Phase
Condition
Alzheimer's Disease
Memory Loss
Vascular Dementia
Treatment
ECHS AD Device
Clinical Study ID
Ages 50-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 50 years 2.2. Patients diagnosed with mild to moderate AD/ADRD includingAlzheimer's disease, Lewy body dementia, and Vascular dementia - defined as a globalCDR of 0.5 or 1 at baseline.
At least an eighth grade of educational achievement 4. If female, post-menopausal.
MMSE score between 16 and 26 (inclusive) 6. Capable of providing consent orhaving a surrogate (e.g., spouse, family member) capable of providing consent ifparticipant lacks consent capacity 7. Able and willing to comply with the protocol
If the participant is receiving a cholinesterase inhibitor and/or memantine, suchmedication has been prescribed for at least 3 months prior to screening and the doseis stable for at least 60 days prior to screening (that dose needs to be maintainedthroughout the period of this study) 10. Physical clearance for study participationas evaluated by the clinician
Exclusion
Exclusion Criteria:
The patient lacks capacity to consent to study participation and no surrogate isavailable to provide consent
The patient does not have a study partner who would be available for interview
History of epileptic seizures or epilepsy
Has Frontotemporal Dementia
Currently taking medication that lowers the seizure threshold, excluding bloodthinners
Is currently taking anti-amyloid monoclonal antibodies (past treatment is allowed iftermination of treatment occurred at least 3 months prior to the baseline visit).
Presence of depression, bipolar disorder, a psychotic disorder, or any otherneurological or psychiatric condition (whether now or in the past), which theInvestigator finds as interfering with the study
Severe agitation that would interfere with study procedures
Alcoholism or substance use disorder as defined by Diagnostic and Statistical Manualof Mental Disorders, Fifth Edition (DSM-5) within last 5 years (addicted more thanone year and or in remission less than 3 years) or severe sleep deprivation
Major surgery (defined as any major abdominal, vascular or thoracic surgeryrequiring general anesthesia and resulting in a period of >1 week hospitalization)within 4 weeks
Head anatomy that interferes with the fit of the treatment device
Participation in another clinical trial within the previous 30 days
Metal implants in the head, (i.e., cochlear implants, implanted brain stimulatorsand neurostimulators, aneurysm clips) with the exception of metal implants in mouth
Criteria to exclude participants from the blood draw study:
Any condition that may significantly increase risks associated with blood draws
Study Design
Connect with a study center
University of Miami
Boca Raton, Florida 334233
United StatesActive - Recruiting
Hackensack Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
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