Alzheimers disease (AD)
Conditions
Interventions
Xenon Treatment Group:Xenon Treatment
Sponsors
The Third People's Hospital of Jinan
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for Alzheimer's disease; 2. Aged >=50 years and <=80 years, regardless of gender; 3. No functional impairment of major organs, with normal heart, liver, and kidney function; 4. Vital signs and physical examination deemed suitable for participation in the study by the investigator; 5. The participant fully understands the purpose and requirements of the trial, voluntarily agrees to participate, and signs the informed consent form together with their legal guardian. If the participant is unable to sign due to cognitive impairment or other reasons, the participant's signature field may be left blank with an explanation provided. The legal guardian must sign in the explanation section, and the legal guardian must also sign the informed consent form; (6) The participant must have a stable and reliable caregiver or at least maintain frequent contact with a caregiver. The caregiver will assist the participant throughout the study, accompany them during research visits, and must have sufficient interaction with the participant to provide meaningful information for scale assessments.
Exclusion criteria
Exclusion criteria: 1. Dementia due to other causes, such as vascular dementia; central nervous system infections (e.g., AIDS and syphilis); Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury-related dementia; chemical factors like drug or alcohol intoxication; significant systemic diseases such as hepatic encephalopathy or pulmonary encephalopathy; subdural hematoma; endocrine disorders such as thyroid or parathyroid diseases; vitamin deficiencies; or dementia due to any other cause. 2. Participation in any drug clinical trial (excluding vitamins and minerals) within 1 month before screening or within 7 half-lives of the drug (whichever is longer), or current participation in another drug clinical trial. 3. Receipt of any vaccination within 4 weeks before screening. 4. History of clinically significant abnormal electrocardiogram (ECG), or QTcF >450 ms at screening or baseline. 5. At screening, resting heart rate (after at least 5 minutes of rest) confirmed in three seated measurements to be below 60 beats per minute. 6. Uncontrolled hypertension or hypotension at screening. Subjects with systolic or diastolic blood pressure slightly outside the range but deemed clinically insignificant by the investigator may be included. 7. Uncontrolled diabetes: fasting blood glucose >=7.0 mmol/L or glycated hemoglobin (HbA1c) >=6.5%; uncontrolled hyperlipidemia: triglycerides >=2.3 mmol/L or cholesterol >=6.2 mmol/L. 8. Occurrence of any of the following within 3 months before dosing: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident (including transient ischemic attack); or history of epilepsy, renal insufficiency, mechanical intestinal obstruction, angina, bradycardia, heart block, chronic obstructive pulmonary disease, or bronchial asthma. 9. Blood donation (including component donation) or significant blood loss (>=200 mL) within 3 months before screening. 10. History of alcohol abuse within 1 year before screening (weekly alcohol intake exceeding 14 units, where 1 unit ˜ 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine), or a positive alcohol breath test. 11. History of drug or substance abuse within 1 year before screening, or a positive drug abuse screening test (including morphine, methamphetamine, methadone, phencyclidine, tetrahydrocannabinol, amphetamine, cocaine, barbiturates, benzodiazepines, tricyclic antidepressants). 12. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis serology (TRUST) during screening. 13. Presence of other poorly controlled clinical conditions (e.g., tumors, HIV infection, syphilis infection, hepatitis C infection, active hepatitis B or other severe chronic infectious diseases, severe neurological, cardiovascular, respiratory system diseases, etc.). 14. Occurrence of an acute illness before interventional treatment. 15. Presence of severe psychiatric disorders, suicide risk, or inability to cooperate with treatment. 16. Any other reason considered by the investigator or sponsor to make the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positron Emission Tomography - Computed Tomography (PET-CT);Mini-Mental State Examination (MMSE);Adverse event;Montreal Cognitive Assessment (MOCA);ADAS-Cog;Serious Adverse Event;Magnetic Resonance Imaging (MRI);Adverse Drug Reaction; | — |
Countries
China
Contacts
Public ContactZhuangbo Mu
The Third People's Hospital of Jinan
Outcome results
None listed