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Computer Assisted Ambulatory EEG Monitoring for Early Onset Alzheimer's Disease
N/A
Recruiting
Led By Neill Graff-Radford, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
Study Summary
This trial is testing how often seizures and epilepsy occur in patients with Early-onset Alzheimer's disease by using a computer to measure brain activity for 48 hours.
Who is the study for?
This trial is for people aged 40-64 with Early-onset Alzheimer's Disease (EOAD) who have a partner to report on their daily activities. Participants must not be pregnant, should speak English, and show amyloid presence in PET scans. They need to meet criteria for mild cognitive impairment or probable AD dementia with a global CDR score of ≤ 1.0.Check my eligibility
What is being tested?
The study uses a 48-hour computer-assisted ambulatory EEG to check how often seizures and epilepsy occur in EOAD patients. It aims to improve understanding of these events' frequency using non-invasive brain monitoring technology.See study design
What are the potential side effects?
Since the intervention involves wearing an EEG device for monitoring brain activity, side effects may include discomfort from the device, skin irritation where electrodes are placed, and potential sleep disturbances during the test period.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Electrographic seizures: Number of subjects with electrographic seizures
Trial Design
1Treatment groups
Experimental Treatment
Group I: Early-onset Alzheimer's disease (EOAD) subjectsExperimental Treatment1 Intervention
Subjects with mild cognitive impairment due to EOAD will undergo a 48 hour computer assisted ambulatory electroencephalogram
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,766,991 Total Patients Enrolled
Neill Graff-Radford, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are between 40 and 64 years old.You have symptoms that match the main features of non-Alzheimer's dementia.If two or more close family members have early-onset Alzheimer's disease that seems to run in the family, you may not be able to participate unless specific gene mutations have been ruled out.You have a specific gene mutation linked to certain neurodegenerative disorders.Your MRI scan shows signs of infection, specific types of strokes, or multiple small areas of damage in the brain.You have a history of brain disorders, except for headaches.Patients with early-onset Alzheimer's disease from the LEADS trial.You are between 40 and 64 years old.You have been diagnosed with mild cognitive impairment or probable Alzheimer's disease.You have a cognitive impairment that affects your daily functioning.You have a positive amyloid status on a PET scan.You have capacity to provide informed consent (ICF) or has a legal authorized representative or guardian who provides IC.You have been diagnosed with mild cognitive impairment or probable Alzheimer's disease dementia based on specific criteria.You have a global CDR score of 1.0 or lower.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Early-onset Alzheimer's disease (EOAD) subjects
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can you provide a count of the participants for this investigation?
"Right, clinicaltrials.gov indicates that this medical experiment is currently in the process of recruitment. It was first posted on February 19th 2020 and updated most recently on January 3rd 2022; with a target enrollment of 20 patients across 1 center."
Answered by AI
Is there an opportunity for enrollment in this investigation?
"Affirmative. According to information hosted on clinicialtrials.gov, this research study remains open and actively searching for 20 participants across a single site. The trial was initially made available on February 19th 2020 before being modified most recently on January 3rd 2022."
Answered by AI
Who would be qualified to join this research study?
"This trial is searching for around 20 Alzheimer's patients who are between 40 and 64 years old. All interested participants must meet these criteria to be accepted into the study."
Answered by AI
Is geriatric participation allowed in this research?
"This trial is only open to individuals between 40 and 64 years of age. For younger patients, there are 23 available clinical trials while those over 65 have 538 alternatives."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Florida
North Carolina
Other
How old are they?
18 - 65
65+
What site did they apply to?
Mayo Clinic in Florida
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
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