Clinical trial NCT06565143: Effect of Transcranial Alternating Current Stimulation(tACS) for Early Alzheimer's Disease
Official title: Effect of Transcranial Alternating Current Stimulation(tACS) for Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
Secondary outcomes:
measure: electroencephalography
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
measure: Associative Memory
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
measure: MMSE(Mini Mental State Examination)
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
measure: LMT (Logic Memory Test)
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
measure: DST (Digital Span Test; Forward and Backward)
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
measure: TMT (Trail Making Test)
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
measure: HAMD (Hamilton Depression Scale)
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
measure: HAMA (Hamilton Anxiety Scale)
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
measure: NPI (Neuropsychiatric Inventory)
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
measure: changes in Montreal Cognitive Assessment (MoCA)
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
measure: GDS(Geriatric depression scale)
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
measure: JLOT(Judgment of line Judgment of line orientation test orientation test)
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
measure: HVOT(Hooper visual organization test Hooper visual organization test)
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
measure: The Stroop color test
timeFrame: changes from baseline at 14 days and 12 weeks post-treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
References: