Trial document





This trial has been registered retrospectively.
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  DRKS00007966

Trial Description

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Title

DZNE – Longitudinal Cognitive Impairment and Dementia Study

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Trial Acronym

DELCODE

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to collect over a longer period results to memory function, imaging studies of the brain, such as MRI or PET scan, tests of blood and cerebrospinal fluid (CSF) in connection with the possible occurrence of memory disorders.

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Brief Summary in Scientific Language

DELCODE specifically focuses on the preclinical stage of Alzheimer's disease (AD) with the aim to characterize the neuronal networks mechanisms of cognitive adaptation and decompensation. The focus will be on episodic memory and working memory as potential indicators of preclinical AD (Caseli et al., 2011; Parra et al., 2009). Effects on neuronal networks (e.g. topology, connections strength, consistencies) will be analyzed cross-sectionally and longitudinally and will be used as predictors for cognitive decline. DELCODE will also aim at the refined description of earliest cognitive alterations with neuropsychological tasks beyond the standard assessments. These will be also assessed longitudinally. Markers of the disease pathology (i.e. amyloid and neurodegeneration markers) as well as genetic and non-genetic risk factors and indicators of cognitive reserve will serve as independent variables, and their effect on neuronal network alterations in the presence of disease will be assessed.

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Organizational Data

  •   DRKS00007966
  •   2015/05/04
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  •   yes
  •   Approved
  •   171/13, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   G30 -  Alzheimer disease
  •   F00 -  Dementia in Alzheimer disease
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Interventions/Observational Groups

  •   The longitudinal observational study raises over a longer period results to memory function using the following test:
    - 3T MRI of the brain
    - blood and optional cerebrospinal fluid (CSF) collection
    - physical examination incl. collection of medical, medical history and family history
    - neuropsychological assessment

    The criteria serve to define the group category for participants
    - Alzheimer's disease (AD)
    - Mild cognitive impairment (MCI)
    - Subjective cognitive decline (SCD)
    - Siblings of patients with AD dementia and
    - Healthy controls
  •   Mild cognitive impairment (MCI)

    received the same treatments, see arm 1
  •   Subjective cognitive decline (SCD)

    received the same treatments, see arm 1
  •   Siblings of patients with AD dementia

    received the same treatments, see arm 1
  •   Healthy controls

    received the same treatments, see arm 1
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint of the study is cognitive decline. The cognitive ability is tested longitudinally over 5 years by memory tests (ADAS-cog13, MMSE, FCSRT, SDMT, Digit span test, Clock drawing test, MWT-B) during the annual visits.

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Secondary Outcome

The secondary endpoint is the change in other cognitive domains and leading to a decrease in mental performance and even conversion to dementia. The cognitive ability is tested longitudinally over 5 years by memory tests (ADAS-cog13, MMSE, FCSRT, SDMT, Digit span test, Clock drawing test, MWT-B) during the annual visits.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/04/29
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   90   Years
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Additional Inclusion Criteria

General inclusion criteria:
• informed consent, incl. informed consent for lumbar puncture
• presence of an informant, who is willing to provide information on the participant throughout the study
• presence of an informant, who is not participating in the study and willing to provide information on the healthy control throughout the study
• fluent German language abilities
• age >/= 60 years

Inclusion criteria for respective groups of interest:

SCD Subjects:
• score in the normal range (1.5 SD) of any of the CERAD+ tests at initial clinical assessment prior to study participation in the memory clinic
• patient’s report of cognitive (e.g. memory) decline, about which (s)he expresses concerns (time of onset between the last 6 months and 5 years)

Siblings of patients with AD dementia:
• presence of first degree sibling/ siblings with AD dementia, diagnosed in an expert setting (memory clinic)
• score in the normal range of cognitive assessments at the baseline visit according to 2.2.2.4.

MCI Subjects:
• perform 1.5 SD below the normal range in the delayed recall trial of the CERAD-wordlist at initial clinical assessment prior to study participation in the memory clinic
• subjective cognitive decline by the patient can be present or not
• either the subject or an informant or a clinician has to report a decline in cognitive function causing concerns.
• the subjects must not fulfill dementia criteria.

AD Subjects:
• must fulfill the clinical NINDCS/ADRDA criteria of probable AD (McKhann et al., 2011)

Healthy Controls or 3. Person, who provides information on the particitpantl throughout the study:
• must negate subjective cognitive decline with concerns
• must perform in the normal range of cognitive assessments at the baseline visit according to 2.2.2.4.
• must not have a known first degree relative with dementia (parents > 75y of age or older without dementia)

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Exclusion Criteria

• lack of capability to give informed consent
• any condition that clearly interferes with participation in the study
• any condition that interferes with the clinical or neuropsychological study procedures
• sensory impairment that prevents or significantly interferes with neuropsychological testing
• contraindication for both MRI and lumbar puncture
• severe or unstable medical condition
• current major depressive episode
• psychotic disorder, bipolar disorder, substance abuse at present or in the past
• neurodegenerative disorder other than AD
• vascular dementia
• history of stroke with residual symptoms
• clinical significant abnormalities in Vit. B12 or TSH (not applicable for controls and relatives)
• current or past unstable malignant disease with a reduced life expectancy (< 2 years)
• chronic use of psychoactive drugs with sedative or anticholinergic effects
• use of antidementia drugs in SCD, healthy siblings, MCI (Ginkgo is permitted) and in control subjects
• investigational agents for treatment of dementia or cognitive impairment 4 weeks prior to study entry. Participation in a study using investigational medicinal products will lead to exclusion.

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Addresses

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    • Deutsches Zentrum für Neurodegenerative Erkrankungen e. V. (DZNE)
    • Sigmund-Freud-Str. 27
    • 53127  Bonn
    • Germany
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    • Deutsches Zentrum für Neurodegenerative Erkrankungen e. V. (DZNE)
    • Mr.  Professor Dr. med.  Frank  Jessen 
    • Kerpener Strasse 62
    • 50924  Köln
    • Germany
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    • Deutsches Zentrum für Neurodegenerative Erkrankungen e. V. (DZNE)
    • Ms.  Verena  Proß 
    • Sigmund-Freud-Str. 27
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Zentrum für Neurodegenerative Erkrankungen e. V. (DZNE)
    • Sigmund-Freud-Str. 27
    • 53127  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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