Alzheimer DiseaseNICE-ADNCT04404153
Neurostimulation for Cognitive Enhancement in Alzheimer's Disease
A study testing tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS. in people with Alzheimer Disease and Dementia, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
The prevalence of Alzheimer's Disease (AD) is rising, but existing medications provide only modest control of cognitive decline and associated symptoms, and novel therapies are urgently needed. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2021to 19 Feb 2026
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community-dwelling male or female of age 60 and older
- AD diagnosed by neurologists or geriatricians at our dementia and geriatric clinical sites. Clinicians will review the medical records of all potential cases to ensure the patients meet established clinical criteria for AD, and also examine individuals as needed to further establish the diagnosis. Mild-to moderate stage AD as determined by study clinicians using the Clinical Dementia Rating Scale (CDR). The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to AD: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care. The necessary information to make each rating is obtained through a semi-structured interview of the patient and a reliable informant (e.g., family member). A CDR score of 0.5 or 1 is rated as mild severity and a score of 2 is rated as moderate severity. The investigators selected mild to moderate AD patients as our target population as they are the most prevalent AD severity group referred to our clinics, increasing generalizability. This mild to moderate AD group is also most likely to be cared for in the community and at home, in contrast to more advanced or severe AD stages, which are more prevalent in institutional settings (and will be the focus of our future studies)
- If on dementia medication regimen, the regimen is stable for at least 4 weeks prior to enrollment. The investigators will not restrict clinicians from starting, adjusting or stopping dementia medications over the intervention period in keeping with the pragmatic nature of our trial, but will account for medications in both groups in our analysis
- Able to speak and understand English or Spanish at a level sufficient undergo the study procedures and testing protocols
- Willing to complete an MRI (exclusions relevant to neuroimaging are described below)
- Able to provide Informed Consent (or able to provide assent with a legal surrogate providing informed consent.)
Who cannot join
- Unstable medical or major psychiatric illnesses or unstable treatments for medical or major psychiatric illnesses. Any medical or psychiatric diagnosis is permitted as long as it has been clinically stable for at least 3 months, reflected in part by stability of treatments for at least 3 months, and is expected on the basis of clinical judgment to be in a stable phase that will likely extend for 6 months
- History of head trauma, seizures, brain surgery, stroke or cancer affecting head, metal implants in the head or neck, compromised integrity or sensitivity of the skin at or near locations where electrodes will be placed (e.g., eczema, severe rashes, blisters, open wounds, burn including sunburns, cuts or irritation)
- Currently participating in another intervention study or using neurostimulation device
- Exclusions specific to neuroimaging procedure: the presence of any surgically implanted metallic devices, such as aneurysm clips or pacemakers that would be a safety contraindication for MRI. Subjects with large amounts of dental or surgical hardware in the head and neck will be excluded because magnetic susceptibility effects will lead to severe image artifacts in these subjects' images. Due to the confined space of the MRI magnet, subjects with a known history of claustrophobia will also be excluded as will subjects with weight >350lbs or waist circumference >55 inches
- Must not be currently receiving or have received (or completed) within the past 3 months any monoclonal antibody treatment for Alzheimer's
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Non-Invasive Home Neurostimulation for Mild to Moderate Alzheimer's Disease: Double-Blind, Sham Controlled Randomized Clinical Trial
The prevalence of Alzheimer's Disease (AD) is rising, but existing medications provide only modest control of cognitive decline and associated symptoms, and novel therapies are urgently needed. This randomized sham-controlled trial will determine if an innovative low-risk remotely-supervised transcranial Direct Current Stimulation (tDCS) applied over the area of the dorsolateral prefrontal cortex for 30 minutes at the intensity of 2 mA five times per week for 6 months at home can improve cognitive performance and symptoms and modulate neuroimaging markers of neuroplasticity in 100 patients with mild to moderate AD. If effective, this novel intervention can substantially enhance AD symptom management at home, improve quality of life of AD patients and their families, and reduce burden associated with this debilitating illness.
Read the detailed description
The hallmark of Alzheimer's Disease (AD) is cognitive decline with varied associated symptoms and signs. Unfortunately, there is no cure as yet for AD. Available treatments, including 5 FDA-approved medications, have limited efficacy in terms of slowing pathological progression or controlling the symptoms and signs of cognitive decline in AD patients. Given the high burdens and costs of AD, and the therapeutic limitations, the development of novel treatment approaches for AD is of the highest importance for patients, families, medical providers, and society. This randomized controlled trial will determine if innovative, low-risk neurostimulation at home for 6 months can improve cognitive performance and symptoms in patients with mild to moderate AD.
