High-Altitude Neurodegeneration Cohort (HANC) Study

NCT07657520 | Recruiting DMC

• 1 other identifier: WestChinaH-HX-2026-001
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic physiological hypoxia has been implicated in the pathogenesis of multiple system atrophy (MSA), a fatal neurodegenerative disorder of unknown etiology. This prospective, multicenter, observational cohort study (Phase II of the High-Altitude Neurodegeneration Cohort \[HANC\] study) aims to validate the association between chronic hypoxia exposure and incident MSA risk. A total of 20,000 Han Chinese participants aged 40-75 years will be enrolled from 23 sites across China spanning an altitude gradient from 4 m to 4,500 m. All participants will undergo standardized in-person assessment including questionnaires, physical examination, blood collection, and 3-night consecutive nocturnal pulse oximetry monitoring. Participants are to be followed for incident MSA over 12 months. The primary outcome is newly diagnosed MSA (probable or definite per Gilman consensus criteria), adjudicated by an independent panel of movement disorders specialists. Secondary outcomes include the association between altitude strata and MSA incidence, the association between mean nocturnal SpO₂ and MSA incidence, and incidence rates across MSA subtypes (MSA-P and MSA-C).

Conditions

Multiple System Atrophy

Keywords

Chronic Hypoxia; Altitude Sickness

Outcome Measures

Primary Outcomes (1)

• Incidence of Multiple System Atrophy (MSA) at 12 Months

  Number of participants with newly diagnosed probable or definite MSA during the 12-month follow-up period. Diagnosis is based on Gilman second consensus criteria and adjudicated by an independent panel of five movement disorders specialists. Adjudication includes brain MRI review and video examination where available.

  Baseline to Month 12

Secondary Outcomes (3)

• Altitude-MSA Association: Hazard Ratio by Altitude Category

  Baseline to Month 12

• SpO₂-MSA Association: Hazard Ratio by Nocturnal SpO₂

  Baseline to Month 12

• MSA Subtype-Specific Incidence Rates

  Baseline to Month 12

Study Arms (4)

GROUP_1_Lowland (<500 m)

Participants residing at altitudes below 500 meters. Enrollment sites include Shanghai (4 m), Guangzhou, Suzhou, Hangzhou, Wuhan, Changsha, Nanjing, and Zhengzhou.

Other: No Intervention: Observational Cohort

GROUP_2_Intermediate (500-2,000 m)

Participants residing at altitudes between 500 and 2,000 meters. Enrollment sites include Kunming (1,890 m), Guiyang (1,100 m), Lanzhou (1,520 m), Yinchuan (1,100 m), Xi'an (400 m - borderline, verify), Chengdu (500 m), and Chongqing (240 m).

Other: No Intervention: Observational Cohort

GROUP_3_Highland (2,000-3,500 m)

Participants residing at altitudes between 2,000 and 3,500 meters. Enrollment sites include Xining (2,295 m), Golog (3,700 m - verify), Haixi (2,980 m), Yushu (3,700 m), and Ganzi (3,400 m).

Other: No Intervention: Observational Cohort

GROUP_4_Extreme Altitude (>3,500 m)

Participants residing at altitudes above 3,500 meters. Enrollment sites include Lhasa (3,656 m), Nagqu (4,500 m), and Ali (4,500 m).

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No intervention; observation of altitude exposure and SpO₂ levels

GROUP_1_Lowland (<500 m); GROUP_2_Intermediate (500-2,000 m); GROUP_3_Highland (2,000-3,500 m); GROUP_4_Extreme Altitude (>3,500 m)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Han Chinese adults aged 40-75 years residing at altitudes ranging from 4 m to 4,500 m across 23 sites in China, with no prior diagnosis of parkinsonism at baseline.

You may qualify if:

• Self-identified Han Chinese ethnicity
• Age between 40 and 75 years (inclusive)
• No prior diagnosis of parkinsonism at baseline
• Permanent residence at study site location for ≥1 year prior to enrollment
• Ability to provide written informed consent

You may not qualify if:

• Pre-existing diagnosis of Parkinson's disease, multiple system atrophy, progressive supranuclear palsy, or any other parkinsonian disorder at baseline
• Severe chronic pulmonary disease (e.g., COPD GOLD stage ≥3) affecting baseline SpO₂ measurement
• Severe cardiovascular disease (e.g., New York Heart Association Class III or IV heart failure)
• Cognitive impairment precluding completion of study procedures
• Current enrollment in any interventional clinical trial
• Life expectancy \<12 months due to any medical condition

Sponsors & Collaborators

• West China Hospital: lead
• Affiliated Hospital of Qinghai University: collaborator
• Tibet Autonomous Region People's Hospital: collaborator
• Kunming Medical University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• First Affiliated Hospital of Suzhou Medical College: collaborator
• First People's Hospital of Hangzhou: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Guiyang No.1 People's Hospital: collaborator
• Lanzhou University Second Hospital: collaborator
• The First People's Hospital of Yinchuan: collaborator
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• The First People's Hospital of Xining City: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Multiple System Atrophy; Altitude Sickness

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Zhigang Lan, M.D. PhD.

CONTACT

18980606446; 158075478@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 18, 2026
• Study Start: June 13, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 12 months after study completion.
• Access Criteria: Requests should be directed to the corresponding author; a signed data access agreement will be required.

Locations

CN (1)