Prodromal Alzheimer's DiseaseCOMBINA-COGNCT06861231
Combined tDCS and Cognitive Training in Alzheimer's
A study testing Transcraneal Direct Current Stimulation (tDCS)- Active and Cognitive Training (CT) in people with Prodromal Alzheimer's Disease, run by University of Valencia at 1 site in Spain.
Trial summary
The General Objective of the study is to evaluate the short- and long-term efficacy of combining transcranial Direct Current Stimulation (tDCS) and cognitive training (CT) in patients with mild cognitive impairment due to Alzheimer's disease. A randomized, single-blind, placebo-controlled design will be applied. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Prodromal Alzheimer's Disease
- What is being tested?
- Transcraneal Direct Current Stimulation (tDCS)- Active and Cognitive Training (CT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 4 Oct 2024to 16 Apr 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Participants were eligible if they met criteria for mild cognitive impairment due to Alzheimer's disease (MCI due to AD), defined as a score ≥ 23 on the Mini-Mental State Examination (MMSE) and classification at Stage 3 on the Global Deterioration Scale (GDS).
Exclusion criteria included contraindications to transcranial direct current stimulation (tDCS), such as intracranial metal implants or intracranial hypertension, as well as the presence of significant cerebrovascular disease or severe psychiatric symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Intervention Using Transcranial Direct Current Stimulation and Cognitive Training in Alzheimer's Type Dementia Patients
The General Objective of the study is to evaluate the short- and long-term efficacy of combining transcranial Direct Current Stimulation (tDCS) and cognitive training (CT) in patients with mild cognitive impairment due to Alzheimer's disease. A randomized, single-blind, placebo-controlled design will be applied. An inter-subject design with two groups will be used: a. Active tDCS + concurrent CT and b. Sham tDCS + concurrent CT. Evaluations will be taken at pre-test, post-test, and follow-up one month later. The hypothesis comparing active and sham tDCS with concurrent CT is that, although both groups should improve due to concurrent CT, it is expected that the active tDCS group will show significantly greater improvements in post-treatment. Additionally, these improvements should be maintained in the long-term follow-up in the active tDCS group, while in the sham tDCS group, a partial loss of gains is expected at follow-up.
Transcranial Direct Current Stimulation (tDCS): HDC stimulators (Newronika TM, Milan, Italy) will be used. For active stimulation, the current intensity will be constant at 2 mA, with a stimulation time of 20 minutes daily for 10 days, and an initial and final ramp of 30 seconds. For the placebo group, current will only be applied during the initial and final ramps to generate the sensation of active stimulation. A neoprene cap with carbon rubber electrodes and sponges soaked in saline solution (5 x 5 cm) will be used. The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC), and the cathode over the right supraorbital area (rSO).
Cognitive Training (CT): The CT will consist of 10 sessions of 50 minutes each, based on tasks involving executive functions and memory, including categorization, answering questions, short stories, problem-solving, recalling autobiographical moments, planning simple tasks, and schedule analysis.
Read the detailed description
As a preliminary step to this study, it should be noted that contact with patients will be obtained from the Neurology service at the Consorcio Hospital General Universitario. Before starting the research and to obtain subject participation, the service will inform potential participants about the possibility of being included in a study related to electrical stimulation, noting that they will have to receive intervention through transcranial Direct Current Stimulation (tDCS) and Cognitive Training (CT) for ten days. Once an initial commitment to possible participation is obtained from the patients, they will be informed that they will receive a phone call from the research team at the University of Valencia to schedule an in-person appointment where they will be provided with detailed information.
During this first appointment, held at the assigned health center or specialty center, the intervention procedure will be explained in more detail, and informed consent will be obtained from those subjects who decide to participate. It is important to highlight that the information regarding the procedure will emphasize aspects related to the safety and tolerability of the treatment, adherence to it, and the ease of application given its home-based nature.
