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Multisensory 40-Hz Stimulation for Alzheimer's Disease

2026년 8월 6일 업데이트: huang yue, Beijing Tiantan Hospital

A Randomized, Sham-Controlled Study of the Safety and Efficacy of Multisensory 40-Hz Stimulation in Patients With Alzheimer's Disease

This study aims to evaluate the safety and preliminary efficacy of combined auditory and visual 40-Hz stimulation in participants with biomarker-confirmed Alzheimer's disease spectrum disorders. A total of 60 participants with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia will be randomly assigned in a 1:1 ratio to receive either active multisensory 40-Hz stimulation or sham stimulation. The intervention will be administered for 60 minutes once daily for 4 consecutive weeks. Clinical assessments, electroencephalography, multimodal magnetic resonance imaging, and blood biomarkers will be evaluated before and after the intervention. Additional clinical, electroencephalographic, and blood biomarker assessments will be performed at 3 and 6 months after the intervention.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

Alzheimer's disease is associated with abnormalities in neural network activity and gamma-frequency oscillations. Preclinical studies suggest that sensory stimulation at 40 Hz may entrain gamma oscillations and influence Alzheimer's disease-related pathological and functional changes.

This single-center, prospective, randomized, sham-controlled study will investigate the safety and preliminary efficacy of combined auditory and visual 40-Hz stimulation in participants with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia. Eligible participants will have evidence of Alzheimer's disease pathology based on positron emission tomography, cerebrospinal fluid, or blood biomarkers.

Participants will be randomly assigned in a 1:1 ratio to active multisensory 40-Hz stimulation or sham stimulation. Both interventions will be administered for 60 minutes once daily for 4 weeks. Clinical assessments, electroencephalography, multimodal magnetic resonance imaging, and blood biomarkers will be obtained at baseline and after completion of the intervention. Clinical assessments, electroencephalography, and blood biomarkers will also be collected at 3 and 6 months after treatment to assess the durability of treatment effects. Safety will be evaluated through the incidence and severity of adverse events throughout the intervention and follow-up periods.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Jinhui Yin, MD
  • 전화번호: +8619801177703
  • 이메일: yjh_hw@163.com

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Provision of written informed consent by the participant or the participant's legally authorized representative.
  2. Age 45 to 75 years, inclusive.
  3. Completion of at least primary school education.
  4. Diagnosis within the Alzheimer's disease spectrum according to the National 5.Institute on Aging and Alzheimer's Association criteria.

Mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia, defined by a Montreal Cognitive Assessment score of ≤24 for participants with middle school education or above, or ≤23 for participants with primary school education, and a Clinical Dementia Rating global score of 0.5 or 1.

6.Evidence of Alzheimer's disease pathology based on a positive positron emission tomography, cerebrospinal fluid, or blood biomarker result.

7.Alzheimer's disease-related medications are expected to remain stable during the study period.

Exclusion Criteria:

  1. Current or previous history of a neurological disorder other than Alzheimer's disease that may affect cognition or study assessments, including epilepsy, stroke, multiple sclerosis, poorly controlled migraine, intracranial injury, previous neurosurgery, or head trauma with residual neurological impairment.
  2. Contraindication to magnetic resonance imaging, electroencephalography, auditory stimulation, visual stimulation, or noninvasive brain stimulation.
  3. Current major depressive disorder or another psychiatric disorder that, in the investigator's judgment, may interfere with study participation or outcome assessment.
  4. Clinically significant structural abnormalities on brain magnetic resonance imaging, including hydrocephalus, stroke, or another structural lesion that may confound study results.
  5. Severe cardiovascular or pulmonary disease.
  6. Cognitive impairment primarily attributable to another disorder, including frontotemporal dementia, dementia with Lewy bodies, Parkinson's disease dementia, or vascular dementia.
  7. Clinically significant suicide risk or a suicide attempt within the previous 12 months.
  8. Behavioral disturbance, including severe aggression, agitation, or impulsivity, that may interfere with adherence to study procedures.
  9. Current or planned treatment with an anti-amyloid monoclonal antibody during the study period.
  10. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Active Multisensory 40-Hz Stimulation
장치: Multisensory 40-Hz Stimulation Device
A device delivering synchronized auditory and visual stimulation at a frequency of 40 Hz. Each intervention session will last 60 minutes and will be administered once daily for 4 consecutive weeks.
가짜 비교기: Sham Multisensory Stimulation
장치: Sham Multisensory Stimulation
The sham device will reproduce the appearance, setup, and duration of the active intervention but will not deliver synchronized 40-Hz auditory and visual stimulation.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale Score
기간: Baseline to 1 week after completion of the 4-week intervention
The Alzheimer's Disease Assessment Scale-Cognitive Subscale 11-item version assesses cognitive performance in domains including memory, language, and praxis. Total scores range from 0 to 70, with higher scores indicating greater cognitive impairment. Change from baseline will be calculated as the post-intervention score minus the baseline score.
Baseline to 1 week after completion of the 4-week intervention
Incidence of Treatment-Emergent Adverse Events
기간: From the first intervention session through 6 months after completion of the intervention
Number and proportion of participants experiencing one or more treatment-emergent adverse events from the first intervention session through completion of follow-up. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events, version 5.0.
From the first intervention session through 6 months after completion of the intervention

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Resting-State Electroencephalographic Gamma-Band Power
기간: Baseline to 1 week after completion of the 4-week intervention
Change in resting-state electroencephalographic power within the predefined gamma-frequency band following the intervention. Gamma-band power will be calculated using a prespecified electroencephalographic preprocessing and spectral analysis pipeline.
Baseline to 1 week after completion of the 4-week intervention
Change From Baseline in Montreal Cognitive Assessment Score
기간: Baseline to 1 week after completion of the 4-week intervention
The Montreal Cognitive Assessment evaluates global cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
Baseline to 1 week after completion of the 4-week intervention
Change From Baseline in Plasma Phosphorylated Tau 217 Concentration
기간: Baseline to 1 week after completion of the 4-week intervention
Plasma phosphorylated tau 217 concentration will be measured in fasting blood samples using a prespecified validated assay.
Baseline to 1 week after completion of the 4-week intervention
Glymphatic MRI marker
기간: Baseline to 1 week after completion of the 4-week intervention
The DTI-ALPS index will be calculated from diffusion magnetic resonance imaging as a noninvasive imaging marker related to water diffusivity along perivascular spaces.
Baseline to 1 week after completion of the 4-week intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Beijing Tiantan Hospital

수사관

  • 수석 연구원: Yue Huang, Beijing Tiantan Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 10월 30일

연구 완료 (추정된)

2027년 10월 30일

연구 등록 날짜

최초 제출

2026년 8월 6일

QC 기준을 충족하는 최초 제출

2026년 8월 6일

처음 게시됨 (실제)

2026년 8월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 6일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • HX-A-2025116

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Deidentified individual participant data underlying the results reported in the primary publication may be shared with qualified researchers upon reasonable request, following approval by the principal investigator and the institutional ethics committee.

IPD 공유 기간

Beginning 12 months after publication of the primary study results and available for 3 years.

IPD 공유 액세스 기준

Requests must include a scientifically sound research proposal and a statistical analysis plan. Data access will require institutional approval and execution of a data use agreement.

IPD 공유 지원 정보 유형

  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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