Transcranial random noise treatment for early Alzheimer's disease
Investigating the Effect of Transcranial Random Noise (tRNS) add-on Treatment for Early Alzheimer's Disease
This study is testing if a new brain treatment called Transcranial Random Noise can help people with early Alzheimer's disease improve their thinking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Anhui Medical University Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT05891444 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Transcranial Random Noise (tRNS) on patients with early Alzheimer's disease, focusing on cognitive improvements and underlying neural mechanisms as measured by electroencephalography (EEG). Participants will undergo a series of cognitive assessments and receive either active tRNS or sham treatment over a continuous 14-day period. The study employs a double-blind design, ensuring that neither participants nor clinical raters know which treatment is being administered. Random allocation to treatment groups is achieved through a coin toss, and the study aims to evaluate the efficacy of tRNS in enhancing cognitive function in affected individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with early Alzheimer's disease or related conditions, with a Mini-Mental State Examination (MMSE) score between 10 and 27.
Not a fit: Patients with moderate to severe Alzheimer's disease (CDR score > 2) or those with significant psychiatric or neurological comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel non-invasive approach to improve cognitive function in patients with early Alzheimer's disease.
How similar studies have performed: While the use of tRNS is a relatively novel approach in Alzheimer's treatment, preliminary studies in related areas have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria. * Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia * CDR score ≤ 2 * Subject under treatment by IAChE for at least 3 months. * psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months Exclusion Criteria: * CDR \> 2 * Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder). * History of head injury,stroke,or other neurologic disease. * Organic brain defects on T1 or T2 images. * History of seizures or unexplained loss of consciousness. * Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator. * Family history of medication refractory epilepsy. * History of substance abuse within the last 6 months.
Where this trial is running
Hefei, Anhui
- Anhui Medical University — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Kai Wang, PhD
- Email: wangkai1964@126.com
- Phone: +86-0551-62922263
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.