From this point, the clinical interview will aim to assess the general health status and assess compliance with inclusion and exclusion criteria.; a neuropsychological evaluation will also be performed, although participants will be given the option to undergo this first evaluation during a second appointment. It should be noted that the total duration of the evaluation for participants in the early dementia group may be approximately 50 minutes.
Once the baseline evaluation is available, a coordinated schedule with the participants will be set to establish the start of the treatment and its continuity for the assigned duration; this aspect is crucial as a commitment to continuity from the participants is necessary. To facilitate this, a flexible start date will be provided to avoid any planned interruptions during the process. Additionally, given its home-based nature, the necessary information for home visits will be obtained, and an approximate time for the intervention will be established to ensure consistency. For this process, a psychologist hired for this purpose will visit the homes of the participants to carry out the stimulation. The psychologist administering the intervention was not blinded to group allocation, whereas participants and outcome assessors remained blinded.
The main critical point of this project is believed to be treatment adherence. Multiple sessions require subjects to repeatedly travel to the treatment location, posing a significant and often insurmountable burden for patients and their caregivers, along with substantial time and cost for service providers, especially as sample size increases. This difficulty often results in a high dropout rate. Providing tDCS and CT treatment at home, as proposed in this project, can reduce the burden on patients and their families by eliminating the need to travel to medical or research facilities for each treatment session, promoting adherence and compliance with the treatment. Therefore, implementing the outlined procedure in this research appears necessary not only to evaluate clinical efficacy but also to ensure the correct execution of stimulations and prevent dropouts.
Additionally, it is believed that one of the strengths and a key contingency strategy for addressing the mentioned critical point is the team's ability to adapt to contact with this type of patient and their caregivers. In this regard, it is crucial to implement an innovative paradigm, already applied in previous projects and leading global healthcare transformation, known as Patient Centricity (patient-centered care). Patient participation and care are essential aspects of research and procedural development, as well as disease management. Health outcomes depend on patient involvement, and there is a clear need to partner with them in the research, development, implementation, and advancement of health procedures to achieve better results. Creating a patient-centered solution involves obtaining input from patients and their caregivers, as is the case with this project, and making decisions based on their needs and perspectives. Humanizing science contributes to better acceptance, improving patient relationships and safety, and helping to prevent errors.
Considering the study groups, 3 repeated measures (pre, post, and follow-up), a statistical power of 95%, and a 95% confidence interval with an estimated effect size of η² = 0.16, it is estimated that an N = 30 participants would be needed, which means 15 subjects per group. However, due to recruitment constraints, the final sample consisted of 22 participants, which may have reduced the statistical power of the study.
The data will be analyzed using linear mixed-effects models to account for the repeated measures structure of the data, with group (active vs. sham) as a between-subjects factor and time (pre, post, follow-up) as a within-subjects factor. The efficacy of tDCS will be assessed by examining the interaction between group and time.
- Conditions
- Prodromal Alzheimer's Disease
- Being tested
- Transcraneal Direct Current Stimulation (tDCS)- Active, Transcranial Direct Current Stimulation (tDCS)- Sham, Cognitive Training (CT)
- Keywords
- Cognitive impairment, Transcranial direct current stimulation, Cognitive training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcraneal Direct Current Stimulation (tDCS)- ActiveDevice
The stimulation will use a neoprene cap with carbon rubber electrodes and sponges soaked in saline solution (5x5 cm). The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC), and the cathode over the right supraorbital area (rSO). Constant current intensity of 2mA and a stimulation time of 20 minutes per day for 10 days will be applied, with an initial and final ramp of 30 seconds.
Transcranial Direct Current Stimulation (tDCS)- ShamDevice
Participants assigned to the sham tDCS group will also receive 10 home-based sessions of 20 minutes each. However, to mimic the sensation of active stimulation without delivering therapeutic current, the stimulator will only apply current during the initial and final 30-second ramp periods. The device will remain on for 20 minutes, but no current will be applied after the first ramp, simulating an active procedure without physiological effect.
