Epileptic Activity in Patients With Alzheimer's Disease and Lewy Body Dementia

NCT04436341 | Completed

• 1 other identifier: H-17035751
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

In the current study, the investigators will examine the extent of subclinical epileptic activity in patients with Alzheimer's disease and patients with Lewy body dementia as compared to healthy elderly controls. The participants will wear a new device called "ear-EEG", which makes it possible to record EEG for longer periods of time while at home. Furthermore, the investigators want to investigate whether there is an association between subclinical epileptic activity and the cerebral blood flow as measured with functional MRI.

Conditions

Alzheimer Disease; Lewy Body Disease; Epilepsy

Outcome Measures

Primary Outcomes (2)

• Feasibility study: Investigate whether patients with Alzheimer's disease are able wear ear-EEG for longer than 24 hours during a 48 hours period

  If it is possible for patients with Alzheimer's disease to wear ear-EEG for at least 24 hours including 5 hours of sleep during a 48 hours period

  8 months

• Epileptic activity in patients with Alzheimer's disease and Lewy body dementia as compared to healthy elderly controls

  Compare the prevalence and type of paroxysmal activity as measured with the ear-EEG in patients with Alzheimer's disease and Lewy body dementia as compared to healthy elderly controls

  2 years

Other Outcomes (1)

• The correlation between cerebral blood flow and paroxysmal acitivity

  2 years

Study Arms (3)

Patients with Alzheimer's disease

No treatment interventions. Investigations: physical examination, ear EEG, cranial MR, cognitive tests, blood samples

Patients with Lewy body dementia

No treatment interventions. Investigations: physical examination, ear EEG, cranial MR, cognitive tests, blood samples

Healthy controls

No treatment interventions. Investigations: physical examination, ear-EEG cranial MR, cognitive tests, blood samples

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the first part of the study (feasibility), the investigators will include 10 patients with Alzheimer's disease from the memory clinics at Rigshospitalet and Zealand University Hospital - Roskilde. In the main study, the investigators will include an additional 40 patients with Alzheimer's disease, 20 patients with Lewy body dementia, and 50 healthy controls.

You may qualify if:

• Meet the criteria for probable Alzheimer's disease with amnestic presentation as described in the NIA-AA criteria (McKhann 2011)
• The diagnosis has been made by either a neurologist, psychiatrist or a geriatrician at the memory clinic at Rigshospitalet or Zealand University Hospital
• The participant is between 50 and 90 years old
• The MMSE score is between 16-28
• The participant does not wear a hearing aid
• The participant is a native Danish speaker
• The participant has at least attended school for 7 years
• The participants' hearing and vision is sufficient to participate in neuropsychological tests
• The participants' general condition of health allows that the participant can cooperate with the trial
• The participant does not suffer from psychiatric diseases (except mild depressive symptoms or mild depression) or neurological diseases that affect the brain other than Alzheimer's disease
• No overuse of alcohol or intake of illegal drugs within the last 2 years
• The participant has previously undergone a CT or MRI scan, which is compatible with Alzheimer's disease
• The participant does not have any contraindications for MRI or MRI contrast
• The participant is living with another person, who is willing to take part in the trial, and who is together with the person long enough to observe the behavior (if any epileptic activity should arise)

You may not qualify if:

• Diagnosis of epilepsy prior to the diagnosis of Alzheimer's disease was made
• Other focal pathology in the hippocampus for example hippocampal sclerosis
• The person living with the participant is not able to participate (e.g. due to a serious disease or disability) in the clinical visits or able to register behavior suspected of epilepsy
• The participant is living in a nursing home
• The participant is treated with antiepileptic medication, tricyclic antidepressants or antipsychotics
• Daily or nearly daily intake of medication known to have an anticholinergic or an adrenergic effect, which is suspected to affect the cognitive abilities or the EEG
• Large brain infarctions or more than 4 lacunar infarcts
• The participants is suffering from uncontrollable movements of the face as for example oral dyskinesia
• Meet the criteria for Lewy body dementia as described in dementia with Lewy body consortium (McKeith 2017)
• The diagnose has been made by either a neurologist, psychiatrist or a geriatrician at the memory clinic at Rigshospitalet or Zealand University Hospital
• The participant is between 50 and 90 years old
• The MMSE score is between 16-28
• The participant does not wear a hearing aid
• The participant is a native Danish speaker
• The participant has at least attended school for 7 years

Sponsors & Collaborators

• Danish Dementia Research Centre: lead
• Zealand University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• University of Aarhus: collaborator
• T&W Engineering A/S: collaborator

Study Sites (2)

Gunhild Waldemar

Copenhagen, Copenhagen OE, 2100, Denmark

Location

Troels Wesenberg Kjær

Roskilde, 4000, Denmark

Location

Related Publications (1)

• Musaeus CS, Kjaer TW, Lindberg U, Vestergaard MB, Bo H, Larsson W, Press DZ, Andersen BB, Hogh P, Kidmose P, Hemmsen MC, Rank ML, Hasselbalch SG, Waldemar G, Frederiksen KS. Subclinical epileptiform discharges in Alzheimer's disease are associated with increased hippocampal blood flow. Alzheimers Res Ther. 2024 Apr 12;16(1):80. doi: 10.1186/s13195-024-01432-9.

  PMID: 38610005 DERIVED

Biospecimen

Retention: NONE RETAINED

A total of 13 mL of blood will be collected from each participant. Afterwards, the blood will be centrifuged and the serum, plasma and the white blood cells will be extracted. These samples will be stored in the Danish Dementia Biobank.

MeSH Terms

Conditions

Alzheimer Disease; Lewy Body Disease; Epilepsy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Study Officials

• Gunhild Waldemar, MD

  Danish Dementia Research Centre

  PRINCIPAL INVESTIGATOR

• Christian S Musaeus, MD

  Danish Dementia Research Centre

  PRINCIPAL INVESTIGATOR

• Troels W Kjær, MD

  Zealand University Hospital - Roskilde

  PRINCIPAL INVESTIGATOR

• Kristian S Frederiksen, MD

  Danish Dementia Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2019
• First Posted: June 18, 2020
• Study Start: September 20, 2019
• Primary Completion: September 1, 2022
• Study Completion: June 1, 2023
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

DK (2)