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

Anhui Medical University

Status: Enrolling

Conditions: Electroencephalography; Transcranial Alternating Current Stimulation; Early Alzheimer's Disease

Treatments: Device: Transcranial alternating current stimulation; Device: Sham transcranial alternating current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06565143

AHMU-TACS-AD

Details and patient eligibility

About

To investigate the clinical effect neural mechanism of transcranial alternating current stimulation in early Alzheimer's disease

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject diagnosed with early Alzheimer's disease or related diseases according to NIA-AA criteria.
2. Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia.
3. CDR score ≤ 2.
4. Subject under treatment by IAChE for at least 3 months.
5. psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months.

Exclusion criteria

1. CDR > 2
2. Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
3. History of head injury,stroke,or other neurologic disease.
4. Organic brain defects on T1 or T2 images.
5. History of seizures or unexplained loss of consciousness.
6. Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.
7. Family history of medication refractory epilepsy.
8. History of substance abuse within the last 6 months.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

transcranial alternating current stimulation-Real

Active Comparator group

Description:

Participants will receive real tACS once daily for 14 days

Treatment:

Device: Transcranial alternating current stimulation

transcranial alternating current stimulation-Sham

Sham Comparator group

Description:

Participants will receive sham tACS once daily for 14 days

Treatment:

Device: Sham transcranial alternating current stimulation