Cognitive Training (CT)Behavioural
All participants will complete 10 home-based cognitive training sessions, each lasting 50 minutes. The training will include structured tasks focused on executive function and memory, such as categorization, problem-solving, autobiographical recall, planning, and schedule analysis. Instructions will be provided at the start of each session, and participants will work independently or with caregiver support.
| Study group | Role | What they receive |
|---|---|---|
| tDCS active and cognitive training | Experimental | tDCS: HDC stimulator will be used. For active stimulation, it will be programmed with a constant current intensity of 2mA and a stimulation time of 20 minutes daily for 10 days, with an initial and final ramp of 30 seconds. A neoprene cap based on the international 10-10 EEG system will be used for current passage to the skull. The electrodes will have two sponges (5 x 5 cm) soaked in saline solution for contact with the skull. The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC), and the cathode will be placed over the right supraorbital area (rSO).
Cognitive training consists of a total of 10 sessions lasting 50 minutes each. These sessions will primarily focus on tasks involving executive functions and memory for a similar duration in each session. At the beginning of the sessions, instructions will be explained, followed by handing out activity sheets. The emphasis will not be on the outcome but on the cognitive activation process. Receives: Device: Transcraneal Direct Current Stimulation (tDCS)- Active; Behavioral: Cognitive Training (CT) |
| tDCS sham and cognitive training | Active comparator | For the active comparator group, the stimulator will be programmed so that patients will receive direct current only during the ramps to generate the sensation of the current. Thus, it will enter a current pause after completing the initial ramp and will be activated in the final seconds during the final ramp. The cognitive training program will have the same characteristics as in the experimental group. Receives: Device: Transcranial Direct Current Stimulation (tDCS)- Sham; Behavioral: Cognitive Training (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE) Scores at Baseline, Post-intervention, and Follow up
The Mini-Mental State Examination (MMSE) was used as an index of global cognitive functioning. MMSE scores range from 0 to 30, with higher scores indicating lower cognitive impairment and therefore a better outcome. This test was designed to estimate the existence and severity of cognitive impairment. Participants with scores equal to or below 23 will be considered cognitively impaired. Assessments were conducted at baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment). Post-intervention minus baseline difference scores were calculated, with a possible range from -30 to 30; positive scores reflect improvement.
Measured: Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
Secondary outcomes (2)
Digits Wechsler Intelligence Scale for Adults-III (WAIS-III) Scores at Baseline, Post-intervention, and Follow up
Direct and inverse digits of the Wechsler Intelligence Scale for Adults-III (Wechsler, 2001) were used to assess attentional capacity by exposing participants to increasing amounts of information. On the direct digits task, which assesses immediate recall, participants repeated the sequence of numbers in the same order in which they were presented by the examiner. On the inverse digits task, which assesses working memory and mental flexibility, participants repeated the digits in reverse order. Both tests are scored by assigning one point for each correct item, with scores ranging from 0 to 16; higher scores indicate better attentional performance and therefore a better outcome. Assessments were conducted at baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment). Post-intervention minus baseline difference scores were calculated, with a possible range from -16 to 16; positive scores reflect improvement.
Measured: Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
Complutense Verbal Learning Test (TAVEC) - Memory Scores at Baseline, Post-intervention, and Follow up
The Complutense Verbal Learning Test (TAVEC) presents a list of 16 words that, after being read by the evaluator, must be repeated by the participant. The list is repeated five times (trials), and the participant is asked to recall the 16 words after each trial. The test was administered to evaluate immediate memory (Trial 1) and learning ability (Trial 5). Scores for each trial range from 0 to 16, with higher scores indicating better memory performance and therefore a better outcome. Assessments were conducted at baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment). Post-intervention minus baseline difference scores were calculated, with a possible range from -16 to 16; positive scores reflect improvement.
