Alzheimer DiseaseNCT04088643
4Hz Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease
A study testing transcranial alternating current stimulation in people with Alzheimer Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The goal of this study is to explore the efficacy and safety of 4Hz transcranial alternating current stimulation (tACS) in patients with mild Alzheimer's disease (AD). The study will recruit 40 individuals with mild AD, and the participants will be randomized to either a 4 Hz tACS group or a sham stimulation group. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Alzheimer 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
- 14 Oct 2019to Dec 2023
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with informed consent;
- 45-75 years of age;
- At least 6 years of education;
- AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines;
- Clinical Dementia Rating Scale (CDR)=1.0;
- Positive findings in amyloid PET imaging or amyloid protein levels in CSF;
- On a stable dose of cholinesterase inhibitors (e.g. donepezil or rivastigmine) as defined as 6 consecutive weeks of treatment at an unchanging dose, and without any intentions to modify the dosage during the observation period.
Who cannot join
- Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke, progressive neurologic disease (e.g. multiple sclerosis), poorly controlled migraines or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment;
- Contraindication for undergoing MRI or receiving tACS;
- Eczema or sensitive skin;
- Familial AD;
- Depression or other psychiatric disorders;
- Abnormal brain structural magnetic resonance imaging (MRI) scan, including hydrocephalus, stroke, structural lesions, etc. that would potentially confound the outcome;
- Severe cardiovascular/pulmonary disorders;
- Other conditions, in the investigator's opinion, might not be suitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of 4Hz Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease: A Randomized Controlled Clinical Trial
The goal of this study is to explore the efficacy and safety of 4Hz transcranial alternating current stimulation (tACS) in patients with mild Alzheimer's disease (AD). The study will recruit 40 individuals with mild AD, and the participants will be randomized to either a 4 Hz tACS group or a sham stimulation group. Both groups will undergo 30 one-hour sessions across 3 weeks (21 days). At the end of the intervention and 3-month follow-up, all subjects will repeat the baseline assessments.
Read the detailed description
Background: Recently, transcranial alternating current stimulation (tACS), which could interact with ongoing neuronal activity, has emerged as a potentially effective and promising treatment for Alzheimer's disease (AD), and the 4Hz frequency was suggested to improve working memory Methods: The proposed study is a double-blinded, randomized controlled trial that will include 40 individuals with mild AD, and the participants will be randomized to either a 4Hz tACS group or a sham stimulation group. Both groups will undergo 30 one-hour sessions in 3 weeks (21 days). The outcome measures will be assessed at baseline, end of intervention and 3 months after the first session. Primary outcome is global cognitive function, assessed by the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog), and the second outcomes include changes in other neuropsychological assessments, structural MRI, resting electroencephalogram (EEG) and simultaneous EEG-functional MRI (fMRI).
- Conditions
- Alzheimer Disease
- Being tested
- transcranial alternating current stimulation, sham stimulation
- 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
The alternating current is administered through medical grade conductive pads that are produced specifically for the Nexalin technology. The pads are places on the forehead and behind each ear, and are connected to the Nexalin device with thin cables. Intervention will be implemented with a tACS device with 4Hz frequency and a peak-to-peak amplitude of 15mA, 30 one-hour sessions in 3 weeks (21 days).
sham stimulationDevice
Electrodes will also be put on patient's forehead and behind each ear. The sham stimulator has the exactly same appearance with the true stimulator. Participants and operators cannot determine whether the stimulator is true based on its appearance or patients' feelings. However, when the device is started, no current flows through the electrodes. Participants in this controlled group will also receive sham stimulations with 30 one-hour sessions in 21 days.
| Study group | Role | What they receive |
|---|---|---|
| tACS group | Experimental | NEXALIN ADI transcranial alternating current stimulator Receives: Device: transcranial alternating current stimulation |
| sham stimulation group | Sham comparator | Sham stimulator provided by NEXALIN company Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version)
ADAS-cog 11 scale ranges from 0 to 70, and higher value represents a worse outcome. This study will use ADAS-cog to assess changes in the global cognitive function after intervention.
