NCT07196592Not yet recruiting
Development of a Novel Multidimensional Therapeutic Intervention Protocol for MCI
AD New Multi-Dimensional Therapy Device Development - Microcurrent Brain Stimulation Device and Virtual Reality Therapy Equipment
Source: ClinicalTrials.gov · Last updated 29 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
As populations age, Alzheimer's disease (AD) is increasing while disease-modifying drugs remain elusive, making early diagnosis and intervention essential. Building on advances in neuromodulation and virtual reality (VR), we target amnestic mild cognitive impairment (aMCI)-the prodromal stage of AD-as a key window for prevention. Preliminary evidence shows disrupted theta-delta phase-amplitude coupling in prefrontal and temporal cortices in aMCI, whereas olfactory enrichment can enhance hippocampal synaptic function, improve cognition, and potentially lower AD risk. We will conduct a large-scale clinical cohort study to test the neural mechanisms and clinical efficacy of multi-site, cross-frequency transcranial alternating current stimulation (tACS) combined with multisensory (visual-olfactory-auditory) VR. A comprehensive database spanning demographic, neuropsychological, biochemical, neuroimaging, and neuromodulation parameters will guide optimal protocols and provide objective evidence for non-pharmacological interventions, informing development of a microcurrent brain stimulator and a portable VR device.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 15 Sept 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Yuan Shen
- Diseases
- Alzheimer disease
- NCT number
- NCT07196592
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 1 Oct 2025 to the primary completion date, 1 Nov 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Baseline screening exclusion criteria: a) Neurological/psychiatric disorders affecting cognitive function: depression, schizophrenia, mental retardation, Parkinson's disease, etc.; b) Severe physical illnesses: cardiovascular disease, cerebrovascular disease, tumors, diabetes, kidney disease, and hypertension stage III or above; c) Autoimmune inflammatory diseases such as rheumatoid arthritis, lupus erythematosus, osteoarthritis, and multiple sclerosis.
Who the study is looking for
- Baseline screening inclusion criteria: a) Age ≤ 65 years and ≤ 85 years; b) Education duration ≥ 1 year; c) Normal cognitive function at enrollment: MMSE total score: non-illiterate (primary school or below) ≥ 20 points, primary school or above ≥ 24 points; d) Corrected vision and hearing are basically normal, and able to complete cognitive assessment.
Age in the registry: 60 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.