People with significant functional impairment.
- People who have received any type of professionalized cognitive stimulation therapy in the last year.
- People with significant psychiatric conditions, such as major depressive disorder or schizophrenia.
- People who are taking medications that may adversely affect cognitive function, such as anticholinergics, tranquilizers and anticonvulsants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Centro de Salud Arrabal
Zaragoza, Zaragoza, 50015
Rosa Magallón Botaya, +34 622 71 97 59, gaiap.contacto@gmail.com
About this study
Official title: Analysis of the Effectiveness of a Computerized Cognitive Stimulation Program Designed from Occupational Therapy According to the Level of Cognitive Reserve in Older Adults in Primary Care: Stratified Randomized Clinical Trial Protocol
Normal ageing presents subtle cognitive changes that can be detected before meeting the criteria for Mild cognitive impairment (MCI). Older people with low cognitive reserve and who receive limited cognitive stimulation are at greater risk of deterioration. In this regard, cognitive stimulation (CS) has been identified as an intervention that reduces this risk, provided that its design considers the differences in the level of cognitive reserve (CR) acquired throughout life and the baseline level of cognitive functioning. The general objective of this study is to evaluate, through a randomized clinical trial, the effectiveness of a computerized cognitive stimulation program, designed and adapted from Occupational Therapy based on the level of cognitive reserve in older adults in Primary Care. 100 participants will be randomized in a stratified manner according to the level of cognitive reserve (high/low), assigning 50 participants to the control group and 50 participants to the intervention group. The intervention group will carry out a computerized cognitive stimulation intervention designed and adapted from occupational therapy according to the level of cognitive reserve, through the "stimulus" platform. The main result expected to be achieved is the improvement of higher brain functions. As secondary results, the investigators expect that those cognitive aspects most vulnerable to ageing will decrease more slowly (in areas such as memory, executive function, attention and processing speed) and that the cognitive reserve of the participants will increase, in addition to being able to balance gender differences in these aspects. The investigators think that these results can positively impact the creation of adapted, meaningful and stimulating CS programs in older adults to prevent MCI and experience healthier ageing.
- Conditions
- Mild Cognitive Impairment, Cognitive Dysfunction
- Being tested
- Computerized cognitive stimulation program, Face-to-face training-explanatory session
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive stimulation programBehavioural
- The cognitive stimulation (CS) program, for the IG, will be previously designed by 2 Occupational Therapy (OT) of the team, and adapted to the computerized format through a platform specialized in cognitive neurorehabilitation. The activities will be designed under OT models: human occupation model and cognitive-perceptual model, so that the different professions, interests and roles are represented, and allow to express different levels of complexity, according to the level of Cognitive Reserve (CR).
- The cognitive aspects to be worked on are: memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention-concentration and executive functions.
- In addition, reinforcement, EF, episodic memory, attention and information processing speed activities will be designed, also according to the CR level.
Face-to-face training-explanatory sessionBehavioural
The CG will undergo a group and face-to-face training-explanatory session, where the importance of maintaining the usual level of cognitive activity will be emphasized.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Stimulation program | Experimental | Not described Receives: Behavioral: Computerized cognitive stimulation program |
| Control Group | Active comparator | Not described Receives: Behavioral: Face-to-face training-explanatory session |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEC-35 (Spanish version of Folstein's Mini-Mental)
The primary outcome variable is MEC-35 (Spanish version of Folstein's Mini-Mental): the most widely used cognitive test in Primary Care, adapted by Lobo to the Spanish population (Lobo, A., et al 1979). It evaluates 8 components: temporal orientation, spatial orientation, fixation memory, attention, calculation, short-term memory, language and praxis. Its sensitivity is 85-90% and its specificity 69% (Lobo, A. et al 1999). Although its cut-off point for detecting cognitive impairment is 24, in NC, scores between 28-35 points are considered (Friedman et al., 2012; Vinyoles Bargalló et al., 2002).
