EEG/ERP Longitudinal Study in Alzheimer's Disease (AD)
ERP and qEEG Measures Collected in Outpatient Settings as Indices of Disease Progression in Alzheimer's Disease (AD)
1 other identifier
observational
75
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2016
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2015
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedFirst Posted
Study publicly available on registry
May 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedFebruary 26, 2020
February 1, 2020
1.1 years
February 26, 2015
February 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation (longitudinal change) between EEG/ERP vs. Neuropsychological Testing.
24-60 Months
Secondary Outcomes (2)
Correlation (longitudinal change) between EEG/ERP vs ADNI-EF composite.
24-60 Months
Correlation (longitudinal change) between EEG/ERP vs. ADNI-Mem composite.
24-60 Months
Study Arms (1)
Alzheimer's disease
Subjects with a diagnosis of Alzheimer's disease that successfully performed an ERP/EEG test with the COGNISION(TM) System prior to enrollment for the current study are eligible to participate.
Interventions
The testing protocol consists of an auditory oddball ERP paradigm, followed by the collection of 3min of resting EEG. During the ERP paradigm a variety of auditory stimuli are played through the system's earphones while voltage potentials are recorded from the subject's scalp. At the end of the ERP session, 3 minutes of EEG data will be recorded while the subject is resting. The entire procedure, including set up, instructions to the subject and actual test is expected to take 45-60 minutes.
Subjects that complete ERP/qEEG testing successfully will move on to clinical and neuropsychological evaluation. Demographic information with also be collected.
Eligibility Criteria
AD subjects that successfully completed ERP/EEG testing during NCT00582127.
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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuronetrix, Inc.lead
- Boston Center for Memorycollaborator
- The Memory Clinic of Vermontcollaborator
- Premiere Research Institutecollaborator
Study Sites (3)
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Boston Center for Memory
Brookline, Massachusetts, 02467, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
Related Publications (1)
Cecchi M, Moore DK, Sadowsky CH, Solomon PR, Doraiswamy PM, Smith CD, Jicha GA, Budson AE, Arnold SE, Fadem KC. A clinical trial to validate event-related potential markers of Alzheimer's disease in outpatient settings. Alzheimers Dement (Amst). 2015 Oct 2;1(4):387-94. doi: 10.1016/j.dadm.2015.08.004. eCollection 2015 Dec.
PMID: 27239520BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marco Cecchi, PhD
Neuronetrix, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2015
First Posted
May 11, 2016
Study Start
May 1, 2016
Primary Completion
June 1, 2017
Study Completion
July 1, 2017
Last Updated
February 26, 2020
Record last verified: 2020-02