Diagnosis of Alzheimer's Disease Using Event Related Potentials

Mild Cognitive Impairment Clinical Trial

Official title:

Diagnosis of Alzheimer's Disease Using Event Related Potentials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02957227
• Other study ID #: 5I01CX000736-02-COG
• Secondary ID: 5I01CX000736-02
• Status: Recruiting
• Start date: July 2016
• Est. completion date: July 2023

Study information

• Verified date: September 2022
• Source: VA Boston Healthcare System
• Contact: Katherine Turk, MD
• Phone: 847-364-2139
• Email: kturk[@]bu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the use of an EEG device using Event Related Potentials to help diagnose Alzheimer's Disease in the outpatient clinical setting.

Description:

The objective of this study is to improve the accuracy of diagnosis of Alzheimer's disease in a clinic setting using an EEG device to measure event related potentials. This study will recruit patients who are being seen with a memory complaint or the first time. It will be prospective in nature. Subjects will initially be evaluated by clinicians and then clinicians will fill out a rating questionnaire as to their level of certainty of various possible dementia diagnoses. Then, during the testing portion of the study, subjects will return to have an EEG test completed measuring event related potentials during an acoustic oddball paradigm task. The EEG will be completed by a technician who has no knowledge of the subject's clinical diagnosis. After the EEG is performed, the data will be evaluated by the study clinician in a blinded fashion. The clinician will log the EEG results as being either consistent with Alzheimer's disease or not. Finally, there will be analysis of the initial clinical rating by clinicians in comparison to a given subject's EEG results and interpretation. This will allow determination as to whether or not the clinical diagnosis was in agreement or disagreement with the EEG data and interpretation. At this time point a second clinician rating questionnaire will be completed to assess the current level of confidence and diagnostic certainty in light of the now revealed EEG data in addition to clinical data. There will also be quantitative analysis of MRI structural data regarding regional atrophy patterns as well as Amyloid PET data for some of the participants which will act as a diagnostic gold standard. An additional aim of this study is to investigate patterns of impairment on memory testing in older adults who are malingering and reporting a memory impairment in the absence of a disorder. This aim will involve testing healthy older adults using EEG and also testing memory impaired older adults with AD and comparing the results, as well as comparing the two groups results on neuropsychologic measures of effort including the Test of Memory and Malingering (TOMM). Impact/Significance: This proposed study could allow for increased accuracy and diagnostic certainty of the correct diagnosis among memory impaired patients and could allow for the incorporation of a new clinical technique, EEG testing among memory impaired patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

Inclusion Criteria: Cohort 1: Older adults with memory impairment: must have a physician or primary caregiver report of memory loss and must be between 50 and 100 years old. cohort 2: Older adults who test normally on neuropsychologic testing and have no history of neurologic disorders. Exclusion Criteria: Lack of reported memory loss by physician or primary caregiver who does not meet age limits.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• No intervention is part of this study but patients use an EEG device during observational data collection.

Locations

Country	Name	City	State
United States	VA Boston Healthcare	Jamaica Plain	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in memory disorder diagnosis	The memory diagnosis will be compared between a purely clinical diagnosis and the diagnosis arrived at through use of the EEG data.	3 years
Secondary	EEG peak amplitude and latency	Will be measured in order to answer the question of whether EEG amplitude and latency are predictive of Alzheimer's disease severity, using regression analysis	3 years
Secondary	Cortical, quantitative MRI volume measurements	MRI volumes will be assessed using quantitative MRI software to assess whether they correlate with EEG amplitude and latency data	3 years
Secondary	Amyloid PET tracer uptake, Standardardized Uptake Value ratios (SUVRs)	Amyloid PET SUVR data will be compared to other outcome measures including EEG results and quantitative MRI as well as final clinical diagnosis.	3 years
Secondary	Mini mental status exam scores	Quantitative results from this neuropsychological test will be used to assess level of cognitive function in subjects and will be correlated with other outcome measures.	3 years
Secondary	Test of Memory and Malingering (TOMM) scores	TOMM scores will be compared between healthy older adults simulating a memory impairment with older adults who have AD. Also both cohorts will undergo EEG testing in order to determine if EEG along with the TOMM helps determine whether older adults are displaying true cognitive impairment, or are malingering.	3 years