miR-AD: miRNAs for early detection of Alzheimer's disease.

Conditions: F06.7
Mild cognitive disorder

Registration Number: DRKS00027028

Lead Sponsor: Hummingbird Diagnostics GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 243

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

- 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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br>