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Efficacy of Hyperbaric Oxygen Therapy in Alzheimer’s Disease: A Prospective Cohort Study

Efficacy of Hyperbaric Oxygen Therapy in Alzheimer’s Disease–Related Mild Cognitive Impairment: A Prospective Cohort Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125192
Enrollment
Unknown
Registered
2026-05-22
Start date
2026-05-25
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer’s disease (AD)

Interventions

Experimental group: patients with chronic hypoxia:Hyperbaric oxygen
Experimental group: patients without chronic hypoxia:Hyperbaric oxygen
control group:Without hyperbaric oxygen

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age 50–85 years; gender not restricted; 2. Diagnosis of MCI-AD: Based on the NIA–AA criteria 6: subjective cognitive decline (reported by the patient, a caregiver, or a clinician); objective evidence in one or more cognitive domains; preserved functional independence (no or minimal impairment in activities of daily living); not yet meeting diagnostic criteria for dementia; Aß PET showing abnormal amyloid deposition; tau PET showing abnormal tau protein deposition. 3. MMSE scores by educational level: illiterate >= 17 points, elementary school >= 20 points, middle school or higher >= 24 points; MoCA score < 26 (excluding 26); for those with less than 12 years of education, MoCA score < 25 (excluding 25); CDR = 0.5. 4. Patients in the trial cohort with chronic hypoxia include those with high-altitude hypoxia and obstructive sleep apnea syndrome. Patients must have a history of clear evidence or meet the diagnostic criteria for the relevant condition as determined by screening, and must continue their previous standard medication regimen throughout the treatment period. Patients in the control group should continue their previous "standard, stable treatment," but must not add or adjust any medications intended to improve cognitive function. 5. Patients must voluntarily sign an informed consent form, understand and accept the duration of the study, and be able and willing to comply with all requirements, including treatment, follow-up, and other study procedures as scheduled.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with dementia, gait instability, extrapyramidal signs, seizures, autonomic failure, severe mental illness (major depressive disorder, psychosis, bipolar disorder, schizophrenia), poisoning, conditions affecting cognitive function (severe anemia, thyroid disease, vitamin B12/folate deficiency), positive for syphilis, uncontrolled high blood pressure (systolic/diastolic >=160/100 mmHg or hypotension: systolic = 8% or random blood glucose >= 15 mmol/L during the screening period). 2. Patients with contraindications to hyperbaric oxygen therapy: untreated pneumothorax, rib fractures, chest trauma, cavitary pulmonary tuberculosis, refractory hypertension, severe pneumonia, pulmonary bullae, severe emphysema, asthma, cor pulmonale, inner ear disorders (acute or chronic otitis media, recent middle ear surgery, eustachian tube dysfunction, tympanic membrane perforation, labyrinthitis), claustrophobia, cancer,diabetic proliferative retinopathy, severe heart failure, unstable heart disease. 3. Patients with a history of hyperbaric oxygen therapy.

Design outcomes

Primary

MeasureTime frame
Mini-Mental State Examination, MMSE ;

Secondary

MeasureTime frame
Default Mode Network Functional Connectivity;tau burden;Aß42/Aß40;

Countries

China

Contacts

Public ContactQin Chen

West China Hospital, Sichuan University

chen.qin@scu.edu.cn+86 189 8060 6301

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026