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出境医 / 临床实验 / 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease

48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease

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.

Condition or disease Intervention/treatment Phase
Early Onset Alzheimer Disease Diagnostic Test: Computer assisted ambulatory electroencephalogram Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Prospective Study Evaluating the Use of 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease
Actual Study Start Date : February 19, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Early-onset Alzheimer's disease (EOAD) subjects
Subjects with mild cognitive impairment due to EOAD will undergo a 48 hour computer assisted ambulatory electroencephalogram
 Diagnostic Test: Computer assisted ambulatory electroencephalogram
A portable 16 channel CAA-EEG is used to detect epileptiform abnormalities in a 48 hour ambulatory electroencephalogram (EEG)
Other Name: CAA-EEG
Outcome Measures
Primary Outcome Measures :
  1. Electrographic seizures: Number of subjects with electrographic seizures [ Time Frame: 48 hours ]
    Number of subjects with electrographic seizures in 48 hours on computer assisted ambulatory EEG


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: Sabrina Bunn 904-953-3930 bunn.sabrina@mayo.edu

Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Anton Thomas    904-953-7103      
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Neill Graff-Radford, MD Mayo Clinic
Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date February 23, 2021
Actual Study Start Date  ICMJE February 19, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019) 		Electrographic seizures: Number of subjects with electrographic seizures [ Time Frame: 48 hours ]
Number of subjects with electrographic seizures in 48 hours on computer assisted ambulatory EEG
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease
Official Title  ICMJE A Prospective Study Evaluating the Use of 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Early Onset Alzheimer Disease
Intervention  ICMJE Diagnostic Test: Computer assisted ambulatory electroencephalogram
A portable 16 channel CAA-EEG is used to detect epileptiform abnormalities in a 48 hour ambulatory electroencephalogram (EEG)
Other Name: CAA-EEG
Study Arms  ICMJE Experimental: Early-onset Alzheimer's disease (EOAD) subjects
Subjects with mild cognitive impairment due to EOAD will undergo a 48 hour computer assisted ambulatory electroencephalogram
Intervention: Diagnostic Test: Computer assisted ambulatory electroencephalogram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sabrina Bunn 904-953-3930 bunn.sabrina@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002583
Other Study ID Numbers  ICMJE 19-003078
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Neill R. Graff-Radford, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neill Graff-Radford, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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