Measured: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
Cognitive Reserve Questionnaire (CRQ)
To determine the level of cognitive reserve (Landenberger et al., 2019) the most suitable questionnaire is the Cognitive Reserve Questionnaire (CRQ) (Rami et al., 2011). It has eight items with between three and six response options. Each item relieves a CR factor: schooling, parental schooling, courses, occupation, musical training, languages, reading and intellectual games. The maximum score is 25 points. Between 7 and 9 points is considered a medium-low range of CR. Between 10-14 points medium-high range, and ≥15 points, high CR. It is an instrument with high reliability and acceptable convergent validity (Martino et al., 2021).
Measured: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
Secondary outcomes (5)
Set-Test
-Set-Test (Pascual, L., Martinez, J., Modrego, P., Mostacero, E., Lopez del Val, J., \& Morales, 1990): measures verbal fluency of categorical type: colors, animals, fruits and cities, asking the patient to say elements of the 4 categories in one minute. It presents a sensitivity of 87% and a specificity of 67%.
Measured: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
The SDMT or Symbols and Digits Test
The SDMT or Symbols and Digits Test measures EF, processing speed and attention. It is a test with good accuracy, sensitivity and specificity, useful for predicting future MCI. The SDMT card consists of a header with a key that relates the numbers from 1 to 9 with different symbols; the participant has 90 seconds to match a specific number with a particular geometric figure. The response can be written or verbal, and the maximum total response time is five minutes. The ideal cut-off point is 44 points, although 38 points can be used for a more specific result (Baudouin et al., 2009).
Measured: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
Color Word Stroop Test (CWST)
Color Word Stroop Test (CWST) (Cheng et al., 2012) assesses perseveration, cognitive flexibility, EF and attention (Uttl \& Graf, 1997). It consists of naming a color with and without the presence of conflicting or incongruent stimuli. The test consists of three sheets: in the first one, colors written in black ink are repeated, in the second one colors with their geometric figure, and in the third one colors written in different ink. The correct answers in the three sheets are collected. This test shows a decrease by age and gender (the most impaired EF in men) (Periáñez et al., 2021; Van der Elst et al., 2008). The limits considered normal are 35-65 points (Graf et al., 1995).
Measured: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
Verbal Learning Test (TAVEC)
Verbal Learning Test (TAVEC) Spanish version of the California Verbal Learning Test (CVLT). It evaluates learning and episodic memory capacity. The test consists of memorizing a list of 16 words (list A), belonging to four semantic categories, and their subsequent recall. Five trials are repeated and a second list of 16 words (list B) is administered. Subsequently, recall of list A and recall by semantic categories is requested. After about 20 minutes, free recall of word list A and recall by semantic categories is requested again. Both Spearman's coefficient and Cronbach's α indicate high reliability (Nieto Barco et al., 2014).
Measured: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
Mobile Device Proficiency Questionnaire in Short Form (MDPQ-16)
Mobile Device Proficiency Questionnaire in Short Form (MDPQ-16). Tests experience and aptitude for using mobile devices in eight domains: mobile device basics, communication, data and file storage, Internet, calendar, entertainment, privacy, troubleshooting, and software management. Each of the domains is scored on a 5-point scale (e.g., 1 = never tried , 2 = not at all , 3 = not very easily , 4 = somewhat easily , 5 = very easily). The total score ranges from 8 to 40, with higher scores reflecting greater competence. Internal consistency is excellent (Cronbach's α=.96).(Roque \& Boot, 2018).
Measured: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Apr 2024
- Primary completion31 May 2024
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Estela Calatayud, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279325
- Sponsor's protocol ID
- C.I. PI23/637
- Status last verified
- Dec 2024
- First submitted
- 14 Feb 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The primary objective of this plan is to disseminate individual participant data (IPD) from our research study to a wide audience of researchers and stakeholders. By publishing in open-access journals and presenting at conferences, the investigators aim to maximize the visibility and accessibility of our data, fostering collaboration and advancing scientific knowledge in our field.
Publications
Calatayud E, Olivan-Blazquez B, Aguilar-Latorre A, Cuenca-Zaldivar JN, Magallon-Botaya RM, Gomez-Soria I. Post-intervention effectiveness of a computerized personalized cognitive stimulation program adapted according to cognitive reserve in older adults without cognitive impairment in Primary Care: A randomized clinical trial. Arch Gerontol Geriatr. 2026 Nov;150:106348. doi: 10.1016/j.archger.2026.106348. Epub 2026 Jun 27.
