Transcranial Alternating Current StimulationAD_tACSrehabNCT07839650

Transcranial Alternating Current Stimulation (tACS) Combined With Cognitive Training in Alzheimer's Disease

A study testing Transcranial Alternating Current Stimulation and Individualized Computerized Memory Training in people with Transcranial Alternating Current Stimulation and Alzheimer Disease (AD), run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The aim of the study is to evaluate the clinical and biological efficacy, as well as predictors of efficacy, of a home-based intervention combining transcranial alternating current stimulation (tACS) with individualized computerized cognitive training in patients with mild Alzheimer's disease (AD). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Transcranial Alternating Current Stimulation, Alzheimer Disease (AD), Alzheimer Dementia (AD)
What is being tested?: Transcranial Alternating Current Stimulation and Individualized Computerized Memory Training
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 2 sitesItaly
Study dates: 16 Sep 2026to Sep 2032
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients:
Male or female participants aged ≥18 years at the time of signing the informed consent form;
Clinical diagnosis of mild Alzheimer's disease (AD) according to current clinical criteria;
Availability of a caregiver who can assist the participant and who has successfully completed the required training for the use of the device at home.
Caregivers:
Male or female caregivers aged ≥18 years;
Compliance with participation in the in-hospital training;
Mini-Mental State Examination (MMSE) score >27/30.

Who cannot join

Age below that specified in the inclusion criteria;
Inability to understand;
Contraindications to tACS and TMS (e.g., presence of a cardiac pacemaker or metallic implants incompatible with electrical or magnetic fields, history of epilepsy, or current pregnancy, as assessed using the safety questionnaire).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Italy2 sites, 2 recruiting

IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli
Brescia, Brescia, 25125
Barbara Borroni, MD, +39 0303501358, bborroni@fatebenefratelli.eu
Barbara Borroni, MD
Recruiting
IRCCS S. Maria Nascente - Fondazione Don Carlo Gnocchi
Milan
Francesca Baglio, MD, +390240308951
Not yet recruiting

Other trials in Italy

About this study

Official title: Interventional Study to Evaluate the Effectiveness of Transcranial Alternating Current Stimulation (tACS) Combined With Cognitive Training on Cognitive Performance in Patients With Alzheimer's Disease

In neurodegenerative diseases, including AD, neurodegeneration is accompanied by alterations in brain oscillatory activity. Restoration of these oscillations through neuronal entrainment has shown beneficial effects in animal models, while previous studies in patients with AD have demonstrated that gamma-frequency tACS applied over the precuneus is safe and well tolerated and is associated with improvements in cognitive performance and cholinergic function, as well as modulation of brain oscillatory activity. Cognitive rehabilitation may also improve memory performance in patients with mild AD. Based on this evidence, the present study investigates a multimodal approach combining gamma-tACS with individualized computerized memory training.

The study is a multicenter, randomized, placebo-controlled, double-blind trial involving 30 participants with mild AD. Participants will be randomly assigned to one of two groups: Group 1 will receive real gamma-tACS for 8 weeks (5 sessions/week, 60 minutes/session) combined with cognitive training (2 sessions/week, 30 minutes/session); Group 2 will receive sham tACS according to the same schedule, combined with the same cognitive training. tACS will be applied over the precuneus. Treatment will initially be performed in the hospital and will subsequently be administered at home under remote supervision by the study team.

Assessments will be performed at baseline (T00), after 8 weeks of treatment (T08), and at follow-up visits at 16 weeks (T16) and 24 weeks (T24) from baseline. At each time point, participants will undergo clinical and neuropsychological assessment, blood sampling, and transcranial magnetic stimulation (TMS). The occurrence of adverse events will be monitored throughout the duration of the study.

The main objectives of the study are: 1) to evaluate the short- and long-term effects of the combined intervention on cognitive performance; 2) to investigate intervention-induced changes in biological markers of neurodegeneration, inflammation, and synaptic function; 3) to evaluate the effects of the intervention on cholinergic transmission through the TMS short-latency afferent inhibition (SAI) measure; and 4) to investigate potential predictors of treatment efficacy.