The primary objective is to determine the effects produced by 6 months of active tDCS or sham delivered over dorsolateral prefrontal cortex (DLPFC) in home settings on global cognitive performance (assessed by ADAS-Cog test - primary outcome), and secondarily on executive control/spatial selective attention (Eriksen Flanker Test), depressed mood (Geriatric depression scale), quality of life (Quality of Life Questionnaire-Alzheimer's Disease), and patient satisfaction with both the device and procedure (Neurostimulation User's Survey), in mild-to-moderate AD patients (n=100). The investigators also aim to determine functional and structural brain connectivity/network changes in response to the study intervention using functional Magnetic Resonance Imaging (fMRI; during rest and during executive function tasks), diffusion-weighted imaging (DWI), and multivariate covariance-based analytic approaches. Lastly, the investigators aim to examine time characteristics (durability) of the tDCS behavioral and neuroplasticity effects for up to 3 months following the intervention period.
The intervention will consist of remotely supervised active tDCS stimulation and sham tDCS stimulation over the area of the dorsolateral prefrontal cortex, applied at home for 30 minutes 5 times per week for 6 months. Participants randomized to the active tDCS will receive at each application 30 minutes of direct current stimulation at the intensity of 2 mA. Participants randomized to the sham group will receive sham tDCS which consists of current ramped up to 2mA over 30 seconds, ramped down over 30 seconds and stay at 0 current for the remaining time of the 30-minute application.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS., tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver sham tDCS.
- Keywords
- Alzheimer's Disease, transcranial direct current stimulation (tDCS)
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS.Device
At-home remotely supervised tDCS delivered over the dorsolateral prefrontal cortex with the anode on the left, cathode on the right, at an intensity of 2 mA, delivered for 30 minutes five times per week (Monday-Friday) for 26 weeks (6 months).
tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver sham tDCS.Device
Sham treatment will consist of the current ramped up to 2mA over 30 seconds, ramped down over 30 seconds and stay at 0 current for the remaining time of the 30-minute application period five times per week (Monday-Friday) for 26 weeks (6 months).
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | The active tDCS will involve 30-minutes of direct current at intensity of 2 milliamperes (mA). Receives: Device: tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS. |
| Sham tDCS | Sham comparator | Sham stimulation consists of the direct current ramped up to 2mA over 30 seconds, ramped down over 30 seconds and stay at 0 current for the remaining application period. Receives: Device: tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver sham tDCS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Cognitive Performance
Change in The Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) was developed as an outcome measure for dementia interventions; its primary purpose was to be an index of global cognition in response to therapies. It assesses multiple cognitive domains across 11 items: Word Recall Task, Naming Objects and Fingers, Following Commands, Constructional Praxis, Ideational Praxis, Orientation, Word Recognition Task, Remembering Test Directions, Spoken Language, Comprehension and Word-Finding Difficulty. The score ranges from 0 to 70. A 4-point ADAS-cog change at 6 months is clinically meaningful.
Measured: Baseline, at 6 months (immediately after the 6-month intervention)
Functional Neuroplasticity-Digit Symbol Substitution
The investigators will examine intervention-related changes in functional activation/deactivation networks during Digit Symbol Substitution Test. The investigators predict tDCS-related changes in functional/deactivation relative to sham - particularly in dorsolateral prefrontal cortex and associated networks.
Measured: Baseline, at 6 months (immediately after the 6-month intervention) and 9-months (3 months post-intervention).
Functional Neuroplasticity - Flanker Interference Task
The investigators will examine intervention-related changes in functional activation/deactivation networks during Flanker tests. The investigators predict tDCS-related changes in functional/deactivation relative to sham - particularly in dorsolateral prefrontal cortex and associated networks.
Measured: Baseline, at 6 months (immediately after the 6-month intervention) and 9-months (3 months post-intervention).
Secondary outcomes (6)
Multiple-Domain Cognitive Dysfunction
The Digit Symbol Substitution Test (a subtest of the Wechsler Adult Intelligence Scale - Revised) is a measure of attention, transcription and speed of processing. Scoring is based on the total number of correct responses generated during a 90-sec time interval. Higher values reflect better outcome.
