G30 F00
Conditions
Interventions
Group 1: The longitudinal observational study raises over a longer period results to memory function using the following test:
- 3T MRI of the brain
- blood and optional cerebrospinal fluid (CSF) coll
Sponsors
Deutsches Zentrum für Neurodegenerative Erkrankungen e. V. (DZNE)
Eligibility
Sex/Gender
All
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: General inclusion criteria: • informed consent, incl. informed consent for lumbar puncture • presence of an informant, who is willing to provide information on the participant throughout the study • presence of an informant, who is not participating in the study and willing to provide information on the healthy control throughout the study • fluent German language abilities • age >/= 60 years Inclusion criteria for respective groups of interest: SCD Subjects: • score in the normal range (1.5 SD) of any of the CERAD+ tests at initial clinical assessment prior to study participation in the memory clinic • patient’s report of cognitive (e.g. memory) decline, about which (s)he expresses concerns (time of onset between the last 6 months and 5 years) Siblings of patients with AD dementia: • presence of first degree sibling/ siblings with AD dementia, diagnosed in an expert setting (memory clinic) • score in the normal range of cognitive assessments at the baseline visit according to 2.2.2.4. MCI Subjects: • perform 1.5 SD below the normal range in the delayed recall trial of the CERAD-wordlist at initial clinical assessment prior to study participation in the memory clinic • subjective cognitive decline by the patient can be present or not • either the subject or an informant or a clinician has to report a decline in cognitive function causing concerns. • the subjects must not fulfill dementia criteria. AD Subjects: • must fulfill the clinical NINDCS/ADRDA criteria of probable AD (McKhann et al., 2011) Healthy Controls or 3. Person, who provides information on the particitpantl throughout the study: • must negate subjective cognitive decline with concerns • must perform in the normal range of cognitive assessments at the baseline visit according to 2.2.2.4. • must not have a known first degree relative with dementia (parents > 75y of age or older without dementia)
Exclusion criteria
Exclusion criteria: • lack of capability to give informed consent • any condition that clearly interferes with participation in the study • any condition that interferes with the clinical or neuropsychological study procedures • sensory impairment that prevents or significantly interferes with neuropsychological testing • contraindication for both MRI and lumbar puncture • severe or unstable medical condition • current major depressive episode • psychotic disorder, bipolar disorder, substance abuse at present or in the past • neurodegenerative disorder other than AD • vascular dementia • history of stroke with residual symptoms • clinical significant abnormalities in Vit. B12 or TSH (not applicable for controls and relatives) • current or past unstable malignant disease with a reduced life expectancy (< 2 years) • chronic use of psychoactive drugs with sedative or anticholinergic effects • use of antidementia drugs in SCD, healthy siblings, MCI (Ginkgo is permitted) and in control subjects • investigational agents for treatment of dementia or cognitive impairment 4 weeks prior to study entry. Participation in a study using investigational medicinal products will lead to exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is cognitive decline. The cognitive ability is tested longitudinally over 5 years by memory tests (ADAS-cog13, MMSE, FCSRT, SDMT, Digit span test, Clock drawing test, MWT-B) during the annual visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is the change in other cognitive domains and leading to a decrease in mental performance and even conversion to dementia. The cognitive ability is tested longitudinally over 5 years by memory tests (ADAS-cog13, MMSE, FCSRT, SDMT, Digit span test, Clock drawing test, MWT-B) during the annual visits. | — |
Countries
Germany
Contacts
Public ContactProjektmanagment
Deutsches Zentrum für Neurodegenerative Erkrankungen e. V. (DZNE)
Outcome results
None listed