Measured: up to 21 days (end of intervention)
Secondary outcomes (15)
Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version).
ADAS-cog 11 scale ranges from 0 to 70, and higher value represents a worse outcome. This study will use ADAS-cog to assess changes in the global cognitive function after intervention.
Measured: 3 months
Change in brain volume and white matter integrity
Structural MRI will be used to measure brain volume and white matter integrity.
Measured: up to 21 days (end of intervention), 3 months
Change in brain connectivity
Functional MRI and resting-state EEG will be used to measure brain connectivity.
Measured: up to 21 days (end of intervention), 3 months
Change in Mini-mental State Examination
Mini-mental State Examination (MMSE) will be used to evaluate the general cognitive function. MMSE ranges from 0 to 30, and higher value represents a better outcome.
Measured: up to 21 days (end of intervention), 3 months
Change in Montreal Cognitive Assessment
Montreal Cognitive Assessment (MoCA) will be used to evaluate the general cognitive function. MoCA ranges from 0 to 30, and higher value represents a better outcome.
Measured: up to 21 days (end of intervention), 3 months
Change in Clinical Dementia Rating Scale sum of the boxes
Clinical Dementia Rating Scale sum of the boxes (CDR-SB) will be used to evaluate the general cognitive function. CDR-SB ranges from 0 to 18, and higher value represents a worse outcome.
Measured: up to 21 days (end of intervention), 3 months
Change in memory function
WHO-UCLA Auditory Verbal Learning Test will be used to assess memory function. It ranges from 0 to 45, and higher value represents a better outcome.
Measured: up to 21 days (end of intervention), 3 months
Change in Digit span forward
Digit span will be used to assess attention. It ranges from 3 to 10, and higher value represents a better outcome.
Measured: up to 21 days (end of intervention), 3 months
Change in Digit span backward
Digit span backward will be used to assess executive function. It ranges from 2 to 8, and higher value represents a better outcome.
Measured: up to 21 days (end of intervention), 3 months
Change in Trail Making Test
Trail-Making Test B minus A score will be used to assess executive function. Trail-Making Test B minus A ranges from -150 to 300, higher value represents a worse outcome.
Measured: up to 21 days (end of intervention), 3 months
Change in Boston Naming Test
Boston Naming Test will be used to assess language function. It ranges from 0 to 30, and higher value represents a better outcome.
Measured: up to 21 days (end of intervention), 3 months
Change in Neuropsychiatric Inventory (NPI)
The Neuropsychiatric Inventory will be used to measure neuropsychiatric symptoms. It ranges from 0 to 144, and higher value represents a worse outcome.
Measured: up to 21 days (end of intervention), 3 months
Change in Geriatric Depression Scale (GDS)
The Geriatric Depression Scale will be used to measure neuropsychiatric symptoms. It ranges from 0 to 30, and higher value represents a worse outcome.
Measured: up to 21 days (end of intervention), 3 months
Change in Activities of Daily Living
Activities of Daily Living (ADL) scale will be used to assess the change of life quality. It ranges from 20 to 80. The "20" represents normal life ability and the higher score presents the worse life ability.
Measured: up to 21 days (end of intervention), 3 months
Side-effects of tACS
Adverse Events as a result of tACS stimulation will be reported.
Measured: up to 21 days (end of intervention), 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start14 Oct 2019
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Tang, M.D., Ph.D., Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088643
- Sponsor's protocol ID
- 2018077
- Status last verified
- Jul 2022
- First submitted
- 11 Sep 2019
- Last updated
- 13 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of 4Hz Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04088643
- Acronym / sponsor ID
- 2018077
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Sep 2019 (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 goal of this study is to explore the efficacy and safety of 4Hz transcranial alternating current stimulation (tACS) in patients with mild Alzheimer's disease (AD). The study will recruit 40 individuals with mild AD, and the participants will be randomized to either a 4 Hz tACS group or a sham stimulation group. Both groups will undergo 30 one-hour sessions across 3 weeks (21 days). At the end of the intervention and 3-month follow-up, all subjects will repeat the baseline assessments.
