<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FRESH-PEF7969-en" xml-lang="en" xmlns="ddi:codebook:2_5" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="ddi:codebook:2_5 https://ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd">
<docDscr>
  <citation>
    <titlStmt>
      <titl>Longitudinal Study on Multimodal Imaging for Early-Stage Alzheimer's Disease: Biomarkers for Detection and Progression and Physiopathological Mechanisms</titl>
      <IDNo>FRESH-PEF7969-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="GIP CYCERON" role="">Gaël CHETELAT</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Longitudinal Study on Multimodal Imaging for Early-Stage Alzheimer's Disease: Biomarkers for Detection and Progression and Physiopathological Mechanisms            </titl>
      <altTitl>
                    IMAP+                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF7969-en            </IDNo>
      <IDNo agency="PEF">
                    7969                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF7969                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Gaël CHETELAT                                                                                </AuthEnty>
      <AuthEnty affiliation="GIP CYCERON">
        <ExtLink title="SIREN" URI="180089187" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="GIP CYCERON" email="chetelat@cyceron.fr">
                    Gaël;CHETELAT
                                            <ExtLink title="SIREN" URI="180089187" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Genetics</keyword>
      <keyword vocab="" vocabURI="">
                    early diagnosis</keyword>
      <keyword vocab="" vocabURI="">
                    normal ageing</keyword>
      <keyword vocab="" vocabURI="">
                    neuroimaging</keyword>
      <keyword vocab="" vocabURI="">
                    PET</keyword>
      <keyword vocab="" vocabURI="">
                    MRI</keyword>
      <keyword vocab="" vocabURI="">
                    fMRI</keyword>
      <keyword vocab="" vocabURI="">
                    neuroanatomy</keyword>
      <keyword vocab="" vocabURI="">
                    molecular imaging</keyword>
      <keyword vocab="" vocabURI="">
                    FDG-PET</keyword>
      <keyword vocab="" vocabURI="">
                    Alzheimer's disease</keyword>
      <keyword vocab="" vocabURI="">
                    biomarkers</keyword>
      <keyword vocab="" vocabURI="">
                    AV45</keyword>
      <topcClas vocab="health theme">
                        Neurology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D009462"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Psychiatry                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/3de50dee-da1c-4791-a386-56bca24a5fed"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D011570"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Alzheimer disease                                            </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">General objective: To study and compare the effectiveness of different in vivo markers to predict cognitive decline in patients at risk of developing Alzheimer's disease through neuroimaging, neuropsychology and biology measures. Secondary objectives: To study: i) Deterioration in NORMA subjects, as well as SCI, MCI, AD and SAND patients compared with healthy subjects of the same age; ii) Deterioration in E4 allele and apolipoprotein E (ApoE) carriers compared to non-carriers; iii) Cerebral and cognitive changes during normal ageing; iv) Progress and dynamics of different biomarkers during follow-up. To study the links between different deterioration profiles (intra-modality comparison and correlation), as well as differences in inter-group progression profiles.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2012-01-01"/>
      <collDate event="end" date="2019-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">Education level equal to 7 years or higher, native language is French, signed informed consent, medical, neurological and neuroimaging tests, as well as neuropsychological diagnostic test battery.  Control subjects: normal performance according to age and education level in all diagnostic battery tests. Middle-aged (40-59 years old): no memory complaints. Elderly (aged 60+): living at home, independent, no memory complaints.  NORMA (aged 18+) with identified disease, carriers of  mutated gene associated with familial early-onset AD, normal performance according to age and education level in all diagnostic battery tests.  Patients from memory assessment centres:  SCI (aged 50+), no memory complaints, normal performance according to age and education level in all diagnostic battery tests.  MCI meeting current amnestic MCI criteria with memory complaints, objective episodic memory deficits, performances in other cognitive functions where memory loss could occur, standard performance for age and education level in assessments of overall cognitive ability, independent in everyday life, no dementia according to DSM-IV criteria and no probable AD according to NINCDS-ADRDA criteria.  Alzheimer's patients meeting NINCDS-ADRDA criteria for probable AD with abnormal overall cognitive function and deficits in at least 2 cognitive areas identified by diagnostic battery tests; mild- to moderate-stage AD; accompanying party's signed informed consent.   SAND: CHU neurology departments - major episodic memory disorder that may be related to an objective deficit in executive function and standard performance for age and education level in all diagnostic battery tests measuring instrumental function.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>NINCDS-ADRDA and DSM IV</standardName>
        </standard>
      </standardsCompliance>
      <otherQualityStatement>A diagnostic commission is organised on a monthly basis to report subject/patient neuropsychological results</otherQualityStatement>
      <otherQualityStatement>as well as their enrolment category</otherQualityStatement>
      <otherQualityStatement>on a case-by-case basis. A multimodal meeting is organised on a monthly basis to report quality control results for imaging data. This trial is monitored by a person appointed by the CHU to ensure that exact</otherQualityStatement>
      <otherQualityStatement>complete and reliable data is collected and to provide logistical support to research centres.</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.) Population database for statistical purposes</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Recording (audio, video, electrophysiological, imaging)                                                            <concept vocab="CESSDA" vocabURI="Recording"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>280</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
