Effect of Transcranial Alternating Current Stimulation(tACS) for Early Alzheimer's Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Transcranial alternating current stimulation, Sham transcranial alternating current stimulation.
- Кому может быть актуально
- Состояния в реестре: Transcranial Alternating Current Stimulation, Electroencephalography, Early Alzheimer's Disease. Базовые параметры: 50 лет — 85 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
To investigate the clinical effect neural mechanism of transcranial alternating current stimulation in early Alzheimer's disease
Подробное описание
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.
Вмешательства
- Устройство 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. - Устройство 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.
Первичные конечные точки
- Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog) [Срок оценки: changes from baseline at 14 days and 12 weeks post-treatment]
Вторичные конечные точки (12)
- electroencephalography [Срок оценки: changes from baseline at 14 days and 12 weeks post-treatment]
- Associative Memory [Срок оценки: changes from baseline at 14 days and 12 weeks post-treatment]
- MMSE(Mini Mental State Examination) [Срок оценки: changes from baseline at 14 days and 12 weeks post-treatment]
- LMT (Logic Memory Test) [Срок оценки: changes from baseline at 14 days and 12 weeks post-treatment]
- DST (Digital Span Test; Forward and Backward) [Срок оценки: changes from baseline at 14 days and 12 weeks post-treatment]
- TMT (Trail Making Test) [Срок оценки: changes from baseline at 14 days and 12 weeks post-treatment]
- HAMD (Hamilton Depression Scale) [Срок оценки: changes from baseline at 14 days and 12 weeks post-treatment]
- HAMA (Hamilton Anxiety Scale) [Срок оценки: changes from baseline at 14 days and 12 weeks post-treatment]
- NPI (Neuropsychiatric Inventory) [Срок оценки: changes from baseline at 14 days and 12 weeks post-treatment]
- changes in Montreal Cognitive Assessment (MoCA) [Срок оценки: changes from baseline at 14 days and 12 weeks post-treatment]
- GDS(Geriatric depression scale) [Срок оценки: changes from baseline at 14 days and 12 weeks post-treatment]
- JLOT(Judgment of line Judgment of line orientation test orientation test) [Срок оценки: changes from baseline at 14 days and 12 weeks post-treatment]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Фундаментальное исследование
Центры проведения
Китай · 1 центр
- Anhui Medical University — Хэфэй
Публикации
- 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
Идентификаторы
NCT: NCT06565143 · AHMU-TACS-AD