Pulsed Electromagnetic Field Treatment In Patients With Alzheimer's Disease
ConditionAlzheimer Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-100
SponsorHerrick Medical LLC
About this trial
An open label pilot study in mild to moderate AD patients to assess the effects of treatment with ECHS AD pulsed electromagnetic treatment device on disease progression. Enrolled patients will receive active devices. They will treat themselves at home three times a day for 15 minutes over 120 days. Primary end points are the The Alzheimer's Disease Assessment Scale-Cognitive Subscale and the Mini-Mental State Exam. Participants will be followed-up for 9 months post-treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 50 years
Patients diagnosed with mild to moderate Alzheimer's Dementia defi
At least an eighth grade of educational achievement
If female, post-menopausal.
Disqualifiers
The patient lacks capacity to consent to study participation and no surrogate is available to provide consent
History of epileptic seizures or epilepsy
Currently taking medication that lowers the seizure threshold
Presence of depression, bipolar disorder, a psychotic disorder, or any other neurological or psychiatric condition (whether now or in the past), which the Investigator finds as interfering with the study
Trial design
Design model
Single group
Treatments tested in this trial
ECHS AD Device
DevicePulsed electromagnetic therapy device
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Active ECHS AD deviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Assessment consisting of 11 tasks, taking up to 30mins, to measure the severity of cognitive dementia symptoms. Score 0-70, Higher number, more severity.
Time frame
Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days2
Mini-Mental Status Exam (MMSE)
Clinician assessment of cognitive impairment. Scoring 0-30, lower score, more severity
Time frame
Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days3
Global Deterioration questionnaire
Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity
Time frame
Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days4
Quality of Life Scale
Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity
Time frame
Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Herrick Medical LLC
Lead sponsor
Hackensack Meridian Health
Collaborator
Source ClinicalTrials.gov