Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
- Must speak English fluently
- Diagnosis of MCI as defined by:
- Clinical diagnosis by a neurologist
- Neuropsychological testing support of MCI
- Meet criteria for MCI
- Subjective cognitive decline reported by participant and/or an informant
- Objective memory impairment in one or more cognitive domains for age
- Essentially preserved general cognitive function
- Largely intact functional activities
- Does not meet criteria for dementia as judged by a clinician
- Eligible for transcranial magnetic stimulation (TMS) based on safety criteria
- Clinical Dementia Rating=0.5
- Geriatric Depression Scale score less than 6
- Medically stable and in good general health
- Not pregnant, lactating, or of childbearing potential
- Stable medication regimen for at least 4 weeks prior to baseline visit
- Adequate visual and auditory abilities to complete neuropsychological testing
- Ability to provide informed consent
- Have a care partner who is available to accompany the participant to study visits for
the duration of the protocol.
Exclusion Criteria:
- Inability to communicate in the English language
- Meet criteria for dementia
- Contraindications to TMS or MRI, including patients who have
- conductive, ferromagnetic or other magnetic-sensitive metals implanted in their
head or within 30 cm of the treatment coil (e.g., cochlear implants, implanted
electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments or
jewelry)
- active or inactive implants, including deep brain stimulators, cochlear implants,
vagus nerve stimulators or implanted device leads
- Any true positive findings on the TMS safety screening form
- Prior exposure to TMS, electroconvulsive therapy (ECT), or any neurostimulation within
the past 12 months
- History of epilepsy or seizures
- Medical conditions or use of medications that increase risk of seizures
- History of traumatic brain injury
- History of intracranial mass or lesion
- History of stroke, including hemorrhagic stroke and ischemic stroke
- Medications associated with seizures (Examples: Analgesics - Opioids (e.g.,
meperidine, tramadol); Anti-amyloid immunotherapy such as aducanumab;
Antimicrobials - Carbapenems (e.g., imipenem), Cephalosporins (fourth
generation), Fluoroquinolones (e.g., ciprofloxacin), Isoniazid, Penicillins;
Hypoglycemic agents; Immunosuppressants - Azathioprine, Cyclosporine,
Mycophenolate, Tacrolimus; Psychiatric medications - Antipsychotics, Atomoxetine,
Bupropion, Buspirone, Lithium, Monoamine oxidase inhibitors; Pulmonary drugs -
Aminophylline, Theophylline; Stimulants - Amphetamines, Methylphenidate;
Sympathomimetics and decongestants - Anorexiants (e.g., diethylpropion,
phentermine, nonprescription diet aids), Phenylephrine, Pseudoephedrine.)
- Psychiatric disorders
- Primary psychotic disorder (schizophrenia, schizoaffective, or schizophreniform
disorder), any history
- Primary mood disorder (major depressive disorder, bipolar disorder) within the
past 12 months
- Substance use disorder (except caffeine and nicotine) within the past 12 months
- Active symptoms of depression, anxiety, mania, psychosis, or substance use (except
caffeine and nicotine) within the past year
- Active symptoms of depression will be identified based on geriatric depression
scale ≥ 6
- Other active symptoms of psychiatric conditions to be determined by study
investigators
- Sleep disorders that are considered clinically significant and not sufficiently
treated by the investigative team, including untreated obstructive sleep apnea
(apnea-hypopnea index >15), untreated/suboptimally treated REM sleep behavior
disorder, untreated/suboptimally treated restless legs syndrome
- Pregnancy or suspected pregnancy
- Participation in another concurrent interventional clinical trial
- Any unstable medical condition
- Inability to provide informed consent
- Inability to adhere to the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.