AD leads to mild cognitive impairment (MCI):
Conditions
Interventions
Treatment intervention group:Dual-frequency spherical focused ultrasound closed-loop neural regulation system
Sponsors
Chongqing University Three Gorges Hospital(Chongqing Three Gorges Central Hospital)
Eligibility
Sex/Gender
All
Age
45 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis AD leads to mild cognitive impairment (MCI): (1) It meets the core clinical criteria for mild cognitive impairment (MCI) caused by Alzheimer's disease (AD) as defined by the National Institute on Aging-Alzheimer's Association (NIA-AA). (2) At the screening and baseline stages, the Clinical Dementia Rating (CDR) score is 0.5. (3) One year before the screening: A subjective history of gradually developing and slowly progressing memory decline must be reported and confirmed by an informed person. Mild AD dementia: (1) It meets the core clinical criteria for possible Alzheimer's disease dementia as defined by the National Institute on Aging (NIA-AA). (2) At the screening and baseline stages, the Clinical Dementia Rating (CDR) score is 1. 2. AV1-PET/CT assessment of Aß amyloid protein deposition in the brain: If the study participant has undergone an Aß amyloid protein PET examination within 12 months prior to the planned date and the result is positive, this historical examination result can be used for eligibility determination. Historical examination data must be provided to the sponsor. However, if the study participant wishes to participate in this study, this historical imaging data is insufficient for baseline assessment and a new baseline collection and assessment must be conducted. If the study participant has PET/CT Aß amyloid protein imaging data from this center within 3 months before planned treatment, this imaging data, after confirmation by the investigator as qualified, can be used for baseline assessment. 3. Male or female study participants aged >= 45 and <= 85 who have signed the informed consent form. 4. If the study participant is receiving approved Alzheimer's disease (AD) treatment, cholinesterase inhibitors, NMDA receptor antagonists, or a combination of the two, and needs to maintain a stable dose for at least 12 weeks before the baseline. Participants who have not received AD treatment can be included in this study. Unless otherwise specified, study participants must maintain all other (i.e., non-AD-related) allowed concomitant medications at a stable dose for at least 4 weeks before the baseline. 5. At least one study participant support person (defined as a person who can support the study participant during the study and spend at least 4 hours with the study participant every day) must be identified. This person must be willing and able to provide follow-up information about the study participant throughout the study. According to the investigator's opinion, this person must spend sufficient time with the study participant regularly so that the study participant support person can reliably meet the study requirements. The study participant support person does not need to live with the study participant. For study participant support persons who do not live with the study participant, the investigator must be confident that the study participant can be reached by the study participant support person when the study participant support person is not present. If there is doubt about the suitability of the study participant's care arrangement for inclusion, the investigator should discuss this matter with the medical monitor. The study participant support person must personally participate in the visits for the Clinical Dementia Rating (CDR) and Activities of Daily Living (ADL). 6. A written informed consent must be provided. The consent of the study participant (if appl
Exclusion criteria
Exclusion criteria: 1. Exclude participants who have a history of transient ischemic attack (TIA), stroke or seizure within the past 12 months. 2. Exclude participants who have participated in any clinical research within the past 6 months. 3. Exclude participants who have a malignant tumor. 4. Exclude patients who have previously received deep brain stimulation (DBS), transcranial magnetic stimulation (TMS) or other brain neuroregulation treatments. 5. Exclude participants who report a known or suspected history of drug abuse or dependence (benzodiazepines or opioids) or alcohol abuse or dependence. 6. Exclude participants with any other medical condition that is not stable and well-controlled (such as heart, respiratory, gastrointestinal, kidney diseases), and that the investigator believes may affect the safety of the participants or interfere with the assessment of the study. 7. Exclude any immune disorders that are not well-controlled or require biologic agent treatment during the study. 8. Exclude contraindications for MRI scans, including claustrophobia, cardiac pacemaker/defibrillator, ferromagnetic metal implants (such as cranial and cardiac devices, except those approved for MRI scanners). 9. Exclude contraindications for PET/CT scans, known intolerance or allergy to PET/CT Aß detection tracers, including advanced kidney disease. 10. Exclude participants with head skin or soft tissue conditions that affect acoustic coupling: severe scarring, infection, open wounds, subcutaneous emphysema, etc. 11. Exclude participants with a height of >= 2 meters or a weight of >= 135 kilograms. 12. Exclude participants with severe visual or hearing impairments that prevent them from accurately completing psychological measurement tests. 13. Exclude any neurological conditions that may exceed the cognitive impairment caused by Alzheimer's disease (AD), or any other neurodegenerative diseases (such as brain atrophy, dementia, Parkinson's syndrome, amyotrophic lateral sclerosis, motor neuron disease, frontotemporal dementia, Lewy body dementia, multiple system atrophy, etc.). 14. Exclude any mental disorders or symptoms that may interfere with the study procedures (such as hallucinations, severe depression or delusions). 15. Exclude participants with uncontrolled bleeding disorders (including platelet count 1.5). 16. Exclude participants who are known or screened as HIV positive or infected with syphilis. 17. Exclude women who are in lactation or pregnancy (confirmed by positive ß-human chorionic gonadotropin [ß-hCG] or human chorionic gonadotropin [hCG] tests). 18. Exclude participants with a Hamilton Depression Scale (HAMD) score of >= 14 at screening. 19. Exclude other evidence of clinically significant lesions on brain MRI/MRA during the screening period, which may suggest other diagnoses of dementia other than Alzheimer's disease (AD). 20. Other important pathological findings on brain MRI/MRA during the screening period include but are not limited to: (1) brain contusion, brain atrophy, aneurysm, vascular malformation, cerebral vascular stenosis or evidence of infectious lesion; (2) evidence of multiple lacunar infarction or stroke involving major vascular regions or severe small vessels or Fazekas score grade 3 severe leukoencephalopathy; (3) occupying lesion; (4) brain tumor. 21. Exclude participants with thyroid hormone (T3/T4) levels outside the normal range. Other thyroid function test re
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and severity;Difference frequency signal returned at the focal point; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function changes; | — |
Countries
China
Contacts
Public ContactShengli Chen
Chongqing University Three Gorges Hospital(Chongqing Three Gorges Central Hospital)
Outcome results
None listed