Transcranial Alternating Current StimulationNCT06565143
Effect of Transcranial Alternating Current Stimulation(tACS) for Early Alzheimer's Disease
A study testing Transcranial alternating current stimulation in people with Transcranial Alternating Current Stimulation and Electroencephalography, run by Anhui Medical University at 1 site in China.
Trial summary
To investigate the clinical effect neural mechanism of transcranial alternating current stimulation in early Alzheimer's disease Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Transcranial Alternating Current Stimulation, Electroencephalography, Early Alzheimer's Disease
- What is being tested?
- Transcranial alternating current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Jul 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject diagnosed with early Alzheimer's disease or related diseases according to NIA-AA criteria.
- Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia.
- CDR score ≤ 2.
- Subject under treatment by IAChE for at least 3 months.
- psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months.
Who cannot join
- CDR > 2
- Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
- History of head injury,stroke,or other neurologic disease.
- Organic brain defects on T1 or T2 images.
- History of seizures or unexplained loss of consciousness.
- Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.
- Family history of medication refractory epilepsy.
- History of substance abuse within the last 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Medical University
Hefei, Anhui, 230032
Xingqi Wu, M.D., +8618788836237 ext. +86, wuxingqi09@163.com
Miao Fang, +8617778381505 ext. +86, fangmiao9511@163.com
About this study
To investigate the clinical effect neural mechanism of transcranial alternating current stimulation in early Alzheimer's disease
Read the detailed description
Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and tACS at the First Affiliated Hospital of Anhui medical university. Patients were randomly allocated to tACS group and the sham group. There are about 20 patients in each group. For the all patients, allocation was by coin toss. Patients were studied using a double-blind design. Study participants and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only tACS administrators had access to the randomization list; they had minimal contact with the patients, and no role in cognitive and symptom assessments. Each patient would be treated for continuous 14 days by tACS.
Before the tACS treatment, a series of cognitive assessments and neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) as the primary outcome measure and various other tasks and questionnaires to measure cognition (including MoCA,MMSE, DS, Stroop test, TMT, BNT-30, VFT, CDT,JLOT. Form H,HVOT), memory (CAVLT, LMT), emotion(HAMA-17,HAMD-14,GDS-30), behavioral and psychological symptoms(NPI), and treatment tolerability. All the tests are conducted in two days. The patient received resting EEG data collection. After the last treatment, the MoCA, and associative memory were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, resting EEG. Two months after the last treatment, participants were interviewed to obtain the same assessment as before. They were instructed to focus their answers on the past months.
- Conditions
- Transcranial Alternating Current Stimulation, Electroencephalography, Early Alzheimer's Disease
- Being tested
- Transcranial alternating current stimulation, Sham transcranial alternating current stimulation
- Keywords
- Transcranial Alternating Current Stimulation, Electroencephalography, Neuropsychology, Early Alzheimer's Disease, Alzheimer's Disease Assessment Scale-Cognitive Subscale, Working Memory
- 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
Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation tool that alters cortical excitability and activity via application of weak alternating currents.
Sham transcranial alternating current stimulationDevice
In the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (30s); no current was delivered during the 30-minute intervention.
| Study group | Role | What they receive |
|---|---|---|
| transcranial alternating current stimulation-Real | Active comparator | Participants will receive real tACS once daily for 14 days Receives: Device: Transcranial alternating current stimulation |
| transcranial alternating current stimulation-Sham | Sham comparator | Participants will receive sham tACS once daily for 14 days Receives: Device: Sham transcranial alternating current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)
The changes in Alzheimers Disease Assessment Scale Cognitive section (ADAS-Cog) will constitute the major research outcome measure used to assess response to transcranial alternating current stimulation (tACS).The ADAS-Cog scale is a scale used for clinical assessment of dementia patients with some memory efficiency tests, which can be used as an objective assessment of memory. The scale is considered a tool capable of providing a specific assessment of the severity of cognitive and non-cognitive behavioral impairments in people with Alzheimer's disease or dementia. The advantage of the ADAS-Cog compared to other scales used in the same clinical area is that its score quantifies clinical and impressionistic aspects of the patient assessed by the examiner, as well as objectively defined cognitive characteristics. The higher the ADAS-Cog score, the worse the cognitive function. The minimum value is 0 and the maximum is 86.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
Secondary outcomes (14)
electroencephalography
EEG recordings were obtained from each subject based on 64 electrode locations of the International 10-20 system (sampling frequency 1000Hz).The recorded EEG data were filtered with a second order band-pass Butterworth filter with cutoff frequencies of 0.5 and 60 Hz. For each testing condition, data with muscular, ocular and other types of artifacts were manually discarded and 60 seconds of stationary EEG signal were selected. Only these segments were accepted for further analysis.
