| NCT ID | NCT06095063 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rotman Research Institute at Baycrest |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-11-15 |
| Primary Completion | 2026-10-01 |
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.
This trial targets 30 participants in total. It began in 2023-11-15 with a primary completion date of 2026-10-01.
⚠ 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
Deep transcranial magnetic stimulation (dTMS) is a brain stimulation technique that involves generating a brief magnetic field in a coil that is placed on the scalp. The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation site. The Brainsway dTMS H7-Coil is able to target an area of the brain that has been shown in studies to be linked to greater resilience to cognitive decline. In this study, the investigators will combine dTMS with cognitive training in older adults with subjective cognitive decline (SCD) and examine the effect of this treatment on memory, other cognitive abilities, and mood. In addition, the investigators will examine the combined effects of dTMS and cognitive training on brain activity as measured using electroencephalography (EEG). Approximately 30 older adults from ages 55 to 70 with SCD and a positive family history of Alzheimer's disease will be enrolled in this study.
Eligibility Criteria
Inclusion Criteria: * have a family history of late onset sporadic Alzheimer's disease (AD) as defined by having a first degree relative, living or deceased, with a probable or confirmed diagnosis of AD * have subjective memory decline and concern about memory changes * score 26 or higher on the Montreal Cognitive Assessment (MoCA) * are willing to provide informed consent * are able to follow the treatment schedule * are stable on medications for 2 months and are not expected to change medication during the entire study period (if they are taking medications) * have a satisfactory safety screening questionnaire for TMS * have an informant/study partner who is able to complete study questionnaires regarding the participant Exclusion Criteria: * have a metal plate in their head, except in the mouth (such as an ear implant, implanted brain stimulators, aneurysm clips) * have known increased pressure or a history of increased pressure in their brain, which may increase their risk for having seizures * have a cardiac pacemaker * have an implanted medication pump * have a central venous line * have a significant heart condition * have current depression or a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia other than AD * have a history of substance abuse in the last 6 months * have a history of stroke or other brain lesions * have a personal history of epilepsy * have a family history of epilepsy * are a pregnant or breast-feeding woman * have a history of abnormal MRI of the brain * have significant hearing loss requiring use of hearing aids * have untreated hypo- or hyper-thyroidism * have TMS contraindications * have unstable medical condition(s) * regularly use benzodiazepines or other hypnotics within 2 weeks of randomization
Contact & Investigator
Linda Mah
PRINCIPAL INVESTIGATOR
Baycrest Rotman Research Institute
Frequently Asked Questions
Who can join the NCT06095063 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 70 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.
Is NCT06095063 currently recruiting?
Yes, NCT06095063 is actively recruiting participants. Contact the research team at dtms@research.baycrest.org for enrollment information.
Where is the NCT06095063 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06095063 clinical trial?
NCT06095063 is sponsored by Rotman Research Institute at Baycrest. The principal investigator is Linda Mah at Baycrest Rotman Research Institute. The trial plans to enroll 30 participants.
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