Clinical trial: Epileptic Activity in Patients With Alzheimer's Disease and Lewy Body Dementia (NCT04436341)

Eligibility criteria:
Inclusion Criteria (Alzheimer's disease):

          -  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

          -  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)

        Exclusion Criteria (Alzheimer's disease):

          -  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

        Inclusion Criteria (Lewy body dementia):

          -  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)

        Exclusion Criteria (Lewy body dementia):

          -  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

        Inclusion Criteria (Healthy controls):

          -  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

        Exclusion Criteria (Healthy controls):

          -  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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 90 Years

Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Entailment