Alzheimer DiseaseNCT07290686
Evaluation of the Effectiveness and Safety of Transcranial Direct Current Stimulation in Combination With Nasal Near Infrared Stimulation to Improve Cognitive Functions and Quality of Life in Elderly People With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD).
A study testing tDCS stimulation, tDCS and iNIRS stimulation in people with Alzheimer Disease and Mild Cognitive Impairment, run by Medical University of Lodz at 1 site in Poland.
Trial summary
Alzheimer's disease (AD) and mild cognitive impairment (MCI) are progressive neurodegenerative conditions with limited therapeutic options. Today, around 30 million people worldwide suffer from Alzheimer's dementia. Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- tDCS stimulation, tDCS and iNIRS stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2024to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of MCI/AD
- MMSE 12-26 points
- ADAS- COG > 17 points
- signed inform consent form
- minimum 8 years of education
- stable drug doses for minimum 3 months
Who cannot join
- diagnosis of mental disability, schizophrenia, bipolar disorder, depression, alcohol and/or drug addiction,
- unstable somatic state
- lack of signed inform consent form
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz
Lodz, Łódź Voivodeship, 92-213
About this study
Official title: Evaluation of the Effectiveness and Safety of an Innovative, Non-pharmacological Method Using Transcranial Direct Current Stimulation in Combination With Cognitive Training and Nasal Near Infrared Stimulation to Improve Cognitive Functions and Quality of Life in Elderly People With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD).
Alzheimer's disease (AD) and mild cognitive impairment (MCI) are progressive neurodegenerative conditions with limited therapeutic options. Today, around 30 million people worldwide suffer from Alzheimer's dementia. According to WHO predictions, the number of people affected by Alzheimer's disease in 2030 will amount to 65 million, and in 2050 nearly 115 million This means that the number of people suffering from Alzheimer's disease will triple in the next 30 years. The exact cause of Alzheimer's disease is still unknown. The amyloid hypothesis assumes that the accumulation of insoluble β-amyloid 42 aggregates in the central nervous system (CNS) triggers tau hyperphosphorylation (taupathy) and neurodegeneration in AD from the preclinical stage to dementia. In the 1990s, pharmacological treatment of Alzheimer's disease was introduced, but numerous studies indicate its limited effectiveness. Despite many attempts, there is currently no effective drug to delay the course of Alzheimer's disease. In recent years, there have been scientific reports indicating that the use of neuromodulatory therapies has a positive effect on the cognitive functions, behavior and daily functioning of AD patients.
Neuromodulation techniques such as transcranial direct current stimulation (tDCS) and photobiomodulation (PBM) have shown promise in improving cognitive function, but their combined effects remain underexplored.
The aim of the current project is to develop an effective and safe therapeutic procedure based on transcranial direct current stimulation (tDCS) therapy enriched with near infrared nasal stimulation (iNIRS) in patients diagnosed with mild cognitive impairment (MCI) and Alzheimer's disease (AD).
Read the detailed description
The aim of the current project is to develop an effective and safe therapeutic procedure based on transcranial direct current stimulation (tDCS) therapy enriched with cognitive training and near infrared nasal stimulation (iNIRS) in patients diagnosed with mild cognitive impairment (MCI) and Alzheimer's disease (AD) . The project will also evaluate the effectiveness of the selected therapeutic method and its impact on the improvement of cognitive functions of patients, including memory, attention, concentration, executive and language functions, as well as the presence of neuropsychiatric symptoms / behavioral disorders in patients and the quality of life of patients.
People meeting the inclusion criteria will be invited to participate in the study and will be provided with and written information about the research project and a voluntary, informed consent form.
Clinical evaluation of patients using the following scales: Mini Mental State Examinaton, Alzheimers Disease Assessment Scale, Neuropsychiatric Inventory Questionnaire, Geriatric Depression Scale, Hachiński Ischemic Index, Rey-RAVLT Fifteen Words Test. Cognitive assessments were performed at baseline, at the end of the procedure (within the three days after the last treatment session), and after 12 weeks of follow-up.
Clinical and demographic data: age, sex, education, the course of the disease to date, comorbidities, medications taken, smoking.
Patients will be randomly assigned to two parallel research groups - an active group receiving combination therapy with tDCS with cognitive exercise and nasal near infrared stimulation and placebo group with tDCS sham without cognitive training and sham nasal stimulation.
The procedure will include daily (5 out of 7 days a week) tDCS sessions lasting a total of 20 minutes. tDCS will be delivered at 2 mA with the anode at F3 (according to the 10-20 EEG electrode mounting system) and the cathode in F4, covering the left and right dorsolateral frontal cortexes, respectively.