Measured: Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start4 Oct 2024
- Primary completion14 Mar 2026
- Study completion16 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Prodromal Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Carlos Melendez, University of Valencia
- Investigators
- Juan C Melendez, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861231
- Sponsor's protocol ID
- 2601758
- Acronym
- COMBINA-COG
- Status last verified
- Apr 2026
- First submitted
- 28 Feb 2025
- Last updated
- 16 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The main reason for not sharing the individual participant data (IPD) description plan is to preserve the confidentiality and privacy of clinical trial participants. The protection of participants' personal and medical information is considered a top priority in this study.
Publications
Melendez JC, Satorres E, Pitarque A, Delhom I, Real E, Escudero J. Effectiveness of tDCS at Improving Recognition and Reducing False Memories in Older Adults. Int J Environ Res Public Health. 2021 Feb 1;18(3):1317. doi: 10.3390/ijerph18031317.
PubMed 33535690Satorres E, Escudero Torrella J, Real E, Pitarque A, Delhom I, Melendez JC. Home-based transcranial direct current stimulation in mild neurocognitive disorder due to possible Alzheimer's disease. A randomised, single-blind, controlled-placebo study. Front Psychol. 2023 Jan 3;13:1071737. doi: 10.3389/fpsyg.2022.1071737. eCollection 2022.
PubMed 36660288Satorres E, Melendez JC, Pitarque A, Real E, Abella M, Escudero J. Enhancing Immediate Memory, Potential Learning, and Working Memory with Transcranial Direct Current Stimulation in Healthy Older Adults. Int J Environ Res Public Health. 2022 Oct 5;19(19):12716. doi: 10.3390/ijerph191912716.
PubMed 36232016Hill AT, Fitzgerald PB, Hoy KE. Effects of Anodal Transcranial Direct Current Stimulation on Working Memory: A Systematic Review and Meta-Analysis of Findings From Healthy and Neuropsychiatric Populations. Brain Stimul. 2016 Mar-Apr;9(2):197-208. doi: 10.1016/j.brs.2015.10.006. Epub 2015 Oct 23.
PubMed 26597929Bahar-Fuchs A, Martyr A, Goh AM, Sabates J, Clare L. Cognitive training for people with mild to moderate dementia. Cochrane Database Syst Rev. 2019 Mar 25;3(3):CD013069. doi: 10.1002/14651858.CD013069.pub2.
PubMed 30909318Gates NJ, Vernooij RW, Di Nisio M, Karim S, March E, Martinez G, Rutjes AW. Computerised cognitive training for preventing dementia in people with mild cognitive impairment. Cochrane Database Syst Rev. 2019 Mar 13;3(3):CD012279. doi: 10.1002/14651858.CD012279.pub2.
PubMed 30864747Melendez JC, Escudero J, Satorres E, Pitarque A, Marti-Hoyos I, Gonzalez-Moreno J. Combined home-delivered transcranial direct current stimulation and cognitive training in older adults with mild cognitive impairment due to Alzheimer's disease: a randomized, single-blind, sham-controlled trial. BMC Geriatr. 2026 Apr 11;26(1):715. doi: 10.1186/s12877-026-07481-z.
PubMed 41965602
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Intervention Using Transcranial Direct Current Stimulation and Cognitive Training in Alzheimer's Type Dementia Patients
- ClinicalTrials.gov ID
- NCT06861231
- Acronym / sponsor ID
- COMBINA-COG / 2601758
- Conditions
- Prodromal Alzheimer's Disease
- Keywords
- Cognitive impairment, Transcranial direct current stimulation, Cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 14 Mar 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 6 Mar 2025 (actual)
- Results
- Posted 16 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The General Objective of the study is to evaluate the short- and long-term efficacy of combining transcranial Direct Current Stimulation (tDCS) and cognitive training (CT) in patients with mild cognitive impairment due to Alzheimer's disease. A randomized, single-blind, placebo-controlled design will be applied. An inter-subject design with two groups will be used: a. Active tDCS + concurrent CT and b. Sham tDCS + concurrent CT. Evaluations will be taken at pre-test, post-test, and follow-up one month later. The hypothesis comparing active and sham tDCS with concurrent CT is that, although both groups should improve due to concurrent CT, it is expected that the active tDCS group will show significantly greater improvements in post-treatment. Additionally, these improvements should be maintained in the long-term follow-up in the active tDCS group, while in the sham tDCS group, a partial loss of gains is expected at follow-up.
