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Multi-modal Neuroimaging in Alzheimer's Disease (IMAP)

5. marts 2013 opdateret af: University Hospital, Caen

Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging

According to estimations, Alzheimer's disease affects approximately 860,000 people aged of more than 65 years in France. This disease is characterized by disorders of cognitive functions, including memory, associated with structural and functional modifications of the brain. These changes are evolving within the pathology progression and can be evaluated with neuropsychological tests (to assess capabilities such as language, orientation, etc.) and also with brain imaging (e.g. MRI). Alzheimer's disease is still poorly understood, nevertheless currently available treatments can slow its development if the disease is diagnosed early enough.

Thus, the objective is to identify markers for early diagnosis of Alzheimer's disease, to better describe the evolution of this disease.

The three main objectives of this project are

  • to identify, compare and combine predictive markers of Alzheimer's disease
  • to make a significant contribution to the understanding of the pathophysiological mechanisms of Alzheimer's disease
  • to study the ability of different neuroimaging techniques to follow the evolution of this pathology.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

295

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Caen, Frankrig, 14033
        • University Hospital Côte de Nacre
      • Lille, Frankrig, 59037
        • University Hospital Roger Salengro
      • Rennes, Frankrig, 35033
        • University Hospital Pontchaillou
      • Rouen, Frankrig, 76031
        • University Hospital Rouen
      • Tours, Frankrig, 37044
        • university hospital Tours

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Education level > 7 years
  • Native language: French
  • Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:

    • Healthy young controls: between 18 and 40 years old; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
    • Healthy Middle-aged controls: between 40 and 60 years old; without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
    • Healthy Elderly controls: over 60 years old, living at home, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
    • MCI patients: over 60 years old, presenting the current criteria for amnestic MCI including: i) memory complaint, ii) deficits of the episodic memory (lower performance of at least 1.5 SD from the norm for age and cultural level for one or more scores of episodic memory and iii) normal performances compared to the age and the educational level of all other cognitive functions as memory, including tests to assess cognitive abilities.
    • Alzheimer's patients: presenting the standard criteria of NINCDS-ADRDA probable Alzheimer's disease, including abnormal global cognitive function and deficits in at least two cognitive domains identified by the diagnostic battery and a mild to moderate Alzheimer's disease (MMSE ≥ 15).

Exclusion Criteria:

  • The sudden onset of cognitive impairments (as opposed to their slow and gradual installation in Alzheimer's disease)
  • A chronic neurological, psychiatric, endocrine, hepatic or infectious complaint
  • A history of major disease (an uncontrolled diabetes, a lung, heart, metabolic, hematologic, endocrine disease or a severe cancer);
  • A medication that may interfere with memory or metabolic measures
  • A alcohol or drugs abuse
  • claustrophobia, metallic object in the body
  • A predominantly left-hand (score below 50% in Edinburgh Inventory).
  • Protected adults, and persons not affiliated with a social security system will not participate in this study.
  • The inclusion of a participant in another biomedical research protocol (during the study or within 12 months before inclusion)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Young controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Eksperimentel: Middle age controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Eksperimentel: Elderly controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Eksperimentel: Autosomal dominant forms of early-onset Alzheimer disease
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Eksperimentel: Subjectif Cognitive Impariment patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Eksperimentel: Mild Cognitive Impairment patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Eksperimentel: Alzheimer Disease patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Eksperimentel: Non degenerative amnsesic syndrome
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Eksperimentel: Frontotemporal lobe dementia
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Hastighed for volumenændring af hele hjernen, hippocampus og andre strukturelle MR-målinger
Tidsramme: 3 år
3 år
Faldhastighed målt ved: Kognitive tests, Dagliglivsaktiviteter og CDR Sum of Boxes
Tidsramme: 3 år
3 år
Ændringshastigheder på hver specificeret biokemisk biomarkør
Tidsramme: 3 år
3 år
Ændring af glukosemetabolisme (FDG-PET)
Tidsramme: 3 år
3 år
Omfanget af amyloidaflejring målt ved 18F-AV45
Tidsramme: 3 år
3 år
Gruppeforskelle for hver billeddannelse og biomarkørmåling
Tidsramme: 3 år
3 år
APOE genotype
Tidsramme: 3 år
3 år

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2008

Primær færdiggørelse (Forventet)

1. december 2021

Datoer for studieregistrering

Først indsendt

13. marts 2012

Først indsendt, der opfyldte QC-kriterier

13. marts 2012

Først opslået (Skøn)

14. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. marts 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. marts 2013

Sidst verificeret

1. marts 2013

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med assessment of memory

Abonner