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).

NCT07290686 | Completed DMC

• 1 other identifier: RNN/336/20/KE
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  up to 12 weeks

Study Arms (4)

Active tDCS stimulation

ACTIVE COMPARATOR

50 sessions of active stimulation of current intensity 2mA, stimulation time 20 minutes

Device: tDCS stimulation

Placebo tDCS stimulation

PLACEBO COMPARATOR

50 sessions of sham stimulation lasting only 30 seconds

Device: tDCS

Active iNIRS stimulation

ACTIVE COMPARATOR

50 sessions of active stimulation of intranasal near- infrared of 850 wavelength IR diode

Device: iNIRS stimulation

Placebo iNIRS stimulation

PLACEBO COMPARATOR

50 sessions of sham stimulation lasting only 30 seconds

Device: iNIRS

Interventions

tDCS stimulation DEVICE

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.

Active tDCS stimulation

tDCS DEVICE

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.

Placebo tDCS stimulation

iNIRS stimulation DEVICE

intra-nasal

Active iNIRS stimulation

iNIRS DEVICE

intra-nasal

Placebo iNIRS stimulation

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• diagnosis of mental disability, schizophrenia, bipolar disorder, depression, alcohol and/or drug addiction,
• unstable somatic state
• lack of signed inform consent form

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz

Lodz, Łódź Voivodeship, 92-213, Poland

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Professor of Medical University of Lodz

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 18, 2025
• Study Start: January 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)