During the tDCS procedure, patients received intranasal near-infrared stimulation through the device, utilizing an IR diode with the following parameters: 850nm wavelength, 40Hz pulse frequency, and a 50% duty cycle. Stimulation was administered for 20 minutes, five days a week, consecutively. Both stimulations were administered simultaneously.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- tDCS stimulation, tDCS, iNIRS stimulation, iNIRS
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS stimulationDevice
tDCS delivered with the anode at F3 (according to the 10-20 EEG electrode mounting system) and the cathode in F4, covering the left and right dorsolateral frontal cortexes, respectively.
tDCSDevice
tDCS delivered with the anode at F3 (according to the 10-20 EEG electrode mounting system) and the cathode in F4, covering the left and right dorsolateral frontal cortexes, respectively.
iNIRS stimulationDevice
intra-nasal
iNIRSDevice
intra-nasal
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS stimulation | Active comparator | 50 sessions of active stimulation of current intensity 2mA, stimulation time 20 minutes Receives: Device: tDCS stimulation |
| Placebo tDCS stimulation | Placebo comparator | 50 sessions of sham stimulation lasting only 30 seconds Receives: Device: tDCS |
| Active iNIRS stimulation | Active comparator | 50 sessions of active stimulation of intranasal near- infrared of 850 wavelength IR diode Receives: Device: iNIRS stimulation |
| Placebo iNIRS stimulation | Placebo comparator | 50 sessions of sham stimulation lasting only 30 seconds Receives: Device: iNIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive functions assessed by MMSE scale
change over time of cognitive functions measured as a change in amount of points during MMSE scale assestment. Change will be evaluated as overall reasult of scale and also as result in every assest field (according to MMSE scale). Assessment conducted on baseline, up to 3 days after end of the procedure and after 12 weeks.
Measured: up to 12 weeks
cognitive functions assessed by ADAS- Cog scale
change over time of cognitive functions measured as a change in amount of points during ADAS-Cog scale assestment. Change will be evaluated as overall reasult of scale and also as result in every assest field (according to ADAS-Cog scale). Assessment conducted on baseline, up to 3 days after end of the procedure and after 12 weeks.
Measured: up to 12 weeks
cognitive functions assessed by RAVLT
change over time of cognitive functions measured as a change in amount of points during RAVLT assestment. Change will be evaluated as overall reasult of scale and also as result in every assest field (according to RAVLT). Assessment conducted on baseline, up to 3 days after end of the procedure and after 12 weeks.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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 Alzheimer DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Kazmierski, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290686
- Sponsor's protocol ID
- RNN/336/20/KE
- Status last verified
- Dec 2025
- First submitted
- 14 Dec 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wozniak-Mital J, Rasmus P, Strombek-Milczarek M, Kazmierski J. The Impact of Transcranial Direct Stimulation Therapy Combined with Intranasal Near-Infrared Stimulation on Cognitive Performance in Patients with Mild Cognitive Impairment and Alzheimer's Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Study. Neurol Ther. 2026 Aug;15(4):1511-1522. doi: 10.1007/s40120-026-00927-x. Epub 2026 Apr 17.
PubMed 41996008
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Safety of an Innovative, Non-pharmacological Method Using Transcranial Direct Current Stimulation in Combination With Cognitive Training and Nasal Near Infrared Stimulation to Improve Cognitive Functions and Quality of Life in Elderly People With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD).
- ClinicalTrials.gov ID
- NCT07290686
- Acronym / sponsor ID
- RNN/336/20/KE
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 18 Dec 2025 (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.
Alzheimer's disease (AD) and mild cognitive impairment (MCI) are progressive neurodegenerative conditions with limited therapeutic options. Today, around 30 million people worldwide suffer from Alzheimer's dementia. According to WHO predictions, the number of people affected by Alzheimer's disease in 2030 will amount to 65 million, and in 2050 nearly 115 million This means that the number of people suffering from Alzheimer's disease will triple in the next 30 years. The exact cause of Alzheimer's disease is still unknown. The amyloid hypothesis assumes that the accumulation of insoluble β-amyloid 42 aggregates in the central nervous system (CNS) triggers tau hyperphosphorylation (taupathy) and neurodegeneration in AD from the preclinical stage to dementia. In the 1990s, pharmacological treatment of Alzheimer's disease was introduced, but numerous studies indicate its limited effectiveness. Despite many attempts, there is currently no effective drug to delay the course of Alzheimer's disease. In recent years, there have been scientific reports indicating that the use of neuromodulatory therapies has a positive effect on the cognitive functions, behavior and daily functioning of AD patients.
Neuromodulation techniques such as transcranial direct current stimulation (tDCS) and photobiomodulation (PBM) have shown promise in improving cognitive function, but their combined effects remain underexplored.
The aim of the current project is to develop an effective and safe therapeutic procedure based on transcranial direct current stimulation (tDCS) therapy enriched with near infrared nasal stimulation (iNIRS) in patients diagnosed with mild cognitive impairment (MCI) and Alzheimer's disease (AD).
Detailed description
The aim of the current project is to develop an effective and safe therapeutic procedure based on transcranial direct current stimulation (tDCS) therapy enriched with cognitive training and near infrared nasal stimulation (iNIRS) in patients diagnosed with mild cognitive impairment (MCI) and Alzheimer's disease (AD) . The project will also evaluate the effectiveness of the selected therapeutic method and its impact on the improvement of cognitive functions of patients, including memory, attention, concentration, executive and language functions, as well as the presence of neuropsychiatric symptoms / behavioral disorders in patients and the quality of life of patients.