Transcranial Direct Current Stimulation (tDCS): HDC stimulators (Newronika TM, Milan, Italy) will be used. For active stimulation, the current intensity will be constant at 2 mA, with a stimulation time of 20 minutes daily for 10 days, and an initial and final ramp of 30 seconds. For the placebo group, current will only be applied during the initial and final ramps to generate the sensation of active stimulation. A neoprene cap with carbon rubber electrodes and sponges soaked in saline solution (5 x 5 cm) will be used. The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC), and the cathode over the right supraorbital area (rSO).
Cognitive Training (CT): The CT will consist of 10 sessions of 50 minutes each, based on tasks involving executive functions and memory, including categorization, answering questions, short stories, problem-solving, recalling autobiographical moments, planning simple tasks, and schedule analysis.
Detailed description
As a preliminary step to this study, it should be noted that contact with patients will be obtained from the Neurology service at the Consorcio Hospital General Universitario. Before starting the research and to obtain subject participation, the service will inform potential participants about the possibility of being included in a study related to electrical stimulation, noting that they will have to receive intervention through transcranial Direct Current Stimulation (tDCS) and Cognitive Training (CT) for ten days. Once an initial commitment to possible participation is obtained from the patients, they will be informed that they will receive a phone call from the research team at the University of Valencia to schedule an in-person appointment where they will be provided with detailed information.
During this first appointment, held at the assigned health center or specialty center, the intervention procedure will be explained in more detail, and informed consent will be obtained from those subjects who decide to participate. It is important to highlight that the information regarding the procedure will emphasize aspects related to the safety and tolerability of the treatment, adherence to it, and the ease of application given its home-based nature.
From this point, the clinical interview will aim to assess the general health status and assess compliance with inclusion and exclusion criteria.; a neuropsychological evaluation will also be performed, although participants will be given the option to undergo this first evaluation during a second appointment. It should be noted that the total duration of the evaluation for participants in the early dementia group may be approximately 50 minutes.
Once the baseline evaluation is available, a coordinated schedule with the participants will be set to establish the start of the treatment and its continuity for the assigned duration; this aspect is crucial as a commitment to continuity from the participants is necessary. To facilitate this, a flexible start date will be provided to avoid any planned interruptions during the process. Additionally, given its home-based nature, the necessary information for home visits will be obtained, and an approximate time for the intervention will be established to ensure consistency. For this process, a psychologist hired for this purpose will visit the homes of the participants to carry out the stimulation. The psychologist administering the intervention was not blinded to group allocation, whereas participants and outcome assessors remained blinded.
The main critical point of this project is believed to be treatment adherence. Multiple sessions require subjects to repeatedly travel to the treatment location, posing a significant and often insurmountable burden for patients and their caregivers, along with substantial time and cost for service providers, especially as sample size increases. This difficulty often results in a high dropout rate. Providing tDCS and CT treatment at home, as proposed in this project, can reduce the burden on patients and their families by eliminating the need to travel to medical or research facilities for each treatment session, promoting adherence and compliance with the treatment. Therefore, implementing the outlined procedure in this research appears necessary not only to evaluate clinical efficacy but also to ensure the correct execution of stimulations and prevent dropouts.
