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Recruiting NCT06565143

Effect of Transcranial Alternating Current Stimulation(tACS) for Early Alzheimer's Disease

No phase Interventional Transcranial Alternating Current Stimulation Electroencephalography Early Alzheimer's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial alternating current stimulation, Sham transcranial alternating current stimulation.
Who it may be relevant to
Registry conditions: Transcranial Alternating Current Stimulation, Electroencephalography, Early Alzheimer's Disease. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device Transcranial alternating current stimulation
    Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation tool that alters cortical excitability and activity via application of weak alternating currents.
  • Device Sham transcranial alternating current stimulation
    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.

Primary outcome measures

  • Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog) [Time frame: changes from baseline at 14 days and 12 weeks post-treatment]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

China · 1 center
  • Anhui Medical University — Hefei

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. PMID 41918026

Identifiers

NCT: NCT06565143 · AHMU-TACS-AD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