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Expansion of tau-pathology along functional Networks of the brain in Alzheimer's disease. A longitudinal multimodal Imaging study

Recruiting
Conditions
G30.0
Alzheimer disease with early onset
Registration Number
DRKS00012289
Lead Sponsor
niversitätsklinikum Köln Klinik und Poliklinik für Nuklearmedizin
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
200
Inclusion Criteria

Principal inclusion criteria
HC Group
1. Age > 50 years
2. Subjectively unimpaired cognitive performance
3. Cognitive testing within age norm
4. Unimpaired in activities of daily living
5. Clinical Dementia Rating (CDR): 0
SCD Group
1. Age > 50 years
2. Subjective decline in cognitive performance as reported by the subject
3. Cognitive testing within age norm
4. Unimpaired in activities of daily living
5. Clinical Dementia Rating (CDR): 0
MCI Group
1. Age > 50 years
2. Fulfils criteria of amnestic type of MCI: 1,5 standard deviations below age norm in VLMT.
3. Unimpaired in activities of daily living (Bayer ADL = 5)
4. Clinical Dementia Rating (CDR) of 0.5
DAT Group
1 Age > 50 years
2 Dementia according to ICD-10-criteria with impairment in activities of daily living.
3 Diagnosis of probable dementia of the Alzheimer type according to NINCDS-ADRDA- criteria
4 Clinical Dementia Rating (CDR) of =2

Exclusion Criteria

Exclusion
HC Group
1. Any radiation exposure in the recent 10 years for scientific or therapy purposes
SCD Group
1. Any radiation exposure in the recent 10 years for scientific or therapy purposes
MCI Group
1. Fulfils criteria for a dementia (ICD-10-criteria).
2. Other disorders potentially responsible for cognitive decline (e.g. cerebrovascular disorder, Parkinson’s disease)
DAT Group
1. Fulfils criteria for other forms of dementia than of the Alzheimer’s type
2. Other disorders potentially responsible for cognitive decline (e.g. cerebrovascular disorder, Parkinson’s disease)

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary trial objective:<br><br>1. To document the presence/location of tau-pathology cross-sectionally and longitudinally in early stages of Alzheimer’s disease<br><br>2. To evaluate if tau-pathology expands along specific functional networks of the brain over time<br><br>3. To investigate if expansion of tau-pathology leads to progressive dysfunction of affected functional brain networks.<br><br>4. To explore the association between cerebral tau-pathology and cognitive decline. <br><br>5. To explore how amyloid-pathology and tau-pathology are associated with each other<br><br><br>Study end points:Primary end points:<br>•Extent of tau-pathology in the brain cross-sectionally and change of it longitudinally<br><br>
Secondary Outcome Measures
NameTimeMethod
Secondary end points<br>•Extent of amyloid-pathology in the brain cross-sectionally and change of it longitudinally<br>•Functional connectivity (brain network function)<br>•Structural connectivity (brain network integrity)<br>•Interaction between tau- and amyloid-pathology and network function and integrity<br>•Cognitive decline <br>•Neuronal activitation (fMRI activation study)
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