Additionally, it is believed that one of the strengths and a key contingency strategy for addressing the mentioned critical point is the team's ability to adapt to contact with this type of patient and their caregivers. In this regard, it is crucial to implement an innovative paradigm, already applied in previous projects and leading global healthcare transformation, known as Patient Centricity (patient-centered care). Patient participation and care are essential aspects of research and procedural development, as well as disease management. Health outcomes depend on patient involvement, and there is a clear need to partner with them in the research, development, implementation, and advancement of health procedures to achieve better results. Creating a patient-centered solution involves obtaining input from patients and their caregivers, as is the case with this project, and making decisions based on their needs and perspectives. Humanizing science contributes to better acceptance, improving patient relationships and safety, and helping to prevent errors.
Considering the study groups, 3 repeated measures (pre, post, and follow-up), a statistical power of 95%, and a 95% confidence interval with an estimated effect size of η² = 0.16, it is estimated that an N = 30 participants would be needed, which means 15 subjects per group. However, due to recruitment constraints, the final sample consisted of 22 participants, which may have reduced the statistical power of the study.
The data will be analyzed using linear mixed-effects models to account for the repeated measures structure of the data, with group (active vs. sham) as a between-subjects factor and time (pre, post, follow-up) as a within-subjects factor. The efficacy of tDCS will be assessed by examining the interaction between group and time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS active and cognitive training | Experimental | Device: Transcraneal Direct Current Stimulation (tDCS)- Active, Behavioral: Cognitive Training (CT)tDCS: HDC stimulator will be used. For active stimulation, it will be programmed with a constant current intensity of 2mA and a stimulation time of 20 minutes daily for 10 days, with an initial and final ramp of 30 seconds. A neoprene cap based on the international 10-10 EEG system will be used for current passage to the skull. The electrodes will have two sponges (5 x 5 cm) soaked in saline solution for contact with the skull. The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC), and the cathode will be placed over the right supraorbital area (rSO). Cognitive training consists of a total of 10 sessions lasting 50 minutes each. These sessions will primarily focus on tasks involving executive functions and memory for a similar duration in each session. At the beginning of the sessions, instructions will be explained, followed by handing out activity sheets. The emphasis will not be on the outcome but on the cognitive activation process. |
| tDCS sham and cognitive training | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS)- Sham, Behavioral: Cognitive Training (CT)For the active comparator group, the stimulator will be programmed so that patients will receive direct current only during the ramps to generate the sensation of the current. Thus, it will enter a current pause after completing the initial ramp and will be activated in the final seconds during the final ramp. The cognitive training program will have the same characteristics as in the experimental group. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Transcraneal Direct Current Stimulation (tDCS)- ActiveThe stimulation will use a neoprene cap with carbon rubber electrodes and sponges soaked in saline solution (5x5 cm). The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC), and the cathode over the right supraorbital area (rSO). Constant current intensity of 2mA and a stimulation time of 20 minutes per day for 10 days will be applied, with an initial and final ramp of 30 seconds. | Device | tDCS active and cognitive training |
| Transcranial Direct Current Stimulation (tDCS)- ShamParticipants assigned to the sham tDCS group will also receive 10 home-based sessions of 20 minutes each. However, to mimic the sensation of active stimulation without delivering therapeutic current, the stimulator will only apply current during the initial and final 30-second ramp periods. The device will remain on for 20 minutes, but no current will be applied after the first ramp, simulating an active procedure without physiological effect. | Device | tDCS sham and cognitive training |
| Cognitive Training (CT)All participants will complete 10 home-based cognitive training sessions, each lasting 50 minutes. The training will include structured tasks focused on executive function and memory, such as categorization, problem-solving, autobiographical recall, planning, and schedule analysis. Instructions will be provided at the start of each session, and participants will work independently or with caregiver support. | Behavioural | tDCS active and cognitive training, tDCS sham and cognitive training |
Primary outcome
Mini-Mental State Examination (MMSE) Scores at Baseline, Post-intervention, and Follow up
Time frame: Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
The Mini-Mental State Examination (MMSE) was used as an index of global cognitive functioning. MMSE scores range from 0 to 30, with higher scores indicating lower cognitive impairment and therefore a better outcome. This test was designed to estimate the existence and severity of cognitive impairment. Participants with scores equal to or below 23 will be considered cognitively impaired. Assessments were conducted at baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment). Post-intervention minus baseline difference scores were calculated, with a possible range from -30 to 30; positive scores reflect improvement.