The analysis in the frequency domain was performed using Welch's periodogram method. Recordings were segmented into tracts of 10 seconds each, windowed with a Hanning window, with 50% overlap. The relative powers of the spectral components in the typical spectral bands delta (δ: 0.5-4 Hz), theta (θ: 4-8 Hz), alpha1 (α1: 8-10.5 Hz), alpha2 (α2: 10.5-13 Hz), beta1 (β1: 13-20 Hz), beta2 (β2: 20-30 Hz) and gamma (γ: 30-60 Hz) were computed by dividing the absolute power in each band by the total power.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
Associative Memory
The associative memory test uses facial cue word recall. The subjects memorized 20 photos of faces displayed on a screen in gray scale for 4 seconds each. When each card was presented, a common word appeared alongside the face. The subjects had to remember associations between faces and words by association. After a delay of about a minute after the study ended, the subjects were shown 12 of the same faces in different random orders, instructing them to recall the words that appeared with each face during the study. Recorded the correct number of words each face recalled. The faces were taken from a database of 24 amateur models. Each test format included only male or female faces.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
MMSE(Mini Mental State Examination)
The full name of MMSE is mini-mental state examination, and the scale consists of 30 subject, include the following seven aspects: time orientation, place orientation,immediate memory,attention and calculation,delay memory,language, visual space.One point is awarded for each question correctly answered during MMSE evaluation. If subject give the wrong answer or don't know answe he/she awarded 0 score, scope of scale score of 0 to 30 points. The higher the score, the better.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
LMT (Logic Memory Test)
The changes in LMT will constitute the secondary research outcome
Measured: changes from baseline at 14 days and 12 weeks post-treatment
DST (Digital Span Test; Forward and Backward)
The changes in DST will constitute the other research outcome.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
TMT (Trail Making Test)
The Trail Making Test (TMT) is divided into two parts, part A and part B. Part A requires the subject to connect 25 Numbers on the paper in sequence, and part B requires the subject to connect 25 Numbers of different colors alternately in sequence. The time it takes for the subject to complete all the Numbers is the subject's final score.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
HAMD (Hamilton Depression Scale)
The changes in HAMD will constitute the other research outcome. The examination content consists of 17 questions (about 10 minutes), with a full score of 52. The higher the score, the more severe the depressive symptoms are.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
HAMA (Hamilton Anxiety Scale)
The changes in HAMD will constitute the other research outcome. The examination content consists of 14 questions (about 10 minutes), with a full score of 56. The higher the score, the more severe the anxiety symptoms are.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
NPI (Neuropsychiatric Inventory)
The changes in HAMD will constitute the other research outcome.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
changes in Montreal Cognitive Assessment (MoCA)
MoCA was developed by Nasreddine et al. based on clinical experience and reference to the MMSE cognitive items and scores, and the final version was finalized in November 2004. We adopted a localized version (Mandarin version,includes 2 alternative versions) in line with the Chinese cultural background.It includes 11 inspection items in 8 cognitive fields, including visual structure skills, executive function, naming, attention and calculation, language, abstract thinking, memory, and orientation. With a total score of 30 or more than 26, it is normal. Anyone who has been education for less than 12 years will need to add one point to his final score.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
GDS(Geriatric depression scale)
The Geriatric Depression Scale (GDS) was created in 1982 by Brank et al. and is dedicated to screening for depression in the elderly. The most suitable feelings for the elderly in the past week were evaluated.There are 30 items in the scale, the total score is 30 points. The higher the score, the more obvious the depressive symptoms. It is generally considered that less than 10 points is normal.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
JLOT(Judgment of line Judgment of line orientation test orientation test)
The JLOT test was determined by Benton et al. in 1994. There are two versions of H and V. The difference is that the order in which the pictures are presented is different. Each version contains 35 images, of which the official test consists of 30 images, and the other 5 images are for the participants to learn. The final score is the correct number of subjects to answer, the full score is 30 points, the higher the score, the better the space perception ability of the subject.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
HVOT(Hooper visual organization test Hooper visual organization test)
The changes in HVOT(Hooper visual organization test Hooper visual organization test) will constitute assess response to rTMS the secondary research outcome measure.HVOT is a cognitive test used to evaluate the perceived structure of the subject. It consists of 30 items,and each question is 1 point and the total score is 30 points. The final score is the correct number of subjects to answer, the full score is 30 points, the higher the score, the better the space perception ability of the subject.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
The Stroop color test
The Stroop color word test was developed by Stroop in 1935 and is used to evaluate the attention function of the subject. The subject is required to correctly read the target color on the stimulus card and record the completion time. The final completion time is the score of the participant. The shorter the time used, the better the performance of the subjects.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565143
- Sponsor's protocol ID
- AHMU-TACS-AD
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fang M, Yan Y, Song W, Geng Z, Wang L, Hu C, Li W, Song B, Chen M, Dai Y, Hu Y, Zhou S, Guo H, Ji G, Hu P, Wang K, Wu X. Effects of 40-Hz transcranial alternating current stimulation on cognition and neural markers in Alzheimer's disease: a randomized, sham-controlled trial. Alzheimers Res Ther. 2026 Apr 1;18(1):115. doi: 10.1186/s13195-026-02033-4.
