Trial document




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  DRKS00011375

Trial Description

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Title

Evaluation study on dementia Berlin-Brandenburg (VDBB)

Epidemiological investigation on the impact of diagnosis, based on biomarker criteria, onto the treatment strategy on patients with cognitive impairment, in the sense of knowledge generating medicine.

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Trial Acronym

VDBB-02

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URL of the Trial

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Brief Summary in Lay Language

In the outpatient clinical setting a definitive diagnosis on Alzheimer's can rarely be made. A false-positive diagnosis though can lead to an inefficient, and an unecessary exhausting treatment for patients as well as unnecessarily onerous costs for the health care system. With a false-positive diagnosis an effective treatment option might be withhold from the patient, and avoidable costs may arise.

An early detection of patients, with whom a diagnosis of suspected Alzheimers disease can be confirmed or ruled out with a high probability, could delay the onset of disorders relevant to everyday life through appropriate early treatment or enhance the quality of life through excluding stressful uncertainty as well as preventing currently inadequate treatment measures.

Within the S3 guideline the diagnosis, additionally based on biomarker criteria, is recommended.
Study participants are patients with mild cognitive impairments, who, after clinical diagnosis, are very likely to be diagnosed with Alzheimer's. The Study will examine, how often the clinical diagnosis differs from the biomarker based diagnosis, as well as the influence of an early and reliable diagnosis on therapy management, course of disease and medical expenses.
The following hypotheses are given:

1. Increase of the reliabilty on the determination of underlying causes of cognitive impairments based on the application of biomarker criteria on the diagnosis
2. Early detection of underlying causes of cognitive impairments
3. Improvement of differential diagnosis on the various forms of dementia
4. Specifically focused and indication-related therapy management due to early and reliable diagnosis

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Brief Summary in Scientific Language

Influence of early and reliable diagnosis through the recommended diagnostic measures of the S3 guidelines based on clinical criteria and biomarker criteria on the patient and the attending physician, regarding the patient management (treatment plan) and other patient-relevant treatment results of cognitive impairment of unknown etiology.

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Organizational Data

  •   DRKS00011375
  •   2017/05/30
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  •   yes
  •   Approved
  •   Eth-09/17, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

  •   U1111-1190-0118 
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Health Condition or Problem studied

  •   F06.7 -  Mild cognitive disorder
  •   F00 -  Dementia in Alzheimer disease
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Interventions/Observational Groups

  •   The participating patients will be examined within the standard care setting of the S3-guideline for dementia. The diagnostics will be conducted in accordance with clinical criteria (neuropsychological testing, lab results, MRI or CT). In case this procedure leads to a probable Alzheimer's diagnosis, diagnostics will be carried out according to the biomarker criteria (amyloid PET). Also to be investigated is, how often PET diagnostics differ from the suspected diagnosis. Using neuropsychological testing and recording health costs, data will be collected over an observation period of 2 years, examining the influence of early diagnosis on therapy treatment, course of disease and medical expenses.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Percentage of patients, whose diagnosis based on biomarker criteria differs from those, based on clinical diagnosis.

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Secondary Outcome

a. Percentage of patients, whose theraply plan changed based on the biomarker criteria diagnosis
b. Modification of cognitive impairments within the patient group
c. Modification of the patient's quality of life
d. Modification of psychological and behavioural symptoms
e. Modification of resource utilization/costs

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/06/29
  •   41
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   75   Years
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Additional Inclusion Criteria

1. Adults age ≤ 75
2.Patients with mild cognitive impairment (MCI) or mild dementia (MMST ≥ 20 points or DemTect ≥ 9 points) with suspicion of Alzheimer's (Hachinski test < 4 points)
3.According to guidelines with biomarkers continuative diagnostics is recommended by the examining physician.
4.The patient is voluntarily taking part in the study and has given his written permission for the use of his pseudonymized patient data.

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Exclusion Criteria

1. Previous amyloid PET scan with available investigating results.
2. Simultaneous participating in a clinical trial on disease-modifying treatments for Alzheimer's
3.Severe depression (GDS > 10 points)
4.The occurrence of a neurological disorder, frequently associated with dementia, e.g. Parkinson's disease
5.Significant discrepancies in the results of physical examination, vital functions and laboratory examination, which require further examination or treatment
6.Dependency disorders (e.g. benzodiazepine, alcohol)
7.Intake of cognitive impairing medication
8.Serious illness, that could prevent a participation throughout the entire observation period
9. Lives at a nursing home.
10. Pregnancy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • DTZ Berlin
    • Mr.  Prof. Dr. med.  Wolfgang  Mohnike 
    • Kadiner Str. 23
    • 10243  Berlin
    • Germany
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    • DTZ Berlin
    • Mr.  Prof. Dr. med.  Wolfgang  Mohnike 
    • Kadiner Str. 23
    • 10243  Berlin
    • Germany
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    • alesco.concepts
    • Ms.  M.A.  Sabine  Thürk 
    • Christinenstr. 18/19
    • 10119  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Piramal Imaging Ltd.
    • Langstone Road, Havant
    • PO9 1SA  Hampshire
    • United Kingdom
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    • Siemens Healthcare GmbH
    • Karlheinz-Kaske-Str. 2
    • 91052  Erlangen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.