Conditions: Transcranial Alternating Current Stimulation, Alzheimer Disease (AD), Alzheimer Dementia (AD), Cognitive Rehabilitation
Being tested: Transcranial Alternating Current Stimulation, Sham Transcranial Alternating Current Stimulation, Individualized Computerized Memory Training
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Alternating Current StimulationDevice
40 at-home sessions (5 days/week for 8 weeks), each consisting of the application of tACS (real, 40 Hz) applied over the precuneus for a duration of 60 minutes each.
Sham Transcranial Alternating Current StimulationDevice
40 at-home sessions (5 days/week for 8 weeks), each consisting of the application of sham tACS applied over the precuneus for a duration of 60 minutes each. The electrode placement will be identical to that used for real stimulation. However, the electrical current will be automatically interrupted approximately 5 seconds after the start of stimulation, making it impossible for the participant to distinguish between sham and real stimulation.
Individualized Computerized Memory TrainingBehavioural
Participants will receive individualized computerized memory training for 8 weeks (2 sessions/week, 30 minutes/session) through synchronous telerehabilitation. The memory training will be individualized based on each participant's performance on the Face-Name Association Task (FNAT) and will use an errorless learning approach.

Study groups in NCT07839650
Study group	Role	What they receive
Real tACS	Experimental	Not described Receives: Device: Transcranial Alternating Current Stimulation; Behavioral: Individualized Computerized Memory Training
Sham tACS	Sham comparator	Not described Receives: Device: Sham Transcranial Alternating Current Stimulation; Behavioral: Individualized Computerized Memory Training

What is being measured

The primary outcome is the main question the study is designed to answer.

Mini-Mental State Examination (MMSE)
The global cognitive functioning will be assessed by Mini-Mental State Examination (MMSE); MMSE scores range from 0 to 30, with higher scores indicating a more preserved cognition.
Measured: Change from baseline to week 24
Semantic Fluency Test
Lexical-semantic access and executive functioning will be evaluated by Semantic Fluency Test. Participant is asked to generate as many words as possible from a given category within a limited time (60 seconds); higher scores indicate better performance.
Measured: Change from baseline to week 8, 16, and 24
Trail Making Test (TMT - A, B)
Executive function will be assessed using the Trail Making Test, including Part A (visual attention and processing speed) and Part B (task switching and cognitive flexibility). Higher completion times reflect poorer performance.
Measured: Change from baseline to week 8, 16, and 24
Rey Auditory Verbal Learning Test (RAVLT)
Verbal memory will be assessed using the Rey Auditory Verbal Learning Test (RAVLT), including immediate recall (sum of trials), delayed recall after 15 minutes. Scores reflect the number of correctly recalled items.
Measured: Change from baseline to week 8, 16 and 24
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-13)
The ADAS-Cog-13 consists of 13 tasks assessing cognitive domains including memory, language, praxis, orientation, and attention. Total scores range from 0 to 85, with higher scores indicating greater cognitive impairment.
Measured: Change from baseline to week 8, 16 and 24
Face-Name Associative Memory Test (FNAT)
The Face-Name Associative Memory Test is used to assess the participant's associative memory and is composed of encoding and retrieval phases, with higher scores indicating better function.
Measured: Change from baseline to week 8, 16 and 24
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
ADCS-ADL evaluates activities of daily living. The scores range from 0-78 with lower scores indicating more severe functional impairment.
Measured: Change from baseline to week 8, 16 and 24
Neuropsychiatric Inventory (NPI)
Neuropsychiatric Inventory (NPI) is designed to be a structured clinical interview about neuropsychiatric and behavioral symptoms; the score ranges from 0 (no symptoms) to 144 (severe symptoms).
Measured: Change from baseline to week 8, 16 and 24
Clinical Dementia Rating scale - Sum of Boxes (CDR-SoB)
The Clinical Dementia Rating-Sum of Boxes (CDR-SB) assesses cognitive and functional impairment across six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Total scores range from 0 to 18, with higher scores indicating greater cognitive and functional impairment.
Measured: Change from baseline to week 8, 16 and 24
Clinical Dementia Rating scale - Global Score (CDR-GS)
The Clinical Dementia Rating Global Score (CDR-GS) assesses the overall severity of cognitive and functional impairment across six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Global scores range from 0 to 3, with higher scores indicating greater impairment.
Measured: Change from baseline to week 8, 16 and 24
Zarit Burden Interview (ZBI)
The Zarit Burden Interview (ZBI) assesses the perceived burden experienced by caregivers of individuals with dementia. It consists of 22 items rated on a 5-point scale. Total scores range from 0 to 88, with higher scores indicating greater caregiver burden.
Measured: Change from baseline to week 8, 16, and 24

