Reducing long-term memory loss in older adults with mild cognitive impairment
Diminishing Accelerated Long-term Forgetting in Mild Cognitive Impairment: Study Protocol for a Prospective, Double-blind, Placebo-controlled, Randomized Controlled Trial
This study is testing if a special type of electrical stimulation can help improve memory in older adults with mild cognitive impairment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Dublin, Trinity College Academic / other |
| Locations | 1 site (Dublin) |
| Trial ID | NCT05289804 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of non-invasive electrical stimulation on patients with amnestic mild cognitive impairment (aMCI). Conducted at St. James' Hospital and Trinity College Dublin, the study will involve 100 participants who will be randomly assigned to one of four groups: one receiving active stimulation, one receiving sham stimulation, one receiving stimulation with local anesthesia, and one receiving stimulation of a different nerve. The study is designed to ensure that any observed effects are specific to the targeted nerve and not due to other sensations. The goal is to determine if this intervention can significantly improve memory function in older adults with aMCI.
Who should consider this trial
Good fit: Ideal candidates for this study are English-speaking individuals aged 50 and above with a confirmed diagnosis of amnestic mild cognitive impairment.
Not a fit: Patients with cognitive decline due to causes other than Alzheimer's disease or those with significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help improve memory retention in patients with mild cognitive impairment, potentially delaying the progression to more severe forms of dementia.
How similar studies have performed: While similar approaches using electrical stimulation have shown promise in other studies, this specific intervention is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥50 years * Diagnosis of probable aMCI or mild AD * Montreal Cognitive Assessment between 18-25 * Mini Mental State Examination score \>21 * Stable AChl medication \>3 months * Adequate visual and auditory acuity * Capacity to understand and sign informed consent Exclusion Criteria: * Any cause of cognitive decline or dementia that is not Alzheimer's disease related including parkinsonism related dementias, vascular dementia, fronto-temporal dementia. * Enrolment in an ongoing investigational medicinal product study * History in the past 2 years of epileptic seizures * Any current major psychiatric disorder * Evidence of brain damage, including significant trauma, stroke, hydrocephalus, intellectual disability, or serious neurological disorder. * History of alcoholism or drug abuse within the last 12 months * Medical devices not eligible for MRI scanning
Where this trial is running
Dublin
- Tcin — Dublin, Ireland (Recruiting)
Study contacts
- Principal investigator: Sven Vanneste, PhD — University of Dublin, Trinity College
- Study coordinator: Sven Vanneste, PhD
- Email: sven.vanneste@tcd.ie
- Phone: +35318968521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.