Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT04628702
Eligibility Criteria:
Inclusion Criteria:
Persons with dementia
* are diagnosed of possible or probable dementia according to NINCDS-ADRDA criteria (McKhann et al. 2011).
* are older than 40 years at baseline examination.
* are able to speak and understand German and possesses sufficient physical, auditory and visual faculties to take part in a neuropsychological examination and a tablet-based training.
* have been receiving stable medication therapy for a minimum of 3 months before the baseline examination.
* who have been treated with a Memantine therapy, which started 3 months before the baseline examination.
* will be accompanied to the neurological examinations at T0a and T3a at the University Clinic of Neurology by an informal caregiver (relative or other significant person).
* may receive professional 24-hours-care - in this case an informal caregiver must be recruited as participant/accompanying person.
* live at home, with or without an informal caregiver (if alone, an informal caregiver should live nearby).
* receive professional care (e.g. home care services) or informal care (e.g. relatives) or no care yet.
* are willing and able to give informed consent or an informal caregiver with power of representation or a trustee gives the informed consent to participation in the study.
* do not receive any antipsychotic or antidepressive medication or have been stably adjusted to the medication for a minimum of 14 days before study start.
Informal caregivers
* are significant persons (e.g. family members, friends) of the participating persons with dementia (adults) which provide or do not provide care.
* living or not living with the person with dementia in the same household.
* are associated with a person with dementia receiving or not receiving professional care.
* speak and understand German.
* are able to give informed consent to participation in the study.
Dementia trainers
* are adults.
* are trained as M.A.S. (Morbus Alzheimer Syndrome) trainer.
* train the participants with dementia at home.
* speak and understand German.
* are able to give informed consent to participation in the study.
Exclusion Criteria
* Participation in a clinical trial until the last three months before study entry
* The participant presumably cannot finish the study
* Any of the following signs in brain MRI:
* Infarct close to major vessels
* More than one lacunar infarction (diameter 1.5cm in every spatial direction)
* One lacunar infarct in a strategic region, such as the thalamus, the hippocampus or the caudate nucleus
* Confluent lesions in deep white matter (Fazekas Score 3)
* Other focal lesions potentially causing cognitive status (e.g. infections, lesions, normal pressure hydrocephalus)
* A general anesthetic three months before study entry or during study period
* The participant has a immunomodulating treatment or will receive a immunomodulating treatment during study period
* Cancer (last treatment \>=5 years before study entry)
* Myocard infarction within 2 years before study entry
* Hepatitis B, C, HIV, Syphilis
* The patient has an active contagious disease
* The patient has a systemic disease potentially causing rapid progression
* Insufficiently treated cardiac insufficiency (NYHA\>3)
* BMI\>40
* Insufficiently treated diabetes
* Renal failure
* Chronic liver disease
* Other clinically relevant systemic diseases
* The Patient suffers from hypothyreosis. Patients with treated hypothyreosis may participate if stable therapy since \>3 months is given
* Psychiatric diseases, such as schizophrenia, psychotic diseases or a bipolar disease
* Current depressive episode or major depression within the last 2 years before study entry
* Metabolic or toxic encephalopathy or dementia due to general medical conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
101 Years
Study:
NCT04628702
Study Brief:
Protocol Section:
NCT04628702