Alzheimer's disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. 55-85 years old (including both ends); 2. MCI or mild dementia due to Alzheimer's disease according to NIA-AA 2018 criteria; 3. An overall CDR score of 0.5 with a CDR of 0.5 in at least one of the three instrumental daily living categories (Personal Care, Family and Hobbies, Community Affairs) or CDR Overall Rating 1.0; 4. RBANS Delayed Memory Index score= 22; 6. Amyloid positivity determined by amyloid PET or CSF Aß1-42 (historical results within 2 years are acceptable); 7. Have a qualified research partner (at least 4 times a week with the subject for a total of at least 10 hours); 8. Anti-AD treatment drugs are stable for 3 months.
Exclusion criteria
Exclusion criteria: 1. Brain MRI or CT scan confirming clinically significant structural central nervous system disease (eg, cerebrovascular disease, previous major hemorrhage, cerebrovascular malformation, cortical hemosiderosis, intracranial aneurysm) as confirmed by radiograph , intracranial tumor, changes suggestive of normal intracranial pressure hydrocephalus); 2. Critical site infarction, defined as bilateral thalamic lacunar infarction and unilateral paramedian thalamic infarction; 3. Evidence of other related neurological disorders, including but not limited to: Parkinson's disease, Lewy body disease, any type of frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, systemic lupus erythema, progressive Supranuclear palsy, neurosyphilis, HIV, learning disabilities, intellectual disability, hypoxic brain injury, and major head trauma with loss of consciousness lead to persistent cognitive impairment; 4. Evidence of clinically significant or unstable mental illness, including schizophrenia or other mental illness or bipolar disorder. Depression in remission or under treatment control was admitted; 5. Negative for amyloid based on Aß PET scan or CSF Aß1-42 within 2 years; 6. Use of prohibited drugs (regular use of moderate or more potent anticholinergic drugs, or benzodiazepines and sedatives within 4 weeks; stimulant drugs within 4 weeks; use of anticholinergic drugs within 3 months Parkinson's drugs,anticonvulsants, antipsychotics, morphine and narcotic analgesics); 7. Abnormal thyroid function, or vitamin B12 or folic acid deficiency; 8. Type 1 diabetes; 9. Type 2 diabetes: uncontrolled or potentially unstable diabetic retinopathy or macular degeneration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The score of CDR-SB;fasting blood sugar;fasting insulin; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood lipids;Adenosine triphosphate;liver function;kidney function;Lactic acid; | — |
Countries
China
Contacts
Union Hospital of Fujian Medical University