Diagnosis of Alzheimer's Disease Using Event Related Potentials

NCT02957227 | Unknown DMC

• 2 other identifiers: 5I01CX000736-02-COG5I01CX000736-02
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Alzheimer's disease; Frontotemporal Dementia; Lewy Body Dementia; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• EEG peak amplitude and latency

  3 years

• Cortical, quantitative MRI volume measurements

  3 years

• Amyloid PET tracer uptake, Standardardized Uptake Value ratios (SUVRs)

  3 years

• Mini mental status exam scores

  3 years

• Test of Memory and Malingering (TOMM) scores

  3 years

Study Arms (2)

1

cohort 1: Older adults with memory impairment

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

2

cohort 2: Age matched healthy controls

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

Interventions

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

1; 2

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• cohort 2: Older adults who test normally on neuropsychologic testing and have no history of neurologic disorders.

Sponsors & Collaborators

• VA Boston Healthcare System: lead

Study Sites (1)

VA Boston Healthcare

Jamaica Plain, Massachusetts, 02130, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Frontotemporal Dementia; Lewy Body Disease; Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Katherine Turk, MD

  VA, BU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Turk, MD

CONTACT

847-364-2139; kturk@bu.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: November 7, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)