Measured: Baseline, at 6 months (immediately after the 6-month intervention), at 7 months (1 month post-intervention) and 9-months (3 months post-intervention).
Executive control/spatial selective attention
The Flanker Test is a measure of speed of processing, attention and inhibitory control. Scoring is based on accuracy and reaction time. Lower values reflect better outcome.
Measured: Baseline, at 6 months (immediately after the 6-month intervention), at 7 months (1 month post-intervention) and 9-months (3 months post-intervention).
Quality of Life Scale
The Quality of Life - Alzheimer's Disease, self-reported includes 13 items representing physical, social and psychological well-being. Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better quality of life. The administration takes about 5 minutes.
Measured: Baseline, at 6 months (immediately after the 6-month intervention), at 7 months (1 month post-intervention) and 9-months (3 months post-intervention).
Depressive Symptoms
Changes in depressive symptoms assessed using the 15 item Geriatric Depression Scale, scores range from 0 (not depressed) to 15 (depressed).
Measured: Baseline, at 6 months (immediately after the 6-month intervention), at 7 months (1 month post-intervention) and 9-months (3 months post-intervention).
Tolerability of the study intervention: number of side effects and adverse events
Determined as number of side effects and adverse events related, probably related or possibly related to the study intervention.
Measured: Baseline, at 6 months (immediately after the 6-month intervention), at 7 months (1 month post-intervention) and 9-months (3 months post-intervention).
Patient's satisfaction: 8-item tDCS User Survey
Patient's satisfaction with the study intervention determined from the 8-item tDCS User Survey at the end of the intervention. Each item of the Survey is a brief statement and a respondent indicates if s/he Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree with the statement. Higher number of Agree/Strongly Agree ratings reflects higher satisfaction with the tDCS procedure.
Measured: Baseline, at 6 months (immediately after the 6-month intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start25 Mar 2021
- Primary completion28 Oct 2025
- Study completion19 Feb 2026
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- MJHS Institute for Innovation in Palliative Care, Stony Brook University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Joe Verghese, MD, Principal investigator, Stony Brook UniversityLara Dhingra, PhD, Principal investigator, Metropolitan Jewish Health SystemMirnova Ceide, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404153
- Sponsor's protocol ID
- 2020-11274
- Other IDs
- R01AG068167
- Acronym
- NICE-AD
- Status last verified
- Sep 2026
- First submitted
- 22 May 2020
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gulley E, Verghese J, Blumen HM, Ayers E, Wang C, Portenoy RK, Zwerling JL, Weiss E, Knotkova H. Neurostimulation for cognitive enhancement in Alzheimer's disease (the NICE-AD study): a randomized clinical trial. Neurodegener Dis Manag. 2021 Aug;11(4):277-288. doi: 10.2217/nmt-2020-0061. Epub 2021 Jul 9.
PubMed 34240627
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Home Neurostimulation for Mild to Moderate Alzheimer's Disease: Double-Blind, Sham Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04404153
- Acronym / sponsor ID
- NICE-AD / 2020-11274
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- Alzheimer's Disease, transcranial direct current stimulation (tDCS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- MJHS Institute for Innovation in Palliative Care, Stony Brook University, National Institute on Aging (NIA)
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 27 May 2020 (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.
The prevalence of Alzheimer's Disease (AD) is rising, but existing medications provide only modest control of cognitive decline and associated symptoms, and novel therapies are urgently needed. This randomized sham-controlled trial will determine if an innovative low-risk remotely-supervised transcranial Direct Current Stimulation (tDCS) applied over the area of the dorsolateral prefrontal cortex for 30 minutes at the intensity of 2 mA five times per week for 6 months at home can improve cognitive performance and symptoms and modulate neuroimaging markers of neuroplasticity in 100 patients with mild to moderate AD. If effective, this novel intervention can substantially enhance AD symptom management at home, improve quality of life of AD patients and their families, and reduce burden associated with this debilitating illness.
Detailed description
The hallmark of Alzheimer's Disease (AD) is cognitive decline with varied associated symptoms and signs. Unfortunately, there is no cure as yet for AD. Available treatments, including 5 FDA-approved medications, have limited efficacy in terms of slowing pathological progression or controlling the symptoms and signs of cognitive decline in AD patients. Given the high burdens and costs of AD, and the therapeutic limitations, the development of novel treatment approaches for AD is of the highest importance for patients, families, medical providers, and society. This randomized controlled trial will determine if innovative, low-risk neurostimulation at home for 6 months can improve cognitive performance and symptoms in patients with mild to moderate AD.
