Clinical trial NCT02957227: Diagnosis of Alzheimer's Disease Using Event Related Potentials
Official title: Diagnosis of Alzheimer's Disease Using Event Related Potentials
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment
Keywords: Alzheimer's disease
Frontotemporal Dementia
Lewy Body Dementia
Diagnosis
Lead sponsor: VA Boston Healthcare System
Sponsor class: FED
First posted: 2016-11-06
Enrollment: 170
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a memory disorder based on caregiver or referring clinician report who are being seen in the memory disorders clinic for the first time as well as age-matched older healthy controls without a neurologic condition.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in memory disorder diagnosis
timeFrame: 3 years
Secondary outcomes:
measure: EEG peak amplitude and latency
timeFrame: 3 years
measure: Cortical, quantitative MRI volume measurements
timeFrame: 3 years
measure: Amyloid PET tracer uptake, Standardardized Uptake Value ratios (SUVRs)
timeFrame: 3 years
measure: Mini mental status exam scores
timeFrame: 3 years
measure: Test of Memory and Malingering (TOMM) scores
timeFrame: 3 years
Other outcomes:
Locations:
city: Jamaica Plain
country: United States
facility: VA Boston Healthcare
state: Massachusetts
Study officials:
affiliation: VA, BU
name: Katherine Turk, MD
role: PRINCIPAL_INVESTIGATOR
References: