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NOT YET RECRUITING
NCT07230158
NA

Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease II (TRANSFORM-AD II)

Sponsor: Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

Summary

The goal of this study is to explore the efficacy and safety of transcranial alternating current stimulation (tACS) in patients with amnestic mild cognitive impairment due to Alzheimer's disease (AD-aMCI) and patients with mild Alzheimer's disease dementia (AD-MD). The study will recruit 160 individuals with mild cognitive impairment with evidence of amyloid plaques in the brain through Positron Emission Tomography (PET) imaging. Participants will undergo baseline cognitive assessment, structural and functional MRI characterization, PiB-PET, and EEG measurement. The participants will be randomized to either a tACS group or a sham stimulation group. At the end of the intervention, all subjects will repeat the baseline assessments.

Official title: The Effects of TRanscranial AlterNating Current Stimulation FOR Patients With Mild Alzheimer's Disease II (TRANSFORM-AD II Study): A Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

50 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2025-11-30

Completion Date

2027-12-01

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

DEVICE

sham stimulation

Electrodes will also be placed on the patient's forehead and behind both ears. The sham stimulator is identical in appearance to the true stimulator. Neither participants nor operators can distinguish whether the stimulator is real based on its appearance or the patient's sensations. However, when the device is activated, no current flows through the electrodes. Participants in this group will receive sham stimulation with 60 one-hour sessions within 8 weeks.

DEVICE

transcranial alternating current stimulation

The alternating current is delivered through medical-grade conductive electrode pads manufactured specifically for Nexalin technology. The electrode pads are placed on the forehead and behind both ears, and are connected to the Nexalin device with thin cables. The intervention will be conducted with a tACS device: 50 minutes of high-gamma frequency (77.5 Hz) combined with 10 minutes of low-gamma frequency (40 Hz), with a peak-to-peak amplitude of 15 mA. A total of 60 one-hour sessions will be completed within 8 weeks.

Locations (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China