The primary objective is to determine the effects produced by 6 months of active tDCS or sham delivered over dorsolateral prefrontal cortex (DLPFC) in home settings on global cognitive performance (assessed by ADAS-Cog test - primary outcome), and secondarily on executive control/spatial selective attention (Eriksen Flanker Test), depressed mood (Geriatric depression scale), quality of life (Quality of Life Questionnaire-Alzheimer's Disease), and patient satisfaction with both the device and procedure (Neurostimulation User's Survey), in mild-to-moderate AD patients (n=100). The investigators also aim to determine functional and structural brain connectivity/network changes in response to the study intervention using functional Magnetic Resonance Imaging (fMRI; during rest and during executive function tasks), diffusion-weighted imaging (DWI), and multivariate covariance-based analytic approaches. Lastly, the investigators aim to examine time characteristics (durability) of the tDCS behavioral and neuroplasticity effects for up to 3 months following the intervention period.
The intervention will consist of remotely supervised active tDCS stimulation and sham tDCS stimulation over the area of the dorsolateral prefrontal cortex, applied at home for 30 minutes 5 times per week for 6 months. Participants randomized to the active tDCS will receive at each application 30 minutes of direct current stimulation at the intensity of 2 mA. Participants randomized to the sham group will receive sham tDCS which consists of current ramped up to 2mA over 30 seconds, ramped down over 30 seconds and stay at 0 current for the remaining time of the 30-minute application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS.The active tDCS will involve 30-minutes of direct current at intensity of 2 milliamperes (mA). |
| Sham tDCS | Sham comparator | Device: tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver sham tDCS.Sham stimulation consists of the direct current ramped up to 2mA over 30 seconds, ramped down over 30 seconds and stay at 0 current for the remaining application period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Community-dwelling male or female of age 60 and older
- AD diagnosed by neurologists or geriatricians at our dementia and geriatric clinical sites. Clinicians will review the medical records of all potential cases to ensure the patients meet established clinical criteria for AD, and also examine individuals as needed to further establish the diagnosis. Mild-to moderate stage AD as determined by study clinicians using the Clinical Dementia Rating Scale (CDR). The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to AD: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care. The necessary information to make each rating is obtained through a semi-structured interview of the patient and a reliable informant (e.g., family member). A CDR score of 0.5 or 1 is rated as mild severity and a score of 2 is rated as moderate severity. The investigators selected mild to moderate AD patients as our target population as they are the most prevalent AD severity group referred to our clinics, increasing generalizability. This mild to moderate AD group is also most likely to be cared for in the community and at home, in contrast to more advanced or severe AD stages, which are more prevalent in institutional settings (and will be the focus of our future studies)
- If on dementia medication regimen, the regimen is stable for at least 4 weeks prior to enrollment. The investigators will not restrict clinicians from starting, adjusting or stopping dementia medications over the intervention period in keeping with the pragmatic nature of our trial, but will account for medications in both groups in our analysis
- Able to speak and understand English or Spanish at a level sufficient undergo the study procedures and testing protocols
- Willing to complete an MRI (exclusions relevant to neuroimaging are described below)
Key exclusion criteria (5 listed)
- Unstable medical or major psychiatric illnesses or unstable treatments for medical or major psychiatric illnesses. Any medical or psychiatric diagnosis is permitted as long as it has been clinically stable for at least 3 months, reflected in part by stability of treatments for at least 3 months, and is expected on the basis of clinical judgment to be in a stable phase that will likely extend for 6 months
- History of head trauma, seizures, brain surgery, stroke or cancer affecting head, metal implants in the head or neck, compromised integrity or sensitivity of the skin at or near locations where electrodes will be placed (e.g., eczema, severe rashes, blisters, open wounds, burn including sunburns, cuts or irritation)
- Currently participating in another intervention study or using neurostimulation device
- Exclusions specific to neuroimaging procedure: the presence of any surgically implanted metallic devices, such as aneurysm clips or pacemakers that would be a safety contraindication for MRI. Subjects with large amounts of dental or surgical hardware in the head and neck will be excluded because magnetic susceptibility effects will lead to severe image artifacts in these subjects' images. Due to the confined space of the MRI magnet, subjects with a known history of claustrophobia will also be excluded as will subjects with weight >350lbs or waist circumference >55 inches
