F00.1 F00.2 F01 F06.7
Conditions
Interventions
Group 1: Hospitalized geriatric patients with suspected neurodegenerative disease will be recruited in several departments of geriatry in Berlin and Potsdam.
If standard neuropsychological testing d
Sponsors
Charité Campus Charité Mitte
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: General inclusion criteria: • written informed consent • hospitalized in a geriatric ward with expected duration of the stay > 2 weeks • mild cognitive impairment or possible AD or possible vascular dementia • 'unclear' case • general condition allows participation in the trial • age = 65 years • good knowledge of the German language • a relative of the patient is available to support the patient in the participation of the trial including neuropsychological testing. Specific inclusion criteria for patients with suspected AD: • possible AD • MMSE: 18-24 Specific inclusion criteria for patients with suspected vascular dementia (VAD): • possible VAD • MMSE: 18-24 Specific inclusion criteria for patients with MCI: • all MCI subtypes will be included (not only amnestic MCI) • Mini Mental State Examination (MMSE) = 22 („sensoric deprivation").
Exclusion criteria
Exclusion criteria: • lack of legal capacity to consent in the participation • arrested by court order • lack of consent in archiving and transfer of pseudonymized data • pregnancy and / or breast feeding • participation in another clinical trial during the last 3 months • participation in another clinical study with radiation exposure and / or lumbar puncture during the last 3 months • low compliance • history of dementing disorder • history of therapy for dementing disorder (cholinesterase-inhibitors, NMDA receptor antagonists) • expected survival < 3 years • indications for other neurodegenerative disorder than AD (frontotemporal dementia, Lewy body dementia...) • strong indication for secondary dementia (delirium, hypothyreosis, vitamine B12 deficiency, infection...) • acute psychiatric disease which interfers with the participation (schizophrenia, manic depression...) • history of brain trauma, if the cognitive impairment suddenly started at the time of the trauma • large stroke, if it is the cause of the cognitive decline with high probability • oral anticoagulation (only in patients participating im lumbur puncture) • indication of impaired CSF flow or inflammatory lesions • indication of inflammation in the brain in CSF analysis • epilepsy • drugs with strong effects on cerebral function, if these drugs are the cause of the cognitive impairment with high probability • MRI-specific exclusion criteria • missing consent to lumbar puncture does NOT lead to exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of positron emission tomography (PET) with the glucose analog F-18-fluorodeoxyglucose (FDG), either alone or combined with other diagnostic modalities, for the prognosis of dementia 3 years after inclusion in patients with cognitive impairment in a geriatric ward (unclear cases). The following other modalities are investigated • anamnesis • clinical data • standard laboratory tests (blood, urine, cerebrospinal fluid) • apoE genotype • specific markers in cerebrospinal fluid (Aß1-40, Aß1-42, tau, phospho-tau) • magnetic resonance imaging MRI (MPRAGE, ASL, FLAIR, T2*, DTI, TOF-MRA, resting state functional MRI, vessel size imaging) • functional MRI with specific tasks All examinations are performed within a maximum of 2 weeks after inclusion. Follow-up data (clinical data, neuropsychological testing after 12, 24 and 36 months) are used for obtaining a clinical diagnosis as gold standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary aim is to compare the FDG-PET for the prognosis of dementia in these patients with the following modalities: (i) MRI-based morphometry of gray matter (ii) MRI-based charaterization of white matter lesion (iii) quantitative characterization of the large scale network of the brain by resting state fMRI, and (iv) testing cerebrospinal fluid (Aß1-40, Aß1-42,tau, phospho-tau) Another secondary aim is to compare these modalities with respect to their power for the differentiation between Alzheimer's disease and vascular dementia. Finally these methods will be compared with respect to their prognostic value for the prediction of the time course of neuropsychological test parameters. Neuropsychologial testing is performed 12, 24 and 36 months after inclusion. | — |
Countries
Germany
Contacts
Public ContactRalph Buchert
Charité - Universitätsmedizin BerlinKlinik für Nuklearmedizin
Outcome results
None listed