People meeting the inclusion criteria will be invited to participate in the study and will be provided with and written information about the research project and a voluntary, informed consent form.
Clinical evaluation of patients using the following scales: Mini Mental State Examinaton, Alzheimers Disease Assessment Scale, Neuropsychiatric Inventory Questionnaire, Geriatric Depression Scale, Hachiński Ischemic Index, Rey-RAVLT Fifteen Words Test. Cognitive assessments were performed at baseline, at the end of the procedure (within the three days after the last treatment session), and after 12 weeks of follow-up.
Clinical and demographic data: age, sex, education, the course of the disease to date, comorbidities, medications taken, smoking.
Patients will be randomly assigned to two parallel research groups - an active group receiving combination therapy with tDCS with cognitive exercise and nasal near infrared stimulation and placebo group with tDCS sham without cognitive training and sham nasal stimulation.
The procedure will include daily (5 out of 7 days a week) tDCS sessions lasting a total of 20 minutes. tDCS will be delivered at 2 mA with the anode at F3 (according to the 10-20 EEG electrode mounting system) and the cathode in F4, covering the left and right dorsolateral frontal cortexes, respectively.
During the tDCS procedure, patients received intranasal near-infrared stimulation through the device, utilizing an IR diode with the following parameters: 850nm wavelength, 40Hz pulse frequency, and a 50% duty cycle. Stimulation was administered for 20 minutes, five days a week, consecutively. Both stimulations were administered simultaneously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active tDCS stimulation | Active comparator | Device: tDCS stimulation50 sessions of active stimulation of current intensity 2mA, stimulation time 20 minutes |
| Placebo tDCS stimulation | Placebo comparator | Device: tDCS50 sessions of sham stimulation lasting only 30 seconds |
| Active iNIRS stimulation | Active comparator | Device: iNIRS stimulation50 sessions of active stimulation of intranasal near- infrared of 850 wavelength IR diode |
| Placebo iNIRS stimulation | Placebo comparator | Device: iNIRS50 sessions of sham stimulation lasting only 30 seconds |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of MCI/AD
- MMSE 12-26 points
- ADAS- COG > 17 points
- signed inform consent form
- minimum 8 years of education
Key exclusion criteria (3 listed)
- diagnosis of mental disability, schizophrenia, bipolar disorder, depression, alcohol and/or drug addiction,
- unstable somatic state
- lack of signed inform consent form
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 |
|---|---|---|
| tDCS stimulationtDCS delivered with the anode at F3 (according to the 10-20 EEG electrode mounting system) and the cathode in F4, covering the left and right dorsolateral frontal cortexes, respectively. | Device | Active tDCS stimulation |
| tDCStDCS delivered with the anode at F3 (according to the 10-20 EEG electrode mounting system) and the cathode in F4, covering the left and right dorsolateral frontal cortexes, respectively. | Device | Placebo tDCS stimulation |
| iNIRS stimulationintra-nasal | Device | Active iNIRS stimulation |
| iNIRSintra-nasal | Device | Placebo iNIRS stimulation |
Primary outcome
cognitive functions assessed by MMSE scale
Time frame: up to 12 weeks
change over time of cognitive functions measured as a change in amount of points during MMSE scale assestment. Change will be evaluated as overall reasult of scale and also as result in every assest field (according to MMSE scale). Assessment conducted on baseline, up to 3 days after end of the procedure and after 12 weeks.
cognitive functions assessed by ADAS- Cog scale
Time frame: up to 12 weeks
change over time of cognitive functions measured as a change in amount of points during ADAS-Cog scale assestment. Change will be evaluated as overall reasult of scale and also as result in every assest field (according to ADAS-Cog scale). Assessment conducted on baseline, up to 3 days after end of the procedure and after 12 weeks.
cognitive functions assessed by RAVLT
Time frame: up to 12 weeks
change over time of cognitive functions measured as a change in amount of points during RAVLT assestment. Change will be evaluated as overall reasult of scale and also as result in every assest field (according to RAVLT). Assessment conducted on baseline, up to 3 days after end of the procedure and after 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 41996008Wozniak-Mital J, Rasmus P, Strombek-Milczarek M, Kazmierski J. The Impact of Transcranial Direct Stimulation Therapy Combined with Intranasal Near-Infrared Stimulation on Cognitive Performance in Patients with Mild Cognitive Impairment and Alzheimer's Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Study. Neurol Ther. 2026 Aug;15(4):1511-1522. doi: 10.1007/s40120-026-00927-x. Epub 2026 Apr 17.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS stimulation, tDCS and iNIRS stimulation in people with Alzheimer Disease and Mild Cognitive Impairment, run by Medical University of Lodz at 1 site in Poland.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 18 Dec 2025. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
cognitive functions assessed by MMSE scale (time frame: up to 12 weeks). The study lists 3 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 NCT07290686, 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 18 Dec 2025.