Development of a Novel Multidimensional Therapeutic Intervention Protocol for MCI (NCT07196592) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Development of a Novel Multidimensional Therapeutic Intervention Protocol for MCI
300 participantsStarted 2025-10-01
Plain-language summary
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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is measuring olfactory sensitivity and something called 'path integration' — can you explain what those tests involve and why they might be meaningful indicators for my type of early-stage Alzheimer's or MCI?
2Since this trial is listed as 'not yet recruiting,' how far away do you think it realistically is from opening, and would waiting for it delay any standard treatments I should be considering right now?
3The trial doesn't have a traditional phase listed, which I understand might mean it's more of a foundational or exploratory study — what does that mean for what's already known about the safety and effectiveness of whatever intervention they're testing?
4The study uses the MoCA-B to measure cognitive performance — is that a tool you already use with me, and would my current scores suggest I'd be a reasonable candidate to discuss with the research team when enrollment opens?
5Given that this trial targets MCI and early-stage Alzheimer's specifically, do you think my current diagnosis and progression timeline aligns well enough with what they're studying, or are there other trials or standard treatments that might be a better fit for where I am right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Olfactory Sensitivity (TDI score)
Timeframe: Baseline; 30 minutes after Session 1; 30 minutes after Session 5; 30 minutes after Session 10; 1 week after Session 10.
2
Path Integration - Angle Deviation
Timeframe: Baseline; 5 minutes after Session 1; 5 minutes after Session 5; 5 minutes after Session 10.
3
Path Integration - Distance Deviation
Timeframe: Baseline; 5 minutes after Session 1; 5 minutes after Session 5; 5 minutes after Session 10.
4
Path Integration - Composite Accuracy (M_ROC_AUC)
Timeframe: Baseline; 5 minutes after Session 1; 5 minutes after Session 5; 5 minutes after Session 10.