EEG/ERP Longitudinal Study in Alzheimer's Disease (AD)

Completed

Conditions studied: Alzheimer's Disease

In brief

In a previous study, NCT00582127, two age-matched cohorts, one clinically diagnosed with mild Alzheimer's disease and the other healthy controls, were tested with a hand-held EEG/ERP system to determine if the cohorts could be discriminated using the EEG/ERP measures. This study proposes to retest the AD cohort 18-60 months after their first test to characterize the change in EEG/ERP measures correlated with the longitudinal change in neuropsychological testing.

Key facts

Study ID

NCT02769234

Run by

Neuronetrix, Inc.

People needed

75

Starts

2016-05-01

Expected to finish

2017-07-01

Last updated by the study team

2020-02-26

Who can join

Age: 60 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 60 and 95 years old (inclusive) A diagnosis of Alzheimer's disease A successful ERP/EEG test performed with the COGNISION™ system 2-5 years prior to testing for the current study
• A sub-group of up to 40 subjects will be called back to the sites for follow-up ERP/qEEG and psychometric testing. Additional inclusion criteria for these subjects will be:
• Willing and able to undergo ERP/EEG and psychometric testing
• Have a study partner able to provide an independent evaluation of functioning
• Permitted medications stable for at least 2 weeks prior to testing

You may not qualify if…

• Subjects will not be called back to sites for follow-up testing if they have:
• Known allergy to latex
• Neuropsychological tests administered within three months of study enrollment
• Investigational agents administered within three months of study enrollment
• Severe cognitive and functional deficits that in the judgement of the site PI will prevent them from successfully completing ERP/EEG and/or psychometric testing
• Any significant systemic illness or unstable medical condition at the time of testing which could lead to difficulty complying with the protocol
• Use of psychoactive substances (Gingko Biloba, melatonin, sedatives etc.) will be allowed as long as the subject suspends their use on the day of testing. Smokers will not be required to abstain.

Where it is running

• Premiere Research Institute — West Palm Beach, Florida, United States
• Boston Center for Memory — Brookline, Massachusetts, United States
• The Memory Clinic — Bennington, Vermont, United States

Full record on ClinicalTrials.gov

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