Status:
RECRUITING
Deep Repetitive Transcranial Magnetic Stimulation (rTMS) of the Precuneus for Alzheimer Disease (AD)
Lead Sponsor:
University of California, Los Angeles
Conditions:
Alzheimer's Disease
Alzheimer Disease
Eligibility:
All Genders
60-100 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical trial is to learn if using deep repetitive transcranial magnetic stimulation (rTMS) targeting the precuneus is feasible, tolerable, and potentially efficacious for memory in ...
Detailed Description
This study is designed to examine whether non-invasive electromagnetic stimulation of a specific brain region can help improve memory in the short-term in Alzheimer's Disease (AD). AD is a progressive...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06597942
Start Date
October 17 2024
End Date
October 1 2026
Last Update
January 8 2025
Active Locations (1)
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1
UCLA TMS Clinical and Research Service
Los Angeles, California, United States, 90095