- Must not be currently receiving or have received (or completed) within the past 3 months any monoclonal antibody treatment for Alzheimer's
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 device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS.At-home remotely supervised tDCS delivered over the dorsolateral prefrontal cortex with the anode on the left, cathode on the right, at an intensity of 2 mA, delivered for 30 minutes five times per week (Monday-Friday) for 26 weeks (6 months). | Device | Active tDCS |
| tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver sham tDCS.Sham treatment will consist of the current ramped up to 2mA over 30 seconds, ramped down over 30 seconds and stay at 0 current for the remaining time of the 30-minute application period five times per week (Monday-Friday) for 26 weeks (6 months). | Device | Sham tDCS |
Primary outcome
Global Cognitive Performance
Time frame: Baseline, at 6 months (immediately after the 6-month intervention)
Change in The Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) was developed as an outcome measure for dementia interventions; its primary purpose was to be an index of global cognition in response to therapies. It assesses multiple cognitive domains across 11 items: Word Recall Task, Naming Objects and Fingers, Following Commands, Constructional Praxis, Ideational Praxis, Orientation, Word Recognition Task, Remembering Test Directions, Spoken Language, Comprehension and Word-Finding Difficulty. The score ranges from 0 to 70. A 4-point ADAS-cog change at 6 months is clinically meaningful.
Functional Neuroplasticity-Digit Symbol Substitution
Time frame: Baseline, at 6 months (immediately after the 6-month intervention) and 9-months (3 months post-intervention).
The investigators will examine intervention-related changes in functional activation/deactivation networks during Digit Symbol Substitution Test. The investigators predict tDCS-related changes in functional/deactivation relative to sham - particularly in dorsolateral prefrontal cortex and associated networks.
Functional Neuroplasticity - Flanker Interference Task
Time frame: Baseline, at 6 months (immediately after the 6-month intervention) and 9-months (3 months post-intervention).
The investigators will examine intervention-related changes in functional activation/deactivation networks during Flanker tests. The investigators predict tDCS-related changes in functional/deactivation relative to sham - particularly in dorsolateral prefrontal cortex and associated networks.
6 secondary outcomes
Multiple-Domain Cognitive Dysfunction
Time frame: Baseline, at 6 months (immediately after the 6-month intervention), at 7 months (1 month post-intervention) and 9-months (3 months post-intervention).
Executive control/spatial selective attention
Time frame: Baseline, at 6 months (immediately after the 6-month intervention), at 7 months (1 month post-intervention) and 9-months (3 months post-intervention).
Quality of Life Scale
Time frame: Baseline, at 6 months (immediately after the 6-month intervention), at 7 months (1 month post-intervention) and 9-months (3 months post-intervention).
Depressive Symptoms
Time frame: Baseline, at 6 months (immediately after the 6-month intervention), at 7 months (1 month post-intervention) and 9-months (3 months post-intervention).
Tolerability of the study intervention: number of side effects and adverse events
Time frame: Baseline, at 6 months (immediately after the 6-month intervention), at 7 months (1 month post-intervention) and 9-months (3 months post-intervention).
Patient's satisfaction: 8-item tDCS User Survey
Time frame: Baseline, at 6 months (immediately after the 6-month intervention)
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 22 Sep 2026.
- Background: PubMed 34240627Gulley E, Verghese J, Blumen HM, Ayers E, Wang C, Portenoy RK, Zwerling JL, Weiss E, Knotkova H. Neurostimulation for cognitive enhancement in Alzheimer's disease (the NICE-AD study): a randomized clinical trial. Neurodegener Dis Manag. 2021 Aug;11(4):277-288. doi: 10.2217/nmt-2020-0061. Epub 2021 Jul 9.
- 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.
Joe Verghese, MD principal investigator
Stony Brook University
Lara Dhingra, PhD principal investigator
Metropolitan Jewish Health System
Mirnova Ceide, MD principal investigator
Albert Einstein College of Medicine
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 device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS. in people with Alzheimer Disease and Dementia, run by Albert Einstein College of Medicine at 1 site in United States.
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 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 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 1 site in United States. 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?
Global Cognitive Performance (time frame: Baseline, at 6 months (immediately after the 6-month intervention)). 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 NCT04404153, 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 22 Sep 2026.