Secondary outcomes (7)

Change in SAI measurements
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of gamma tACS on short latency afferent inhibition (SAI), which is a marker of cholinergic transmission. SAI is expressed as percent of the unconditioned motor evoked potential.
Measured: Change from baseline to week 8, 16, and 24
Change From Baseline in Biological Marker Concentrations
A venous blood draw will be performed at each timepoint. Samples will be processed for serum, plasma, and DNA extraction. Changes from baseline in biological marker concentrations, including plasma p-tau217, will be evaluated over time.
Measured: Change from baseline to week 8, 16, and 24
Demographic characteristics
Demographic characteristics (age, gender, and level of education) will be evaluated as predictors of treatment efficacy and examined for associations with differential treatment response.
Measured: Baseline
Baseline Clinical Dementia Rating-Sum of Boxes (CDR-SB)
The Clinical Dementia Rating-Sum of Boxes (CDR-SB) will be used to assess disease severity at baseline and evaluated as a predictor of treatment efficacy and examined for associations with differential treatment response. The CDR-SB assesses cognitive and functional impairment across six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Total scores range from 0 to 18, with higher scores indicating greater disease severity.
Measured: Baseline
Baseline Clinical Dementia Rating - Global Score (CDR-GS)
The Clinical Dementia Rating - Global Score (CDR-GS) will be used to assess disease severity at baseline and evaluated as a predictor of treatment efficacy and examined for associations with differential treatment response. The CDR-SB assesses cognitive and functional impairment across six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Global scores range from 0 to 3, with higher scores indicating greater impairment.
Measured: Baseline
Level of Education and Occupational Attainment as Proxies of Cognitive Reserve
Level of education and occupational attainment will be assessed at baseline as proxy measures of cognitive reserve and examined for associations with differential treatment response.
Measured: Baseline
Plasma Biomarker Profile
The plasma biomarker profile will be evaluated as a predictor of treatment efficacy and examined for associations with differential treatment response.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 2026Sep 2032

