Back to results48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease
Primary Purpose
Early Onset Alzheimer Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer assisted ambulatory electroencephalogram
Sponsored by
About this trial
This is an interventional basic science trial for Early Onset Alzheimer Disease
Eligibility Criteria
Inclusion criteria for EOAD patients will be recruited from the LEADS trial with the following:
- 40 to 64 years of age
- Meets NIA-AA criteria for mild cognitive impairment (MCI) due to AD or probable AD dementia.
- Have a global CDR score of ≤ 1.0
- Have capacity to provide informed consent (ICF) or has a legal authorized representative or guardian who provides IC.
- Amyloid positive status (PET scan with evidence of elevated amyloid)
- Must have a study partner (informant) who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, and caregiver) who is generally aware of the participants' daily activities and can provide information about the participant's cognitive and functional performance. If the participant does not have a study partner who spends 10 face-to-face hours per week, other arrangements for identifying a viable study partner will be granted on a case-by-case basis by the Site PI.
- Not pregnant or lactating. Women must be two years post-menopausal, be surgically sterile, or have a negative pregnancy test prior to each PET scan
- Fluent in English.
Exclusion Criteria:
- Meets core clinical criteria for non-AD dementia.
- Two or more first degree relatives with a history of EOAD suggestive of autosomal dominant transmission, unless known pathogenic mutations in APP, PSEN1, PSEN2 have been excluded.
- Known mutation in an ADAD gene (APP, PSEN1, PSEN2) or other autosomal dominant genes associated with other neurodegenerative disorders.
- MRI scans with evidence of infection or focal lesions, cortical strokes, multiple lacunes (single lacune is allowable unless it meets criteria for strategic lacune affecting cognition)
- Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol (at the discretion of the Site PI)
- Medical history of a brain disorder other than the disorder causing dementia except for headache.
- Deemed ineligible by the Site PI for any other reason.
Sites / Locations
- Mayo Clinic in FloridaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Early-onset Alzheimer's disease (EOAD) subjects
Arm Description
Subjects with mild cognitive impairment due to EOAD will undergo a 48 hour computer assisted ambulatory electroencephalogram
Outcomes
Primary Outcome Measures
Electrographic seizures: Number of subjects with electrographic seizures
Number of subjects with electrographic seizures in 48 hours on computer assisted ambulatory EEG
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04002583
Brief Title
48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease
Official Title
A Prospective Study Evaluating the Use of 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers are trying to determine the frequency of seizures and epilepsy in patients with Early-onset Alzheimer's disease (EOAD) using a 48-hour computer assisted ambulatory electroencephalogram.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Onset Alzheimer Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early-onset Alzheimer's disease (EOAD) subjects
Arm Type
Experimental
Arm Description
Subjects with mild cognitive impairment due to EOAD will undergo a 48 hour computer assisted ambulatory electroencephalogram
Intervention Type
Diagnostic Test
Intervention Name(s)
Computer assisted ambulatory electroencephalogram
Other Intervention Name(s)
CAA-EEG
Intervention Description
A portable 16 channel CAA-EEG is used to detect epileptiform abnormalities in a 48 hour ambulatory electroencephalogram (EEG)
Primary Outcome Measure Information:
Title
Electrographic seizures: Number of subjects with electrographic seizures
Description
Number of subjects with electrographic seizures in 48 hours on computer assisted ambulatory EEG
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria for EOAD patients will be recruited from the LEADS trial with the following:
40 to 64 years of age
Meets NIA-AA criteria for mild cognitive impairment (MCI) due to AD or probable AD dementia.
Have a global CDR score of ≤ 1.0
Have capacity to provide informed consent (ICF) or has a legal authorized representative or guardian who provides IC.
Amyloid positive status (PET scan with evidence of elevated amyloid)
Must have a study partner (informant) who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, and caregiver) who is generally aware of the participants' daily activities and can provide information about the participant's cognitive and functional performance. If the participant does not have a study partner who spends 10 face-to-face hours per week, other arrangements for identifying a viable study partner will be granted on a case-by-case basis by the Site PI.
Not pregnant or lactating. Women must be two years post-menopausal, be surgically sterile, or have a negative pregnancy test prior to each PET scan
Fluent in English.
Exclusion Criteria:
Meets core clinical criteria for non-AD dementia.
Two or more first degree relatives with a history of EOAD suggestive of autosomal dominant transmission, unless known pathogenic mutations in APP, PSEN1, PSEN2 have been excluded.
Known mutation in an ADAD gene (APP, PSEN1, PSEN2) or other autosomal dominant genes associated with other neurodegenerative disorders.
MRI scans with evidence of infection or focal lesions, cortical strokes, multiple lacunes (single lacune is allowable unless it meets criteria for strategic lacune affecting cognition)
Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol (at the discretion of the Site PI)
Medical history of a brain disorder other than the disorder causing dementia except for headache.
Deemed ineligible by the Site PI for any other reason.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina Bunn
Phone
904-953-3930
Email
bunn.sabrina@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neill Graff-Radford, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anton Thomas
Phone
904-953-7103
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease
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