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| Name | Class |
|---|---|
| University of Miami | OTHER |
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An open label pilot study in mild to moderate AD/ADRD patients to assess the effects of treatment with ECHS AD/ADRD 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 point is the The Alzheimer's Disease Assessment Scale-Cognitive Subscale. Participants will be followed-up for 9 months post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active ECHS AD device | Experimental | Experimental intervention arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECHS AD Device | Device | Pulsed electromagnetic therapy device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change between day 0, and 45, 90, 135, 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Mental Status Exam (MMSE) | Clinician assessment of cognitive impairment. Scoring 0-30, lower score, more severity | Change between day 0, and 45, 90, 135, 180 days |
| Quality of Life Scale | Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity |
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Inclusion Criteria:
1. Age ≥ 50 years 2.2. Patients diagnosed with mild to moderate AD/ADRD including Alzheimer's disease, Lewy body dementia, and Vascular dementia - defined as a global CDR of 0.5 or 1 at baseline.
3. At least an eighth grade of educational achievement 4. If female, post-menopausal. 5. MMSE score between 16 and 26 (inclusive) 6. Capable of providing consent or having a surrogate (e.g., spouse, family member) capable of providing consent if participant lacks consent capacity 7. Able and willing to comply with the protocol 8. If the participant is receiving a cholinesterase inhibitor and/or memantine, such medication has been prescribed for at least 3 months prior to screening and the dose is stable for at least 60 days prior to screening (that dose needs to be maintained throughout the period of this study) 10. Physical clearance for study participation as evaluated by the clinician
Exclusion Criteria:
Any condition that may significantly increase risks associated with blood draws
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magdalena Tolea, PhD | Contact | 561-869-6810 | mit38@med.miami.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Boca Raton | Florida | 334233 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D020961 | Lewy Body Disease |
| D015140 | Dementia, Vascular |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Active treatment
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| Change between day 0, and 45, 90, 135, 180 days |
| Global Deterioration questionnaire | Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity | Change between day 0, and 45, 90, 135, 180 days |
| Side-Effects Questionnaire | Self-report of side-effects | Change between day 0, and 45, 90, 135, 180 days |
| Clinical Dementia Rating (CDR) sum of boxes (CDR-SB) | CDR-SB assesses the severity and progression of dementia | Change between day 0, and 90, 180 days |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |