cognitive impairment
Conditions
Interventions
Intervention group1:The left DLPFC was stimulated in the first week and the left hippocampus in the second week. The total current of both pairs of electrodes was 4mA, 30min each time, 2 times a day,
Intervention group2:The left hippocampus was stimulated in the first week and the left DLPFC was stimulated in the second week. The total current of both pairs of electrodes was 4mA, 30min each time,
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: Study participants participating in this clinical trial must meet all of the following criteria: (1) Age =50 and =75 years old and education =4 years, gender is not limited; (2) Patients with mild and moderate AD who meet the diagnostic criteria for AD proposed by the National Institute on Aging and the Alzheimer's Association (NIA-AA) in 2018 and have a disease course of more than 6 months: Evidence of Aß deposition biomarkers (PET with abnormal amyloid deposition or low cerebrospinal fluid Aß42 or Aß42/Aß40 ratio) and tau markers (CSF or PET); (2) Alzheimer's clinical syndrome: there is a single or multiple cognitive domain of cognitive impairment, can be a typical change of memory impairment, can also be manifested as a variant of cognitive dysfunction syndrome; neurobehavioral symptoms: Symptoms that manifest as mood or behavioral disorders, such as anxiety, depression and apathy. (3) For patients with mild and moderate AD, the total score of the MMSE is =26 points (11 points = university =26 points, 11 points = middle school =24 points, 11 points = primary school =23 points); (4) 1= the Clinical Dementia Rating Scale (CDR-GS)=2; (5) Voluntarily sign informed consent, understand and accept the duration of the study, and be able and willing to comply with all requirements, including scheduled treatment, follow-up, and other study procedures.
Exclusion criteria
Exclusion criteria: (1) Cognitive impairment due to conditions such as frontotemporal degeneration, vascular dementia (excluding mild vascular cognitive impairment related to risk factors), normal pressure hydrocephalus, and other disorders (e.g., traumatic brain injury or surgery, infections, immune disorders, tumors, toxicity, and metabolic diseases); (2) Presence of, or a history of, Parkinson's disease or psychiatric disorders such as schizophrenia, bipolar disorder, severe depression, or anxiety; (3) Severe dysfunction of major organs (heart, lungs, liver, kidneys), including severe cardiovascular diseases (hospitalization for myocardial infarction or cardiac surgery within the past three months, congestive heart failure, serious unstable arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysms, etc.), serious pulmonary diseases (such as severe pneumonia, respiratory failure), liver dysfunction (transaminases exceeding three times the normal upper limit), renal impairment (creatinine or urea nitrogen exceeding 1.5 times the normal upper limit), and malignancies, deemed unsuitable for participation in this clinical trial by the investigator; (4) Regular use of cognitive-enhancing medications (e.g., nootropics, ergot alkaloids, calcium channel antagonists, ginkgo biloba extract, cholinesterase inhibitors, ionotropic glutamate receptor antagonists) for six weeks prior to screening, achieving steady state, with no intention to alter the medication regimen (e.g., type, dosage) during the trial; (5) Use of medications targeting Aß amyloid plaque deposition, such as Leqembi, within the past year or currently; (6) Prior implantation of metal objects or devices in the body (excluding dental metal implants), such as cardiac pacemakers or defibrillators, drug pumps, neurostimulators, or cochlear implants; Presence of active skin lesions or inflammation at the site of electrode contact, such as herpes, eczema, or psoriasis; (7) Visual, auditory, language, or reading impairments that would prevent the completion of treatment and assessment; (8) Substance abuse or alcohol dependence within six months prior to screening; (9) Participation in other clinical trials within three months prior to enrollment in this study, or currently involved in other clinical trials; (10) Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in the Alzheimer's Disease Assessment Scale-Cognitive Component (ADAS-cog) score at the end of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Alzheimer's Disease Assessment Scale-Cognitive Component (ADAS-cog) scores from baseline at 4 weeks after treatment;Changes in Clinical Dementia Rating Scale (CDR) scores from baseline after treatment and 4 weeks after treatment;Changes in the Simple Cognitive Function Rating Scale (MMSE) score from baseline after treatment and 4 weeks after treatment;Changes in Montreal Cognitive Assessment Scale (MoCA) scores from baseline after treatment and 4 weeks after treatment;Changes in Pittsburgh Sleep Quality Index (PSQI) scores from baseline after treatment and at 4 weeks after treatment;Changes from baseline in the Generalized Anxiety Disorder Scale-7 (GAD-7) score after treatment and at 4 weeks after treatment;Changes in Patient Health Survey Scale-9 (PHQ-9) scores from baseline after treatment and 4 weeks after treatment;Changes in patients' PET-MRI from baseline at the end of treatment;Changes in patients' MRI from baseline at the end of treatment;Changes of EEG from baseline after treatment and 4 weeks after treatment;HRV changes from baseline;Changes of gastric electrical indices from baseline;Changes in eye movement indicators from baseline; | — |
Countries
China
Contacts
Public ContactLei Chen
West China Hospital, Sichuan University
Outcome results
None listed