First posted24 Sep 2026
Study start16 Sep 2026 (estimated)
Primary completionSep 2031 (estimated)
Study completionSep 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (32)Papers the sponsor has linked to this study.
Other trials for Transcranial Alternating Current StimulationStudies 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, Care provider, Outcomes assessor
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07839650
Sponsor's protocol ID: AD_tACSrehab
Acronym: AD_tACSrehab
Status last verified: Sep 2026
First submitted: 14 Sep 2026
Last updated: 24 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Clare L, Wilson BA, Carter G, Hodges JR, Adams M. (2001). Long-term maintenance of treatment gains following a cognitive rehabilitation intervention in early dementia of Alzheimer type: a single case study. Neuropsychological Rehabilitation. 11:477-494. doi: 10.1080/09602010042000213
Clare L, Wilson BA, Breen K, Hodges JR. (1999). Errorless learning of face-name associations in early Alzheimer's disease. Neurocase. 5:37-46. doi: 10.1080/13554799908404063
Williams MM, Storandt M, Roe CM, Morris JC. Progression of Alzheimer's disease as measured by Clinical Dementia Rating Sum of Boxes scores. Alzheimers Dement. 2013 Feb;9(1 Suppl):S39-44. doi: 10.1016/j.jalz.2012.01.005. Epub 2012 Aug 1.
PubMed 22858530
Verma N, Beretvas SN, Pascual B, Masdeu JC, Markey MK; Alzheimer's Disease Neuroimaging Initiative. New scoring methodology improves the sensitivity of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) in clinical trials. Alzheimers Res Ther. 2015 Nov 12;7(1):64. doi: 10.1186/s13195-015-0151-0.
PubMed 26560146
Tokimura H, Di Lazzaro V, Tokimura Y, Oliviero A, Profice P, Insola A, Mazzone P, Tonali P, Rothwell JC. Short latency inhibition of human hand motor cortex by somatosensory input from the hand. J Physiol. 2000 Mar 1;523 Pt 2(Pt 2):503-13. doi: 10.1111/j.1469-7793.2000.t01-1-00503.x.
PubMed 10699092
Rentz DM, Amariglio RE, Becker JA, Frey M, Olson LE, Frishe K, Carmasin J, Maye JE, Johnson KA, Sperling RA. Face-name associative memory performance is related to amyloid burden in normal elderly. Neuropsychologia. 2011 Jul;49(9):2776-83. doi: 10.1016/j.neuropsychologia.2011.06.006. Epub 2011 Jun 12.
PubMed 21689670
Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
PubMed 20633386
McCue M, Fairman A, Pramuka M. Enhancing quality of life through telerehabilitation. Phys Med Rehabil Clin N Am. 2010 Feb;21(1):195-205. doi: 10.1016/j.pmr.2009.07.005.
PubMed 19951786
Massimini M, Ferrarelli F, Huber R, Esser SK, Singh H, Tononi G. Breakdown of cortical effective connectivity during sleep. Science. 2005 Sep 30;309(5744):2228-32. doi: 10.1126/science.1117256.
PubMed 16195466
Kujirai T, Caramia MD, Rothwell JC, Day BL, Thompson PD, Ferbert A, Wroe S, Asselman P, Marsden CD. Corticocortical inhibition in human motor cortex. J Physiol. 1993 Nov;471:501-19. doi: 10.1113/jphysiol.1993.sp019912.
PubMed 8120818
Hoy KE, Bailey N, Arnold S, Windsor K, John J, Daskalakis ZJ, Fitzgerald PB. The effect of gamma-tACS on working memory performance in healthy controls. Brain Cogn. 2015 Dec;101:51-6. doi: 10.1016/j.bandc.2015.11.002. Epub 2015 Nov 12.
PubMed 26580743
Herrmann CS, Rach S, Neuling T, Struber D. Transcranial alternating current stimulation: a review of the underlying mechanisms and modulation of cognitive processes. Front Hum Neurosci. 2013 Jun 14;7:279. doi: 10.3389/fnhum.2013.00279. eCollection 2013.
PubMed 23785325
Hajos M, Boasso A, Hempel E, Shpokayte M, Konisky A, Seshagiri CV, Fomenko V, Kwan K, Nicodemus-Johnson J, Hendrix S, Vaughan B, Kern R, Megerian JT, Malchano Z. Safety, tolerability, and efficacy estimate of evoked gamma oscillation in mild to moderate Alzheimer's disease. Front Neurol. 2024 Mar 6;15:1343588. doi: 10.3389/fneur.2024.1343588. eCollection 2024.
PubMed 38515445
Galasko D, Bennett D, Sano M, Ernesto C, Thomas R, Grundman M, Ferris S. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S33-9.
PubMed 9236950
Davis RN, Massman PJ, Doody RS. Cognitive intervention in Alzheimer disease: a randomized placebo-controlled study. Alzheimer Dis Assoc Disord. 2001 Jan-Mar;15(1):1-9. doi: 10.1097/00002093-200101000-00001.
PubMed 11236819

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interventional Study to Evaluate the Effectiveness of Transcranial Alternating Current Stimulation (tACS) Combined With Cognitive Training on Cognitive Performance in Patients With Alzheimer's Disease
ClinicalTrials.gov ID: NCT07839650
Acronym / sponsor ID: AD_tACSrehab / AD_tACSrehab
Conditions: Transcranial Alternating Current Stimulation, Alzheimer Disease (AD), Alzheimer Dementia (AD), Cognitive Rehabilitation
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
Study start: 16 Sep 2026 (estimated)
Primary completion: Sep 2031 (estimated)
Study completion: Sep 2032 (estimated)
First posted: 24 Sep 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Real tACS	Experimental	Device: Transcranial Alternating Current Stimulation, Behavioral: Individualized Computerized Memory Training
Sham tACS	Sham comparator	Device: Sham Transcranial Alternating Current Stimulation, Behavioral: Individualized Computerized Memory Training

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male or female participants aged ≥18 years at the time of signing the informed consent form;
Clinical diagnosis of mild Alzheimer's disease (AD) according to current clinical criteria;
Availability of a caregiver who can assist the participant and who has successfully completed the required training for the use of the device at home.
Male or female caregivers aged ≥18 years;
Compliance with participation in the in-hospital training;

Key exclusion criteria (3 listed)

Age below that specified in the inclusion criteria;
Inability to understand;
Contraindications to tACS and TMS (e.g., presence of a cardiac pacemaker or metallic implants incompatible with electrical or magnetic fields, history of epilepsy, or current pregnancy, as assessed using the safety questionnaire).

