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| Name | Class |
|---|---|
| Zealand University Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
| University of Aarhus | OTHER |
| T&W Engineering A/S |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| The correlation between cerebral blood flow and paroxysmal acitivity | Compare the amount of paroxysmal activity as measured with ear-EEG and the cerebral blood flow (rCBF) as measured with arterial spin labeling fMRI in patients with Alzheimer's disease and Lewy body dementia | 2 years |
Inclusion Criteria (Alzheimer's disease):
Exclusion Criteria (Alzheimer's disease):
Inclusion Criteria (Lewy body dementia):
Exclusion Criteria (Lewy body dementia):
Inclusion Criteria (Healthy controls):
Exclusion Criteria (Healthy controls):
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gunhild Waldemar | Copenhagen | Copenhagen OE | 2100 | Denmark | ||
| Troels Wesenberg Kjær |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40272733 | Derived | 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. | |
| 38610005 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2020 | May 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D020961 | Lewy Body Disease |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| INDUSTRY |
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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.
| Roskilde |
| 4000 |
| Denmark |
| 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. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |