NCT06538311 Transcranial Magnetic Stimulation Treatment for Alzheimer's Disease
| NCT ID | NCT06538311 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Massachusetts General Hospital |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-05-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this research study we want to learn more about the effects of non-invasive brain stimulation on memory and brain-network function in cognitively unimpaired older adults and in patients with amnestic mild cognitive impairment (aMCI). This study will use a form of non-invasive brain stimulation called repetitive Transcranial Magnetic Stimulation (rTMS). rTMS will slightly alter activity in an area of your brain that controls memory. Changes resulting from this stimulation will be measured with behavioral tests of memory and general cognition, as well as by taking images of your brain with Magnetic Resonance Imaging (MRI). Participants will come in for one baseline visit followed by 10 days of daily rTMS study visits (Monday through Friday) and an evaluation visit. Then, there will be a 2-week break. After this break, they will return for another baseline visit, an additional 10 days of rTMS, and a final evaluation visit.
Eligibility Criteria
Inclusion Criteria: 1. Between the ages of 40-99 2. Native English speakers 3. Willing and able to consent to the protocol and undergo imaging and neuropsychological testing at the specified time points 4. Patients with PPA will be asked to bring a study partner to all visits 5. Patients with very mild or mild PPA, patients with amnestic mild cognitive impairment and cognitively unimpaired participants with preclinical AD will be included. Exclusion Criteria: 1. History of head trauma involving loss of consciousness or alteration in consciousness 2. Another major neurologic or psychiatric condition 3. Known presence of a structural brain lesion (e.g. tumor, cortical infarct) 4. Any contraindication to MRI, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body 5. Longstanding premorbid history (i.e. longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed 6. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol. 7. Unwilling to return for follow-up, undergo neuropsychological testing, TMS, and MR imaging 8. History of unprovoked seizures (i.e., seizures that occur in the absence of a clear provocation such as hyponatremia, hypoglycemia, etc.). 9. Subjects who have a first degree relative (e.g., father, mother or sibling) with a seizure disorder. 10. Subjects currently taking, or plan to take, medications which are highly epileptogenic. These include: clozapine, high doses of bupropion (i.e., greater than 400mg daily), diphenhydramine, cyclosporine, isoniazid, imipenem, chloroquine, tramadol and theophylline. 11. Subjects actively on anti-amyloid treatments. This is because they are at risk for bleeding due to amyloid-related imaging abnormalities (ARIA) that could provoke seizures.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06538311 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 99 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06538311 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06538311 currently recruiting?
Yes, NCT06538311 is actively recruiting participants. Contact the research team at atouroutoglou@mgh.harvard.edu for enrollment information.
Where is the NCT06538311 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06538311 clinical trial?
NCT06538311 is sponsored by Massachusetts General Hospital. The trial plans to enroll 30 participants.
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