PubMed 42400967Calatayud E, Olivan-Blazquez B, Aguilar-Latorre A, Cuenca-Zaldivar JN, Magallon-Botaya RM, Gomez-Soria I. Digital Competence and Cognitive Reserve in Relation to Different Domains of Cognitive Functioning in Older Adults and Factors Modulating This Association: A Cross-Sectional Study of a Randomized Clinical Trial. Geriatr Gerontol Int. 2025 Nov;25(11):1525-1535. doi: 10.1111/ggi.70199. Epub 2025 Oct 8.
PubMed 41060253
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effectiveness of a Computerized Cognitive Stimulation Program Designed from Occupational Therapy According to the Level of Cognitive Reserve in Older Adults in Primary Care: Stratified Randomized Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT06279325
- Acronym / sponsor ID
- C.I. PI23/637
- Conditions
- Mild Cognitive Impairment, Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 28 Feb 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.
Normal ageing presents subtle cognitive changes that can be detected before meeting the criteria for Mild cognitive impairment (MCI). Older people with low cognitive reserve and who receive limited cognitive stimulation are at greater risk of deterioration. In this regard, cognitive stimulation (CS) has been identified as an intervention that reduces this risk, provided that its design considers the differences in the level of cognitive reserve (CR) acquired throughout life and the baseline level of cognitive functioning. The general objective of this study is to evaluate, through a randomized clinical trial, the effectiveness of a computerized cognitive stimulation program, designed and adapted from Occupational Therapy based on the level of cognitive reserve in older adults in Primary Care. 100 participants will be randomized in a stratified manner according to the level of cognitive reserve (high/low), assigning 50 participants to the control group and 50 participants to the intervention group. The intervention group will carry out a computerized cognitive stimulation intervention designed and adapted from occupational therapy according to the level of cognitive reserve, through the "stimulus" platform. The main result expected to be achieved is the improvement of higher brain functions. As secondary results, the investigators expect that those cognitive aspects most vulnerable to ageing will decrease more slowly (in areas such as memory, executive function, attention and processing speed) and that the cognitive reserve of the participants will increase, in addition to being able to balance gender differences in these aspects. The investigators think that these results can positively impact the creation of adapted, meaningful and stimulating CS programs in older adults to prevent MCI and experience healthier ageing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Stimulation program | Experimental | Behavioral: Computerized cognitive stimulation program |
| Control Group | Active comparator | Behavioral: Face-to-face training-explanatory session |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: ≥ 60 years.
- With score in Lobo's Mini-cognitive Examination (MEC-35) (Lobo, A., Escolar, V., Ezquerra, J., \& Seva Díaz, 1979) between: 28-35 points (Friedman et al., 2012; Vinyoles Bargalló et al., 2002).
- Non-institutionalized persons, belonging to the health centers where the study was conducted.
- With a minimum educational level (knowing how to read and write).
- Who do not present hearing, visual or communication difficulties that would prevent them from completing the cognitive training.
Key exclusion criteria (5 listed)
- People with mild cognitive impairment or Alzheimer's disease (AD).
- People with significant functional impairment.
- People who have received any type of professionalized cognitive stimulation therapy in the last year.
- People with significant psychiatric conditions, such as major depressive disorder or schizophrenia.
- People who are taking medications that may adversely affect cognitive function, such as anticholinergics, tranquilizers and anticonvulsants.
