- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07608640
Management of Age-Related Auditory Decline and Early Warning of Its Co-occurring Dementia (AHEAD)
Against the backdrop of global population aging, age-related hearing loss (ARHL) has reached epidemic proportions and is increasingly recognized as an independent risk factor for cognitive decline and other major neurodegenerative diseases. This study aims to systematically develop an integrated framework for the early warning, precise assessment, and intervention management of ARHL.
Using a national multicenter design, the project will establish a prospective cohort of more than 3,000 older adults. We will integrate multimodal data including audiological tests, cognitive function assessments, and blood biomarkers, and employ artificial intelligence and unsupervised machine learning methods to address critical bottlenecks in the field: the unclear mechanistic link between ARHL and cognitive decline, and the lack of validated predictive tools.
Specifically, this study will: (1) develop data-driven clinical classification criteria for ARHL; (2) create a personalized "Hearing Health Clock" predictive model; (3) identify minimally invasive blood biomarkers for early detection of cognitive impairment; and (4) formulate a multidimensional early dementia screening program suitable for community-wide implementation. The findings will provide scientific evidence and practical tools for the prevention and control of hearing and cognitive health risks in older adults in China.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Lumeng Han
- 전화번호: +8666876060
- 이메일: 1345140372@qq.com
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100048
- The 6th Medical Center of Chinese PLA General Hospital
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연락하다:
- Lumeng Han
- 전화번호: +8666876060
- 이메일: 1345140372@qq.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
This study enrolls community-dwelling adults aged 60 years and older from multiple medical centers in China. All participants are permanent local residents with annual residence of no less than 9 months, clear consciousness, and able to cooperate with standardized audiological examinations, cognitive function assessments, questionnaire surveys and blood sample collection.
A total of more than 3,000 older adults will be recruited for the cross-sectional baseline survey. Among them, a sub-cohort of no fewer than 150 older adults with sensorineural hearing loss, bilaterally symmetric auditory thresholds without middle ear disorders, and no non-age-related causes of hearing impairment will be included for 3-year annual longitudinal follow-up.
Individuals with inability to complete pure-tone audiometry, established neurological diseases, severe organ dysfunction, advanced malignant tumor with short life expectancy, or any other inappropriate conditions assessed by investigators are exclud
설명
Inclusion Criteria:
- Aged 60 years or older.
- Clear consciousness and able to cooperate with all study assessments and examinations.
- Permanent local residents who have lived in the area for at least 9 months per year and are willing to complete long-term follow-up.
long-term follow-up:
- Diagnosis of sensorineural hearing loss.
- Bilaterally symmetric hearing with air conduction threshold difference ≤15 dB at 0.5 kHz, 1 kHz, 2 kHz and 4 kHz between two ears.
- Hearing loss not caused by non-age-related factors.
Exclusion Criteria:
- Unable to complete pure-tone audiometry and other auditory examinations. History of central nervous system diseases, including Parkinson's disease, stroke, intracranial tumor or brain trauma.
- Severe uncontrolled systemic diseases (cardiac, pulmonary, hepatic, renal insufficiency) or advanced malignant tumor with expected survival less than 3 years.
- Any other condition judged by the investigator inappropriate for study enrollment.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Community-Dwelling Older Adults Group
Older adults with bilaterally symmetric hearing and no middle ear abnormalities
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Not applicable-observational study
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of dementia and cognitive decline, and progression of age-related auditory decline in community-dwelling older adults
기간: 3 years from baseline enrollment
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To determine the 3-year cumulative incidence of all-cause dementia and cognitive decline, and to assess the progression rate of age-related auditory decline among community-dwelling older adults aged 60 years and above.
Based on a multicenter prospective cohort of more than 3000 participants, this primary outcome will clarify the longitudinal association between the deterioration of auditory function and subsequent cognitive impairment and dementia risk, through standardized audiological testing and repeated cognitive function assessment at regular follow-up visits.
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3 years from baseline enrollment
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공동 작업자 및 조사자
수사관
- 연구 의자: Shiming Yang, The Medical Ethics Committee of the 6th Medical Center of Chinese PLA General Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CFH 2026-1-5071 (기타 보조금/기금 번호: Capital's Funds for Health Improvement and Research)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
백치에 대한 임상 시험
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ACADIA Pharmaceuticals Inc.모병Lewy Body Dementia Psychosis미국, 체코, 세르비아, 프랑스, 불가리아, 이탈리아
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ACADIA Pharmaceuticals Inc.초대로 등록