Mild cognitive impairment
Conditions
Interventions
Mild to moderate cognitive impairment group:None
Sponsors
Hunan Hospital of Integrated Traditional Chinese and Western Medicine (Affiliated Hospital of Hunan Academy of Chinese Medicine)
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: (1) MCI diagnosis meets Petersen's criteria; (2) Age: 55-85 years old (including both 55 and 85 years old), gender not limited; (3) MMSE=23 points (Baseline dementia diagnosis was based on the MMSE education adjustment value: =26 points for university, =24 points for middle school, and =23 points for primary school); (4) The visual score scale for medial temporal lobe atrophy (MTA) on coronal MRI of the head was =1.5 points (age-adjusted values were used: =1.0 points for 55-64 years old, =1.5 points for 65-74 years old, and =2.0 points for 75-84 years old). (5) High-risk evidence for AD: Positive urine Aß test (three retests) (supporting evidence after inclusion, for stratified analysis of therapeutic effect); (6) The patient has sufficient vision and hearing to participate in the clinical assessment, has normal swallowing function and is capable of completing the medication. (7) Be able to read simple articles and write simple sentences; (8) Have a stable caregiver; (9) Informed consent: The guardian shall sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Has been diagnosed with dementia (MMSE 0-22 points); (2) There is vascular cognitive impairment, frontotemporal dementia, Parkinson's disease dementia, Lewy body dementia, Huntington's disease, subdural hematoma, communicating hydrocephalus, brain tumor, thyroid disease, vitamin deficiency or other diseases that may cause cognitive impairment, or severe brain infection diseases (including neurosyphilis, meningitis or encephalitis), etc. (3) There are unstable mental disorders, including major depressive disorder (HAMD=17), major anxiety disorder (HAMA=12 points), bipolar disorder, schizophrenia, etc. (4) Has a history of alcohol abuse or drug abuse within the past five years; (5) Other poorly controlled systemic diseases, such as severe arrhythmias (ventricular rate 100 beats per minute, or patients who have experienced myocardial infarction within 3 months prior to participating in the trial, or severe heart failure (NY classification III and IV), or severe blood pressure abnormalities, systolic blood pressure =90mmHg or =180mmHg; (6) Antibiotics or probiotics have been used in the past three months; (7) Combined with intestinal diseases such as irritable syndrome; (8) Currently undergoing cognitive improvement medication or Receiving drugs that affect the central nervous system, such as antidepressants, benzodiazepines, etc., with a stable dose for less than 4 weeks (but those with a stable dose of =4 weeks can be enrolled); (9) Any of the following manifestations are presented on cranial MRI: more than 4 microbleeds in the brain; There was previous evidence of massive intracranial hemorrhage; More than 3 lacunar infarction foci (each larger than 10mm); Any cortical infarction larger than 10mm; Extensive and fused white matter lesions (white matter score of grade 3); Other imaging evidence: including brain tumors, arteriovenous malformations or cavernous hemangiomas; (10) Those with metal (ferromagnetic) implants or pacemakers, etc., as well as others who cannot undergo MRI examinations; (11) The researcher believes that there are other circumstances that make participation in this clinical trial unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI FLAIR sequence; | — |
Secondary
| Measure | Time frame |
|---|---|
| T1-weighted cranial MRI;T2-weighted cranial MRI;MoCA; | — |
Countries
China
Contacts
Public ContactWang Yahan
Hunan Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed