20 Participants Needed

Computer Assisted Ambulatory EEG Monitoring for Early Onset Alzheimer's Disease

SB
Overseen BySabrina Bunn
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.

What data supports the idea that Computer Assisted Ambulatory EEG Monitoring for Early Onset Alzheimer's Disease is an effective treatment?

The available research shows that Computer Assisted Ambulatory EEG Monitoring can provide valuable information about the progression of Alzheimer's disease. For example, one study found that patients with abnormal EEG patterns at the early stage of the disease experienced a more severe decline in cognitive functions compared to those with normal EEG patterns. Another study indicated that EEG markers could help identify Alzheimer's patients who might need more clinical attention due to their 'frailty'. While these studies highlight the usefulness of EEG in predicting disease progression and patient outcomes, they do not directly show that EEG monitoring is an effective treatment for Alzheimer's disease itself. Instead, they suggest that EEG can be a helpful tool in managing and understanding the condition.12345

What safety data exists for Computer Assisted Ambulatory EEG Monitoring?

The provided research does not directly address safety data for Computer Assisted Ambulatory EEG Monitoring. However, it highlights that ambulatory EEG (AEEG) is a well-established technique used for long-term monitoring in various settings, including at home, and is considered a cost-effective alternative to inpatient monitoring. The studies emphasize the importance of technical standards to ensure quality, but specific safety data is not mentioned.678910

Is the treatment in the trial 'Computer Assisted Ambulatory EEG Monitoring for Early Onset Alzheimer's Disease' a promising treatment?

Yes, the treatment is promising because EEG monitoring can help predict the progression of Alzheimer's disease, identify patients who may need more attention, and differentiate between Alzheimer's patients and healthy individuals. This can lead to better management and care for those with the disease.12111213

What is the purpose of this trial?

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.

Research Team

NG

Neill Graff-Radford, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

You are between 40 and 64 years old.
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.
Patients with early-onset Alzheimer's disease from the LEADS trial.
See 11 more

Exclusion Criteria

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.
Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol (at the discretion of the Site PI)
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

EEG Monitoring

Participants undergo a 48-hour computer assisted ambulatory electroencephalogram to determine the frequency of seizures and epilepsy

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after EEG monitoring

4 weeks

Treatment Details

Interventions

  • Computer assisted ambulatory electroencephalogram
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Findings from Research

In a study of 24 Alzheimer patients over 3 years, EEG findings showed that while most patients experienced slowing of brain activity, a subgroup of 12 patients maintained stable EEGs and mild dementia, indicating a potentially benign course of the disease.
EEG slowing at diagnosis was linked to worse outcomes after 3 years, with absolute theta amplitude being the most effective predictor of patient prognosis, highlighting the importance of EEG in assessing the progression of Alzheimer's disease.
Serial EEG in Alzheimer's disease: 3 year follow-up and clinical outcome.Soininen, H., Partanen, J., Laulumaa, V., et al.[2019]
The study identified an EEG marker that can effectively classify Alzheimer's disease (AD) patients with 77.2% sensitivity and 65% specificity, based on a sample of 127 AD individuals and 121 cognitively intact elderly controls.
AD patients with a positive EEG marker (EEG+) exhibited lower cognitive function and more significant brain abnormalities compared to those with a negative marker (EEG-), suggesting that EEG+ patients may require closer clinical monitoring and could be used to create more uniform groups in clinical trials.
Neurophysiological assessment of Alzheimer's disease individuals by a single electroencephalographic marker.Lizio, R., Del Percio, C., Marzano, N., et al.[2016]
In a study of 24 Alzheimer's disease patients over 3 years, those with abnormal EEG (DEEG) experienced significant declines in specific cognitive functions like praxic abilities and naming, while those with normal EEG (NEEG) did not show such deterioration.
Patients with DEEG also had a higher likelihood of developing extrapyramidal symptoms and a greater risk of needing institutional care, suggesting that an abnormal EEG may indicate a more severe progression of cognitive decline in Alzheimer's disease.
Different patterns of cognitive decline related to normal or deteriorating EEG in a 3-year follow-up study of patients with Alzheimer's disease.Helkala, EL., Laulumaa, V., Soininen, H., et al.[2019]

References

Serial EEG in Alzheimer's disease: 3 year follow-up and clinical outcome. [2019]
Neurophysiological assessment of Alzheimer's disease individuals by a single electroencephalographic marker. [2016]
Different patterns of cognitive decline related to normal or deteriorating EEG in a 3-year follow-up study of patients with Alzheimer's disease. [2019]
Quantitative spectral electroencephalography in predicting survival in patients with early Alzheimer disease. [2019]
Rate of cognitive decline in Alzheimer's disease is associated with EEG alpha power. [2019]
Ambulatory EEG: a cost-effective alternative to inpatient video-EEG in adult patients. [2018]
Minimum Technical Requirements for Performing Ambulatory EEG. [2022]
[Ambulatory monitoring of the EEG (A/EEG). Guidelines, methodology and indications]. [2015]
[The role of ambulatory electroencephalogram monitoring: experience and results in 264 records]. [2018]
The clinical utility of ambulatory EEG in childhood. [2019]
[Quantified EEG in the diagnosis of Alzheimer's type dementia]. [2019]
Longitudinal EEG spectral analysis in early stage of Alzheimer's disease. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Identification of resting and active state EEG features of Alzheimer's disease using discrete wavelet transform. [2013]
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