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 |
|---|---|---|
| Computerized cognitive stimulation program* The cognitive stimulation (CS) program, for the IG, will be previously designed by 2 Occupational Therapy (OT) of the team, and adapted to the computerized format through a platform specialized in cognitive neurorehabilitation. The activities will be designed under OT models: human occupation model and cognitive-perceptual model, so that the different professions, interests and roles are represented, and allow to express different levels of complexity, according to the level of Cognitive Reserve (CR). * The cognitive aspects to be worked on are: memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention-concentration and executive functions. * In addition, reinforcement, EF, episodic memory, attention and information processing speed activities will be designed, also according to the CR level. | Behavioural | Cognitive Stimulation program |
| Face-to-face training-explanatory sessionThe CG will undergo a group and face-to-face training-explanatory session, where the importance of maintaining the usual level of cognitive activity will be emphasized. | Behavioural | Control Group |
Primary outcome
MEC-35 (Spanish version of Folstein's Mini-Mental)
Time frame: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
The primary outcome variable is MEC-35 (Spanish version of Folstein's Mini-Mental): the most widely used cognitive test in Primary Care, adapted by Lobo to the Spanish population (Lobo, A., et al 1979). It evaluates 8 components: temporal orientation, spatial orientation, fixation memory, attention, calculation, short-term memory, language and praxis. Its sensitivity is 85-90% and its specificity 69% (Lobo, A. et al 1999). Although its cut-off point for detecting cognitive impairment is 24, in NC, scores between 28-35 points are considered (Friedman et al., 2012; Vinyoles Bargalló et al., 2002).
Cognitive Reserve Questionnaire (CRQ)
Time frame: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
To determine the level of cognitive reserve (Landenberger et al., 2019) the most suitable questionnaire is the Cognitive Reserve Questionnaire (CRQ) (Rami et al., 2011). It has eight items with between three and six response options. Each item relieves a CR factor: schooling, parental schooling, courses, occupation, musical training, languages, reading and intellectual games. The maximum score is 25 points. Between 7 and 9 points is considered a medium-low range of CR. Between 10-14 points medium-high range, and ≥15 points, high CR. It is an instrument with high reliability and acceptable convergent validity (Martino et al., 2021).
5 secondary outcomes
Set-Test
Time frame: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
The SDMT or Symbols and Digits Test
Time frame: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
Color Word Stroop Test (CWST)
Time frame: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
Verbal Learning Test (TAVEC)
Time frame: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
Mobile Device Proficiency Questionnaire in Short Form (MDPQ-16)
Time frame: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.
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 12 Dec 2024.
- Derived from this study: PubMed 42400967Calatayud E, Olivan-Blazquez B, Aguilar-Latorre A, Cuenca-Zaldivar JN, Magallon-Botaya RM, Gomez-Soria I. Post-intervention effectiveness of a computerized personalized cognitive stimulation program adapted according to cognitive reserve in older adults without cognitive impairment in Primary Care: A randomized clinical trial. Arch Gerontol Geriatr. 2026 Nov;150:106348. doi: 10.1016/j.archger.2026.106348. Epub 2026 Jun 27.
- Derived from this study: PubMed 41060253Calatayud E, Olivan-Blazquez B, Aguilar-Latorre A, Cuenca-Zaldivar JN, Magallon-Botaya RM, Gomez-Soria I. Digital Competence and Cognitive Reserve in Relation to Different Domains of Cognitive Functioning in Older Adults and Factors Modulating This Association: A Cross-Sectional Study of a Randomized Clinical Trial. Geriatr Gerontol Int. 2025 Nov;25(11):1525-1535. doi: 10.1111/ggi.70199. Epub 2025 Oct 8.
- Individual participant dataSharing planned: Yes. The primary objective of this plan is to disseminate individual participant data (IPD) from our research study to a wide audience of researchers and stakeholders. By publishing in open-access journals and presenting at conferences, the investigators aim to maximize the visibility and accessibility of our data, fostering collaboration and advancing scientific knowledge in our field.
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
Parkinson's Disease, Dementia
Recruiting
Buddy-Up Dyadic Physical Activity Program for Persons With Dementia and Family Caregivers
Cognitive Impairment, Mild, Dementia, Mild
Recruiting
ENACT Program on Auditory Perception and Function, Cognitive Function and Health-related Quality of Life
Hearing Loss, Cognitive Impairment, Mild
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized cognitive stimulation program and Face-to-face training-explanatory session in people with Mild Cognitive Impairment and Cognitive Dysfunction, run by Universidad de Zaragoza at 1 site in Spain.
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 5 inclusion and 5 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 12 Dec 2024. 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 Spain. 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 Rosa Magallón Botaya (+34 622 71 97 59, gaiap.contacto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MEC-35 (Spanish version of Folstein's Mini-Mental) (time frame: An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.). The study lists 2 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 NCT06279325, which also lists 2 linked publications.
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 12 Dec 2024.