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Alzheimer DiseaseAD-LBD-EPINCT04436341

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

An observational study of Alzheimer Disease and Lewy Body Disease, run by Danish Dementia Research Centre at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease, Lewy Body Disease, Epilepsy
How many people
50 participants
Where
2 sitesDenmark
Study dates
20 Sep 2019to 1 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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
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  • 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
  • The treatment with anti-dementia medication or SSRI drugs have been given in stable dose for at least 3 months up to the inclusion and the doctor including the participant estimates that treatment will not change within the next 6 months
  • 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)
  • 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
  • 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 Lewy body dementia
  • The treatment with anti-dementia medication or SSRI drugs have been given in stable dose for at least 3 months up to the inclusion and the doctor including the participant estimates that treatment will not change within the next 6 months
  • No overuse of alcohol or intake of illegal drugs within the last 2 years
  • 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)
  • Normal cognition as evaluated at the clinical examination
  • 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
  • The participant does not have any contraindications for MRI or MRI contrast

Who cannot join

  • 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
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  • Large brain infarctions or more than 4 lacunar infarcts
  • The participants is suffering from uncontrollable movements of the face as for example oral dyskinesia
  • Diagnosis of epilepsy prior to the diagnosis of Lewy body dementia 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
  • The participants is suffering from uncontrollable movements of the face as for example oral dyskinesia
  • The participant is suffering from epilepsy or receives anti-epileptic medication

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Gunhild Waldemar

    Copenhagen, Copenhagen OE, 2100

  • Troels Wesenberg Kjær

    Roskilde, 4000

Other trials in Denmark

About this study

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.

Medical subject headings
Alzheimer Disease, Lewy Body Disease, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04436341
Study groupRoleWhat they receive
Patients with Alzheimer's diseaseNo treatment interventions. Investigations: physical examination, ear EEG, cranial MR, cognitive tests, blood samples
Patients with Lewy body dementiaNo treatment interventions. Investigations: physical examination, ear EEG, cranial MR, cognitive tests, blood samples
Healthy controlsNo treatment interventions. Investigations: physical examination, ear-EEG cranial MR, cognitive tests, blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 8 months

  2. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2020
  2. Study start20 Sep 2019
  3. Primary completion1 Sep 2022
  4. Study completion1 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04436341
Sponsor's protocol ID
H-17035751
Acronym
AD-LBD-EPI
Status last verified
Mar 2025
First submitted
28 Sep 2019
Last updated
24 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Musaeus CS, Waldemar G, Kjaer TW, Andersen BB, Hogh P, Hasselbalch SG, Lindberg U, Frederiksen KS, Larsson HBW, Vestergaard MB. Normal cerebral oxygen consumption and lactate levels in patients with Alzheimer's disease and Lewy body dementia. Geroscience. 2026 Feb;48(1):421-434. doi: 10.1007/s11357-025-01658-x. Epub 2025 Apr 24.

    PubMed 40272733

  • 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.

    PubMed 38610005

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer Disease and Lewy Body Disease, run by Danish Dementia Research Centre at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility study: Investigate whether patients with Alzheimer's disease are able wear ear-EEG for longer than 24 hours during a 48 hours period (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04436341, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.

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