F06.7
Conditions
Interventions
Group 1: Patients already diagnosed with "molecular trait Alzheimer's" will be re-contacted at the respective sites to collect blood samples (PAXgene blood, EDTA, serum). In this case, psychometric sc
Sponsors
Hummingbird Diagnostics GmbH
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: Group 1) 120 patients with SCI, MCI or mild dementia (MMSE >20) with confirmed molecular trait Alzheimer's disease (MCI-AD). Group 2) 120 patients with SCI, MCI or mild dementia (MMSE >20) with exclusion of molecular trait Alzheimer (MCI-other). Additional inclusion criteria are: - Neuropsychiatric examination (CERAD, CDR) at time of blood draw confirming SCI, MCI or Mild Dementia (e.g., MMSE > 20).
Exclusion criteria
Exclusion criteria: - not able to provide consent - advanced dementia MMSE < 20 - cerebral microangiopathy Fazekas grade III - cerebral hemorrhage or cerebral ischemia less than 3 months ago - known infectious diseases (HIV, HCV, HBV) - known cancer in the last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of this study is to assess the diagnostic potential of miRNAs, in particular to what extent miRNAs allow separation of the two study groups, MCI-AD and MCI-other. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective is to study to what extent miRNAs can reflect the apparent clinicopathological heterogeneity within the AD collective, in particular whether distinct subgroups exist that can be classified on the basis of different profiles. Furthermore, a longitudinal analysis of the clinicopathological courses will be performed using the follow-up samples (FUP) obtained 12 months after baseline. | — |
Countries
Germany
Outcome results
None listed