F00 F00 F01 F06.7
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Degree of dementia: CDR memory value 9; subjective cognitive impairment, MCI, mild to moderate Alzheimer's disease or vascular dementia
Exclusion criteria
Exclusion criteria: CDR memory value = 2 or MMSE = 9; severe Alzheimer's disease, frontotemporal dementia, levy body dementia, dementia in Parkinson's disease, other rare forms of dementia (corticobasal degeneration, Korsakoff's disease, Creutzfeldt-Jakob disease, PCA), severe psychiatric illness or previous illness (drug or alcohol abuse / - looking for the last 5 years, acute suicidality), brain tumor, cerebral hemorrhage, stroke, traumatic brain injury, acute inflammatory diseases of the CNS, hydrocephalus, no sufficient german language skills
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurocognition is measured using the CERAD-plus (consortium to establish a registry for Alzheimer`s disease). All CERAD subscales (except the MMSE) are z-standardized and then averaged. Neurocognitive disorder (NCD) is determined by medical scientists/neurologists based on clinical self and informant reports, neuropsychological examinations, imaging methods and standard biochemical analyses according to the NIA-AA criteria for dementia and MCI. MCI and dementia are put together in one group of NCD (MCI, dementia = NCD). The dichotomized NCD classification is used as primary outcome. NPS are measured using the Neuropsychiatric Inventory (NPI) being completed with an informant. The NPI total score (12 symptoms) is calculated by multiplying the frequency and severity of each symptom and calculating a total sum score (max. 144 points). | — |
Secondary
| Measure | Time frame |
|---|---|
| The above described NCD-classification consisting of the Groups healty, SCI, MCI and dementia is used as secondary outcome. Daily-life functioning is assessed by the clinical dementia rating scale (CDR) or the quick dementia rating system (QDRS) by creating a sum of box score (SOB). If there is no CDR SOB score available (no informant), the QDRS SOB score, evaluated by a neuropsychologist, is used. For the classification, the six first domains that are congruent with the CDR are used to calculate the SOB score. As secondary outcome for neuropsychiatric symptoms the short form of the geriatric depression scale (GDS; 15 items) is used. | — |
Countries
Germany
Contacts
Universitätsklinikum Ulm Neurologie