Detailed description
Background: Recently, transcranial alternating current stimulation (tACS), which could interact with ongoing neuronal activity, has emerged as a potentially effective and promising treatment for Alzheimer's disease (AD), and the 4Hz frequency was suggested to improve working memory Methods: The proposed study is a double-blinded, randomized controlled trial that will include 40 individuals with mild AD, and the participants will be randomized to either a 4Hz tACS group or a sham stimulation group. Both groups will undergo 30 one-hour sessions in 3 weeks (21 days). The outcome measures will be assessed at baseline, end of intervention and 3 months after the first session. Primary outcome is global cognitive function, assessed by the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog), and the second outcomes include changes in other neuropsychological assessments, structural MRI, resting electroencephalogram (EEG) and simultaneous EEG-functional MRI (fMRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tACS group | Experimental | Device: transcranial alternating current stimulationNEXALIN ADI transcranial alternating current stimulator |
| sham stimulation group | Sham comparator | Device: sham stimulationSham stimulator provided by NEXALIN company |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with informed consent;
- 45-75 years of age;
- At least 6 years of education;
- AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines;
- Clinical Dementia Rating Scale (CDR)=1.0;
Key exclusion criteria (8 listed)
- Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke, progressive neurologic disease (e.g. multiple sclerosis), poorly controlled migraines or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment;
- Contraindication for undergoing MRI or receiving tACS;
- Eczema or sensitive skin;
- Familial AD;
- Depression or other psychiatric disorders;
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 stimulationThe alternating current is administered through medical grade conductive pads that are produced specifically for the Nexalin technology. The pads are places on the forehead and behind each ear, and are connected to the Nexalin device with thin cables. Intervention will be implemented with a tACS device with 4Hz frequency and a peak-to-peak amplitude of 15mA, 30 one-hour sessions in 3 weeks (21 days). | Device | tACS group |
| sham stimulationElectrodes will also be put on patient's forehead and behind each ear. The sham stimulator has the exactly same appearance with the true stimulator. Participants and operators cannot determine whether the stimulator is true based on its appearance or patients' feelings. However, when the device is started, no current flows through the electrodes. Participants in this controlled group will also receive sham stimulations with 30 one-hour sessions in 21 days. | Device | sham stimulation group |
Primary outcome
Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version)
Time frame: up to 21 days (end of intervention)
ADAS-cog 11 scale ranges from 0 to 70, and higher value represents a worse outcome. This study will use ADAS-cog to assess changes in the global cognitive function after intervention.
15 secondary outcomes
Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version).
Time frame: 3 months
Change in brain volume and white matter integrity
Time frame: up to 21 days (end of intervention), 3 months
Change in brain connectivity
Time frame: up to 21 days (end of intervention), 3 months
Change in Mini-mental State Examination
Time frame: up to 21 days (end of intervention), 3 months
Change in Montreal Cognitive Assessment
Time frame: up to 21 days (end of intervention), 3 months
Change in Clinical Dementia Rating Scale sum of the boxes
Time frame: up to 21 days (end of intervention), 3 months
Change in memory function
Time frame: up to 21 days (end of intervention), 3 months
Change in Digit span forward
Time frame: up to 21 days (end of intervention), 3 months
Change in Digit span backward
Time frame: up to 21 days (end of intervention), 3 months
Change in Trail Making Test
Time frame: up to 21 days (end of intervention), 3 months
Change in Boston Naming Test
Time frame: up to 21 days (end of intervention), 3 months
Change in Neuropsychiatric Inventory (NPI)
Time frame: up to 21 days (end of intervention), 3 months
Change in Geriatric Depression Scale (GDS)
Time frame: up to 21 days (end of intervention), 3 months
Change in Activities of Daily Living
Time frame: up to 21 days (end of intervention), 3 months
Side-effects of tACS
Time frame: up to 21 days (end of intervention), 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
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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.
Yi Tang, M.D., Ph.D. principal investigator
Xuanwu Hospital, Beijing
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 Alzheimer Disease, run by Xuanwu Hospital, Beijing 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 7 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 13 Jul 2022. 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?
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?
Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version) (time frame: up to 21 days (end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2022.