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
Transcranial Alternating Current Stimulation40 at-home sessions (5 days/week for 8 weeks), each consisting of the application of tACS (real, 40 Hz) applied over the precuneus for a duration of 60 minutes each.	Device	Real tACS
Sham Transcranial Alternating Current Stimulation40 at-home sessions (5 days/week for 8 weeks), each consisting of the application of sham tACS applied over the precuneus for a duration of 60 minutes each. The electrode placement will be identical to that used for real stimulation. However, the electrical current will be automatically interrupted approximately 5 seconds after the start of stimulation, making it impossible for the participant to distinguish between sham and real stimulation.	Device	Sham tACS
Individualized Computerized Memory TrainingParticipants will receive individualized computerized memory training for 8 weeks (2 sessions/week, 30 minutes/session) through synchronous telerehabilitation. The memory training will be individualized based on each participant's performance on the Face-Name Association Task (FNAT) and will use an errorless learning approach.	Behavioural	Real tACS, Sham tACS

Primary outcome

Mini-Mental State Examination (MMSE)
Time frame: Change from baseline to week 24
The global cognitive functioning will be assessed by Mini-Mental State Examination (MMSE); MMSE scores range from 0 to 30, with higher scores indicating a more preserved cognition.
Semantic Fluency Test
Time frame: Change from baseline to week 8, 16, and 24
Lexical-semantic access and executive functioning will be evaluated by Semantic Fluency Test. Participant is asked to generate as many words as possible from a given category within a limited time (60 seconds); higher scores indicate better performance.
Trail Making Test (TMT - A, B)
Time frame: Change from baseline to week 8, 16, and 24
Executive function will be assessed using the Trail Making Test, including Part A (visual attention and processing speed) and Part B (task switching and cognitive flexibility). Higher completion times reflect poorer performance.
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Change from baseline to week 8, 16 and 24
Verbal memory will be assessed using the Rey Auditory Verbal Learning Test (RAVLT), including immediate recall (sum of trials), delayed recall after 15 minutes. Scores reflect the number of correctly recalled items.
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-13)
Time frame: Change from baseline to week 8, 16 and 24
The ADAS-Cog-13 consists of 13 tasks assessing cognitive domains including memory, language, praxis, orientation, and attention. Total scores range from 0 to 85, with higher scores indicating greater cognitive impairment.
Face-Name Associative Memory Test (FNAT)
Time frame: Change from baseline to week 8, 16 and 24
The Face-Name Associative Memory Test is used to assess the participant's associative memory and is composed of encoding and retrieval phases, with higher scores indicating better function.
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time frame: Change from baseline to week 8, 16 and 24
ADCS-ADL evaluates activities of daily living. The scores range from 0-78 with lower scores indicating more severe functional impairment.
Neuropsychiatric Inventory (NPI)
Time frame: Change from baseline to week 8, 16 and 24
Neuropsychiatric Inventory (NPI) is designed to be a structured clinical interview about neuropsychiatric and behavioral symptoms; the score ranges from 0 (no symptoms) to 144 (severe symptoms).
Clinical Dementia Rating scale - Sum of Boxes (CDR-SoB)
Time frame: Change from baseline to week 8, 16 and 24
The Clinical Dementia Rating-Sum of Boxes (CDR-SB) assesses cognitive and functional impairment across six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Total scores range from 0 to 18, with higher scores indicating greater cognitive and functional impairment.
Clinical Dementia Rating scale - Global Score (CDR-GS)
Time frame: Change from baseline to week 8, 16 and 24
The Clinical Dementia Rating Global Score (CDR-GS) assesses the overall severity of cognitive and functional impairment across six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Global scores range from 0 to 3, with higher scores indicating greater impairment.
Zarit Burden Interview (ZBI)
Time frame: Change from baseline to week 8, 16, and 24
The Zarit Burden Interview (ZBI) assesses the perceived burden experienced by caregivers of individuals with dementia. It consists of 22 items rated on a 5-point scale. Total scores range from 0 to 88, with higher scores indicating greater caregiver burden.

