Phase
Condition
Dementia
Treatment
TMS
Transcranial Magnetic Stimulation Sham
Clinical Study ID
Ages 60-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 60-100 at the start of the study
Established diagnosis of Alzheimer's Clinical Syndrome (which is also met through adiagnosis 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 accompanythem to the informed consent visit (this person may be the study partner mentionedabove)
Screening MMSE score of 18-26
Screening GDS score <6
Either 1) treated with memory-enhancing medication (cholinesterase inhibitor) for atleast 2 months, 2) failed trial with no plan to re-trial, or 3) no trial plannedduring 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
Exclusion Criteria:
Participant and/or their surrogate are unwilling or unable to provide informedconsent
Currently pregnant or potentially pregnant
Diagnosis of a dementia or cognitive disorder due to a cause other than Alzheimer'sDisease
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 majorneurologic disorder (e.g., epilepsy, Huntington's disease, Parkinson's disease)
History of seizure disorder or family history of seizure disorder in a first-degreerelative
Poorly-controlled hypertension, cardiovascular disease, or cerebrovascular disease
History of any other major active medical, neurologic, or psychiatric illnessaffecting cognition (associated with cognitive impairment) or a participant'sability 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 unknownmetal in body (including facial tattoos with uknown or metallic inks), surgerywithin 60 days, certain implants (excluding dental fillings), or previous abnormalMRI 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 oractive plans for dose alteration during the course of the study (previouslyunplanned changes that occur during the study will be examined on a case-by-casebasis)
History of treatment with lecanemab, aducanumab, donanemab, or other monoclonalantibody treatment for Alzheimer's Disease (due to lack of knowledge surrounding theimpacts of these treatments)
Currently or within the past 2 weeks taking any of the following classes ofmedication:
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 acase-by-case basis
Antiepileptic agents. While not a strict rule out, this will be decided on acase-by-case basis
Antipsychotic agents. While not a strict rule out, this will be decided on acase-by-case basis
Study Design
Study Description
Connect with a study center
UCLA TMS Clinical and Research Service
Los Angeles, California 90095
United StatesSite Not Available
UCLA TMS Clinical and Research Service
Los Angeles 5368361, California 5332921 90095
United StatesActive - Recruiting

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