PubMed 41918026
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Alternating Current Stimulation(tACS) for Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06565143
- Acronym / sponsor ID
- AHMU-TACS-AD
- Conditions
- Transcranial Alternating Current Stimulation, Electroencephalography, Early Alzheimer's Disease
- Keywords
- Transcranial Alternating Current Stimulation, Electroencephalography, Neuropsychology, Early Alzheimer's Disease, Alzheimer's Disease Assessment Scale-Cognitive Subscale, Working Memory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 21 Aug 2024 (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.
To investigate the clinical effect neural mechanism of transcranial alternating current stimulation in early Alzheimer's disease
Detailed description
Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and tACS at the First Affiliated Hospital of Anhui medical university. Patients were randomly allocated to tACS group and the sham group. There are about 20 patients in each group. For the all patients, allocation was by coin toss. Patients were studied using a double-blind design. Study participants and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only tACS administrators had access to the randomization list; they had minimal contact with the patients, and no role in cognitive and symptom assessments. Each patient would be treated for continuous 14 days by tACS.
Before the tACS treatment, a series of cognitive assessments and neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) as the primary outcome measure and various other tasks and questionnaires to measure cognition (including MoCA,MMSE, DS, Stroop test, TMT, BNT-30, VFT, CDT,JLOT. Form H,HVOT), memory (CAVLT, LMT), emotion(HAMA-17,HAMD-14,GDS-30), behavioral and psychological symptoms(NPI), and treatment tolerability. All the tests are conducted in two days. The patient received resting EEG data collection. After the last treatment, the MoCA, and associative memory were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, resting EEG. Two months after the last treatment, participants were interviewed to obtain the same assessment as before. They were instructed to focus their answers on the past months.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcranial alternating current stimulation-Real | Active comparator | Device: Transcranial alternating current stimulationParticipants will receive real tACS once daily for 14 days |
| transcranial alternating current stimulation-Sham | Sham comparator | Device: Sham transcranial alternating current stimulationParticipants will receive sham tACS once daily for 14 days |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject diagnosed with early Alzheimer's disease or related diseases according to NIA-AA criteria.
- Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia.
- CDR score ≤ 2.
- Subject under treatment by IAChE for at least 3 months.
- psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months.
Key exclusion criteria (8 listed)
- CDR > 2
- Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
- History of head injury,stroke,or other neurologic disease.
- Organic brain defects on T1 or T2 images.
- History of seizures or unexplained loss of consciousness.
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 stimulationTranscranial alternating current stimulation (tACS) is a non-invasive brain stimulation tool that alters cortical excitability and activity via application of weak alternating currents. | Device | transcranial alternating current stimulation-Real |
| Sham transcranial alternating current stimulationIn the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (30s); no current was delivered during the 30-minute intervention. | Device | transcranial alternating current stimulation-Sham |
Primary outcome
Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
The changes in Alzheimers Disease Assessment Scale Cognitive section (ADAS-Cog) will constitute the major research outcome measure used to assess response to transcranial alternating current stimulation (tACS).The ADAS-Cog scale is a scale used for clinical assessment of dementia patients with some memory efficiency tests, which can be used as an objective assessment of memory. The scale is considered a tool capable of providing a specific assessment of the severity of cognitive and non-cognitive behavioral impairments in people with Alzheimer's disease or dementia. The advantage of the ADAS-Cog compared to other scales used in the same clinical area is that its score quantifies clinical and impressionistic aspects of the patient assessed by the examiner, as well as objectively defined cognitive characteristics. The higher the ADAS-Cog score, the worse the cognitive function. The minimum value is 0 and the maximum is 86.
14 secondary outcomes
electroencephalography
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
Associative Memory
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
MMSE(Mini Mental State Examination)
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
LMT (Logic Memory Test)
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
DST (Digital Span Test; Forward and Backward)
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
TMT (Trail Making Test)
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
HAMD (Hamilton Depression Scale)
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
HAMA (Hamilton Anxiety Scale)
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
NPI (Neuropsychiatric Inventory)
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
changes in Montreal Cognitive Assessment (MoCA)
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
GDS(Geriatric depression scale)
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
JLOT(Judgment of line Judgment of line orientation test orientation test)
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
HVOT(Hooper visual organization test Hooper visual organization test)
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
The Stroop color test
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 41918026Fang M, Yan Y, Song W, Geng Z, Wang L, Hu C, Li W, Song B, Chen M, Dai Y, Hu Y, Zhou S, Guo H, Ji G, Hu P, Wang K, Wu X. Effects of 40-Hz transcranial alternating current stimulation on cognition and neural markers in Alzheimer's disease: a randomized, sham-controlled trial. Alzheimers Res Ther. 2026 Apr 1;18(1):115. doi: 10.1186/s13195-026-02033-4.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial alternating current stimulation in people with Transcranial Alternating Current Stimulation and Electroencephalography, run by Anhui Medical University at 1 site in China.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang, PhD (+86-0551-62922263 ext. +86, wangkai1964@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog) (time frame: changes from baseline at 14 days and 12 weeks post-treatment). 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 NCT06565143, 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 21 Aug 2024.