Evidence Amyloid Scan EEG Study
Status unconfirmed
Conditions studied: Alzheimer Disease, Dementia Frontal, Mild Cognitive Impairment
In brief
The Evidence Amyloid Study EEG (EASE) establishes an open-label, longitudinal cohort study to measure of neurological functioning during the onset and progression of cognitive decline in preclinical Alzheimer's patients using quantitative electroencephalography (qEEG) measures (P300, P50, and reaction time). Participants will be scanned using the ElectroCap (FDA Class II) and/or the WAVi headset with the WAVi EEG P300/P50 system, along with the structured clinical interviews and assessments for baseline screening or mild cognitive impairment which are standard of care.
Key facts
- Study ID
- NCT03644043
- Run by
- Metabolic Therapy Inc.
- People needed
- 2000
- Starts
- 2018-07-20
- Expected to finish
- 2020-11-30
- Last updated by the study team
- 2018-08-23
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 65 and older;
- Medicare beneficiary;
- Diagnosis of MCI or dementia, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months (American Psychiatric Association. 2000; McKhann et al. 2011; Albert et al. 2011);
- Cognitive complaint verified by objectively confirmed cognitive impairment;
- Alzheimer's disease is a diagnostic considerationExclusion Criteria:
- Head MRI and/or CT within 24 months prior to enrollment;
You may not qualify if…
- Normal cognition or subjective complaints that are not verified by cognitive testing.
- Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family.
- Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening).
- Cancer requiring active therapy (excluding non-melanoma skin cancer);
- Life expectancy less than 24 months based on medical co-morbidities;
- Residence in a skilled nursing facility.
Where it is running
- Translational Cognitive Research — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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