2 secondary outcomes
Digits Wechsler Intelligence Scale for Adults-III (WAIS-III) Scores at Baseline, Post-intervention, and Follow up
Time frame: Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
Complutense Verbal Learning Test (TAVEC) - Memory Scores at Baseline, Post-intervention, and Follow up
Time frame: Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33535690Melendez JC, Satorres E, Pitarque A, Delhom I, Real E, Escudero J. Effectiveness of tDCS at Improving Recognition and Reducing False Memories in Older Adults. Int J Environ Res Public Health. 2021 Feb 1;18(3):1317. doi: 10.3390/ijerph18031317.
- Results publication: PubMed 36660288Satorres E, Escudero Torrella J, Real E, Pitarque A, Delhom I, Melendez JC. Home-based transcranial direct current stimulation in mild neurocognitive disorder due to possible Alzheimer's disease. A randomised, single-blind, controlled-placebo study. Front Psychol. 2023 Jan 3;13:1071737. doi: 10.3389/fpsyg.2022.1071737. eCollection 2022.
- Results publication: PubMed 36232016Satorres E, Melendez JC, Pitarque A, Real E, Abella M, Escudero J. Enhancing Immediate Memory, Potential Learning, and Working Memory with Transcranial Direct Current Stimulation in Healthy Older Adults. Int J Environ Res Public Health. 2022 Oct 5;19(19):12716. doi: 10.3390/ijerph191912716.
- Results publication: PubMed 26597929Hill AT, Fitzgerald PB, Hoy KE. Effects of Anodal Transcranial Direct Current Stimulation on Working Memory: A Systematic Review and Meta-Analysis of Findings From Healthy and Neuropsychiatric Populations. Brain Stimul. 2016 Mar-Apr;9(2):197-208. doi: 10.1016/j.brs.2015.10.006. Epub 2015 Oct 23.
- Results publication: PubMed 30909318Bahar-Fuchs A, Martyr A, Goh AM, Sabates J, Clare L. Cognitive training for people with mild to moderate dementia. Cochrane Database Syst Rev. 2019 Mar 25;3(3):CD013069. doi: 10.1002/14651858.CD013069.pub2.
- Results publication: PubMed 30864747Gates NJ, Vernooij RW, Di Nisio M, Karim S, March E, Martinez G, Rutjes AW. Computerised cognitive training for preventing dementia in people with mild cognitive impairment. Cochrane Database Syst Rev. 2019 Mar 13;3(3):CD012279. doi: 10.1002/14651858.CD012279.pub2.
- Derived from this study: PubMed 41965602Melendez JC, Escudero J, Satorres E, Pitarque A, Marti-Hoyos I, Gonzalez-Moreno J. Combined home-delivered transcranial direct current stimulation and cognitive training in older adults with mild cognitive impairment due to Alzheimer's disease: a randomized, single-blind, sham-controlled trial. BMC Geriatr. 2026 Apr 11;26(1):715. doi: 10.1186/s12877-026-07481-z.
- Individual participant dataSharing planned: No. The main reason for not sharing the individual participant data (IPD) description plan is to preserve the confidentiality and privacy of clinical trial participants. The protection of participants' personal and medical information is considered a top priority in this study.
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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. This study is not recruiting at the moment.
Juan C Melendez, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcraneal Direct Current Stimulation (tDCS)- Active and Cognitive Training (CT) in people with Prodromal Alzheimer's Disease, run by University of Valencia 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?
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: finished, as of the sponsor's last update on 16 Jun 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 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?
Yes. Results are posted in the registry (first posted 16 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE) Scores at Baseline, Post-intervention, and Follow up (time frame: Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)). 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 NCT06861231, which also lists 7 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 16 Jun 2026.