7 secondary outcomes

Change in SAI measurements
Time frame: Change from baseline to week 8, 16, and 24
Change From Baseline in Biological Marker Concentrations
Time frame: Change from baseline to week 8, 16, and 24
Demographic characteristics
Time frame: Baseline
Baseline Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Time frame: Baseline
Baseline Clinical Dementia Rating - Global Score (CDR-GS)
Time frame: Baseline
Level of Education and Occupational Attainment as Proxies of Cognitive Reserve
Time frame: Baseline
Plasma Biomarker Profile
Time frame: Baseline

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 24 Sep 2026.
BackgroundClare L, Wilson BA, Carter G, Hodges JR, Adams M. (2001). Long-term maintenance of treatment gains following a cognitive rehabilitation intervention in early dementia of Alzheimer type: a single case study. Neuropsychological Rehabilitation. 11:477-494. doi: 10.1080/09602010042000213
BackgroundClare L, Wilson BA, Breen K, Hodges JR. (1999). Errorless learning of face-name associations in early Alzheimer's disease. Neurocase. 5:37-46. doi: 10.1080/13554799908404063
Background: PubMed 22858530Williams MM, Storandt M, Roe CM, Morris JC. Progression of Alzheimer's disease as measured by Clinical Dementia Rating Sum of Boxes scores. Alzheimers Dement. 2013 Feb;9(1 Suppl):S39-44. doi: 10.1016/j.jalz.2012.01.005. Epub 2012 Aug 1.
Background: PubMed 26560146Verma N, Beretvas SN, Pascual B, Masdeu JC, Markey MK; Alzheimer's Disease Neuroimaging Initiative. New scoring methodology improves the sensitivity of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) in clinical trials. Alzheimers Res Ther. 2015 Nov 12;7(1):64. doi: 10.1186/s13195-015-0151-0.
Background: PubMed 10699092Tokimura H, Di Lazzaro V, Tokimura Y, Oliviero A, Profice P, Insola A, Mazzone P, Tonali P, Rothwell JC. Short latency inhibition of human hand motor cortex by somatosensory input from the hand. J Physiol. 2000 Mar 1;523 Pt 2(Pt 2):503-13. doi: 10.1111/j.1469-7793.2000.t01-1-00503.x.
Background: PubMed 21689670Rentz DM, Amariglio RE, Becker JA, Frey M, Olson LE, Frishe K, Carmasin J, Maye JE, Johnson KA, Sperling RA. Face-name associative memory performance is related to amyloid burden in normal elderly. Neuropsychologia. 2011 Jul;49(9):2776-83. doi: 10.1016/j.neuropsychologia.2011.06.006. Epub 2011 Jun 12.
Background: PubMed 20633386Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
Background: PubMed 19951786McCue M, Fairman A, Pramuka M. Enhancing quality of life through telerehabilitation. Phys Med Rehabil Clin N Am. 2010 Feb;21(1):195-205. doi: 10.1016/j.pmr.2009.07.005.
Background: PubMed 16195466Massimini M, Ferrarelli F, Huber R, Esser SK, Singh H, Tononi G. Breakdown of cortical effective connectivity during sleep. Science. 2005 Sep 30;309(5744):2228-32. doi: 10.1126/science.1117256.
Background: PubMed 8120818Kujirai T, Caramia MD, Rothwell JC, Day BL, Thompson PD, Ferbert A, Wroe S, Asselman P, Marsden CD. Corticocortical inhibition in human motor cortex. J Physiol. 1993 Nov;471:501-19. doi: 10.1113/jphysiol.1993.sp019912.
Background: PubMed 26580743Hoy KE, Bailey N, Arnold S, Windsor K, John J, Daskalakis ZJ, Fitzgerald PB. The effect of gamma-tACS on working memory performance in healthy controls. Brain Cogn. 2015 Dec;101:51-6. doi: 10.1016/j.bandc.2015.11.002. Epub 2015 Nov 12.
Background: PubMed 23785325Herrmann CS, Rach S, Neuling T, Struber D. Transcranial alternating current stimulation: a review of the underlying mechanisms and modulation of cognitive processes. Front Hum Neurosci. 2013 Jun 14;7:279. doi: 10.3389/fnhum.2013.00279. eCollection 2013.

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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.

IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli

Brescia, Italy

+39 0303501358

bborroni@fatebenefratelli.eu

IRCCS S. Maria Nascente - Fondazione Don Carlo Gnocchi

Milan, Italy

+390240308951

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mini-Mental State Examination (MMSE) (time frame: Change from baseline to week 24). The study lists 11 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 NCT07839650, which also lists 32 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 24 Sep 2026.