Trial document




drksid header

  DRKS00012289

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

TAUNETAD

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The main objective of the current project is to test the network-degeneration hypothesis in AD using multimodal imaging with a specific focus on tau pathology. We are planning to monitor longitudinal expansion of tau-aggregation pathology and put it into context to distribution of amyloid-deposition and to functional network anatomy and integrity. It is well accepted that the aggregation of tau-pathology starts years ahead of the clinical stage of symptomatic dementia. Thus, we will include subjects in early stages of disease and subjects at risk for AD but without manifest dementia

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012289
  •   2017/05/29
  •   [---]*
  •   yes
  •   Approved
  •   15-194, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   G30.0 -  Alzheimer disease with early onset
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Subjective and objective healthy subjects with inconspicuous neuropsychological testing

    Baseline and followup after 12 months: neuropsychological examination,
    PET / CT,
    MRI
  •   Subjects with subjective cognitive impairment, non-objective (subjective cognitive decline (SCI)

    Baseline and followup after 12 months:
    Neuropsychological examination,
    PET / CT,
    MRI
  •   Subjects with objective cognitive impairment, not sufficient for the diagnosis of dementia (mild cognitive impairment, MCI)

    Baseline and followup after 12 months:
    Neuropsychological examination,
    PET / CT,
    MRI
  •   Subjects with manifest Alzheimer's disease in the early stage

    Baseline and followup after 12 months:
    Neuropsychological examination,
    PET / CT,
    MRI
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary trial objective:

1. To document the presence/location of tau-pathology cross-sectionally and longitudinally in early stages of Alzheimer’s disease

2. To evaluate if tau-pathology expands along specific functional networks of the brain over time

3. To investigate if expansion of tau-pathology leads to progressive dysfunction of affected functional brain networks.

4. To explore the association between cerebral tau-pathology and cognitive decline.

5. To explore how amyloid-pathology and tau-pathology are associated with each other


Study end points: Primary end points:
•Extent of tau-pathology in the brain cross-sectionally and change of it longitudinally

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Secondary end points
•Extent of amyloid-pathology in the brain cross-sectionally and change of it longitudinally
•Functional connectivity (brain network function)
•Structural connectivity (brain network integrity)
•Interaction between tau- and amyloid-pathology and network function and integrity
•Cognitive decline
•Neuronal activitation (fMRI activation study)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2019/04/01
  •   200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Köln Klinik und Poliklinik für Nuklearmedizin
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik und Poliklinik für Nuklearmedizin
    • Mr.  Dr.  Jochen  Hammes 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik und Poliklinik für Nuklearmedizin
    • Ms.  Simone  Stockter 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.