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High-Altitude Neurodegeneration Cohort (HANC) Phase II Study (HANC Phase II)

13. Juni 2026 aktualisiert von: Zhigang Lan, West China Hospital

High-Altitude Neurodegeneration Cohort (HANC) Phase II: A Prospective Multicenter Validation Study on the Association Between Chronic Physiological Hypoxia and Multiple System Atrophy

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).

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Background: Multiple system atrophy (MSA) is a rapidly progressive synucleinopathy characterized by glial cytoplasmic inclusions in oligodendrocytes. Although most cases are considered sporadic, an environmental trigger has not been established. Epidemiological observations have reported disproportionately high MSA prevalence at high altitudes, but these have been dismissed as ascertainment bias. Chronic hypoxia stabilizes hypoxia-inducible factors (HIFs), which regulate mitochondrial gene expression and oxidative stress pathways.

Hypothesis: Chronic physiological hypoxia is an independent causal risk factor for MSA, operating through a HIF-1α-dependent mitochondrial lipid peroxidation cascade.

Study Design: Phase II is a prospective validation cohort designed to replicate findings from the retrospective Phase I (N=284,756). Unlike the retrospective Phase I which relied on healthcare claims data, Phase II collects primary data prospectively using standardized protocols.

Altitude Strata: Participants were enrolled from four altitude categories: (1) Lowland: <500 m (8 sites); (2) Intermediate: 500-2,000 m (7 sites); (3) Highland: 2,000-3,500 m (5 sites); (4) Extreme altitude: >3,500 m (3 sites).

Exposure Assessment: Residential altitude was verified through national identity registry cross-linkage. Nocturnal peripheral oxygen saturation (SpO₂) was measured using Nonin WristOx2 devices sampled at 1 Hz for three consecutive nights.

Outcome Adjudication: All potential MSA cases identified during follow-up will be adjudicated by a panel of five board-certified movement disorders specialists using the Gilman second consensus criteria. Adjudication will be supplemented by brain MRI review and video examination where available. Only probable and definite MSA cases are included in primary analyses.

Statistical Analysis: Cox proportional hazards models will be used to estimate hazard ratios for MSA incidence by altitude category and SpO₂ quartiles, adjusting for age, sex, smoking, pesticide exposure, family history, SNCA genotype, BMI, and occupational solvent exposure. Kaplan-Meier survival curves will compare MSA-free survival across altitude strata.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

20000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital of Sichuan University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

Inclusion Criteria:

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

Exclusion Criteria:

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: No Intervention: Observational Cohort
No intervention; observation of altitude exposure and SpO₂ levels
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).
Sonstiges: No Intervention: Observational Cohort
No intervention; observation of altitude exposure and SpO₂ levels
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).
Sonstiges: No Intervention: Observational Cohort
No intervention; observation of altitude exposure and SpO₂ levels
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).
Sonstiges: No Intervention: Observational Cohort
No intervention; observation of altitude exposure and SpO₂ levels

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Multiple System Atrophy (MSA) at 12 Months
Zeitfenster: Baseline to Month 12
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Altitude-MSA Association: Hazard Ratio by Altitude Category
Zeitfenster: Baseline to Month 12
Association between residential altitude category (4 strata: <500 m, 500-2,000 m, 2,000-3,500 m, >3,500 m) and MSA incidence, estimated using multivariable Cox proportional hazards models adjusted for age, sex, smoking, pesticide exposure, family history, SNCA genotype, BMI, and occupational solvent exposure.
Baseline to Month 12
SpO₂-MSA Association: Hazard Ratio by Nocturnal SpO₂
Zeitfenster: Baseline to Month 12
Association between mean nocturnal peripheral oxygen saturation (SpO₂) quartiles (<88%, 88-91%, 92-94%, >94%) and MSA incidence, estimated using multivariable Cox proportional hazards models with the same covariate adjustment set as the primary analysis.
Baseline to Month 12
MSA Subtype-Specific Incidence Rates
Zeitfenster: Baseline to Month 12
Incidence rates of MSA-P (parkinsonian subtype) and MSA-C (cerebellar subtype) separately, estimated by clinical phenotype at diagnosis.
Baseline to Month 12

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

West China Hospital

Mitarbeiter

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

13. Juni 2026

Primärer Abschluss (Geschätzt)

30. Juli 2027

Studienabschluss (Geschätzt)

30. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

13. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Juni 2026

Zuerst gepostet (Tatsächlich)

18. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • WestChinaH-HX-2026-001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

IPD-Sharing-Zeitrahmen

Data will be available beginning 12 months after study completion.

IPD-Sharing-Zugriffskriterien

Requests should be directed to the corresponding author; a signed data access agreement will be required.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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