Deep Repetitive Transcranial Magnetic Stimulation (rTMS) of the Precuneus for Alzheimer Disease (AD)

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Sep 13, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether a treatment called deep repetitive transcranial magnetic stimulation (rTMS) can help improve memory in people with Alzheimer's disease. The researchers want to find out if this treatment is safe, if it can cause positive changes in the brain, and if it might actually help with memory. Participants in this trial will undergo memory tests, brain scans, and blood tests. They will come to the clinic for a total of 12 treatment sessions over a few weeks, followed by additional sessions for maintenance. If someone initially receives a placebo (a treatment that looks like the real one but has no effect), they will still have the chance to receive the actual treatment afterward.

To be part of the trial, participants need to be between 60 and 100 years old and have a diagnosis of Alzheimer's. They should also have a caregiver who can accompany them to all visits. Other important requirements include being stable on memory-enhancing medication for at least two months and not having severe cognitive issues that would prevent them from participating. Overall, this study is looking for ways to potentially improve memory and quality of life for individuals living with Alzheimer's disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 60-100 at the start of the study
• • Established diagnosis of Alzheimer's Clinical Syndrome (which is also met through a diagnosis of Alzheimer's Dementia)
• • Agreement to participate in study and able to complete informed consent process
• • Have a caregiver/study partner who can accompany them to all study visits
• • Have a known alternate surrogate decision-maker (in case needed) who can accompany them to the informed consent visit (this person may be the study partner mentioned above)
• • Screening MMSE score of 18-26
• • Screening GDS score \<6
• • Either 1) treated with memory-enhancing medication (cholinesterase inhibitor) for at least 2 months, 2) failed trial with no plan to re-trial, or 3) no trial planned during the course of the study for other reasons
• • No change in use of psychotropic medication for the treatment of depression, anxiety, ADHD, or psychosis for 2 weeks prior to the study
• Exclusion Criteria:
• • Participant and/or their surrogate are unwilling or unable to provide informed consent
• • Currently pregnant or potentially pregnant
• • Diagnosis of a dementia or cognitive disorder due to a cause other than Alzheimer's Disease
• • Diagnosis of severe Dementia (CDR \> 2.0) at the start of the study
• • History of substance use disorder currently not in sustained remission
• • Substance misuse within the past 6 months (excluding nicotine or caffeine)
• • History of stroke, traumatic brain injury with loss of consciousness, or other major neurologic disorder (e.g., epilepsy, Huntington's disease, Parkinson's disease)
• • History of seizure disorder or family history of seizure disorder in a first-degree relative
• • Poorly-controlled hypertension, cardiovascular disease, or cerebrovascular disease
• • History of any other major active medical, neurologic, or psychiatric illness affecting cognition (associated with cognitive impairment) or a participant's ability to safely and meaningfully participate in the study
• • Non-fluent in English (not native or functionally-native)
• • Contraindication to TMS or MRI including claustrophobia, MRI-incompatible or unknown metal in body (including facial tattoos with uknown or metallic inks), surgery within 60 days, certain implants (excluding dental fillings), or previous abnormal MRI results.
• • Has previous history of TMS treatment in the past (not TMS naïve)
• • Currently enrolled in a memory-enhancement study
• • Alteration in cognitive-enhancement medication dose within the past 2 months or active plans for dose alteration during the course of the study (previously unplanned changes that occur during the study will be examined on a case-by-case basis)
• • History of treatment with lecanemab, aducanumab, donanemab, or other monoclonal antibody treatment for Alzheimer's Disease (due to lack of knowledge surrounding the impacts of these treatments)
• * Currently or within the past 2 weeks taking any of the following classes of medication:
• • Anticholinergic (e.g., tolterodine, benztropine)
• • Sedating antihistamines (e.g., diphenhydramine)
• • any drug that has significant anticholinergic or antihistaminic side effects (e.g., tricyclic antidepressant medications, mirtazapine).
• • Benzodiazepines. While not a strict rule out, this will be decided on a case-by-case basis
• • Antiepileptic agents. While not a strict rule out, this will be decided on a case-by-case basis
• • Antipsychotic agents. While not a strict rule out, this will be decided on a case-by-case basis