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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002583
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Neill R. Graff-Radford, M.D., Mayo Clinic

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

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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 : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002583


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
Additional Information:
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Responsible Party: Neill R. Graff-Radford, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04002583    
Other Study ID Numbers: 19-003078
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders