Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Co-LEsions in Alzheimer Disease and Related Disorders (CLEM)

22 augusti 2017 uppdaterad av: Hospices Civils de Lyon

One of the crucial challenges for the future of Alzheimer's disease (AD) therapeutic approaches in elderly is to target the main pathological process responsible for disability and dependency. However, a progressive cognitive impairment occurring after the age of 70 is often related to mixed lesions of neurodegenerative and vascular origins. Whereas young patients are mostly affected by pure lesions, aging favors the occurrence of co-lesions of AD, vascular and Lewy body types. Pure DLB (Dementia with Lewy Body) and AD are distinct disorders but they often coexist in old age patients, the Abeta pathology of DLB/AD cases being different to that observed in patients with AD alone. Vascular dementia (VD) and AD with cerebrovascular disease (AD+CVD) are the leading causes of dementia next to AD alone. Lack of consensus persists about the diagnosis criteria for VD and AD+CVD, due in part to their clinical, pathological heterogeneity and the multiple pathological subtypes.

We do not know the precise role and weight of each brain lesion type in the disability progression in elderly. To target the actual pathological process, we need to disclose the functional weight of AD, Lewy body and vascular lesion types in elderly. Most of the studies report on functional and clinical abnormalities in patients with pure pathologies. Thus, co-morbid processes involved in the transition from an independent functional status to disability in the elderly with co-lesions still remain to be elucidated. Neuropathological examination often performed at late stages cannot answer this question at mild or moderate stages.

Brain MRI, Single Photon Emission Computed Tomography (SPECT) with DaTscan® and CSF biomarkers help routinely in performing the diagnosis of pure or mixed lesions responsible for dementia. The topography of the atrophy in MRI helps to provide information about the etiological diagnosis. Medial temporal lobe atrophy on MRI has good discriminatory power for AD compared to DLB and VD in pathologically confirmed cases. DaTscan® SPECT presents with good sensitivity and specificity at early stages of DLB. The good diagnosis value of CSF biological markers has led recently to their inclusion in the research diagnosis criteria of AD. Low Aβ1-42 and high levels of total tau and hyperphosphorylated tau isoforms appear to be the most sensitive and specific CSF biomarkers. Aβ1-42 is lowered in AD, as well as in other neurodegenerative diseases like DLB, VD. The combination of MRI, particularly medial temporal atrophy measures and vascular lesions on FLAIR MRI sequences, SPECT and CSF biomarkers seem to be of incremental value for the diagnosis AD, VD, DLB and mixed profiles.

The aim of this study is to identify the biomarkers (MRI, SPECT-DaTscan® and CSF), and their combination, that are the most predictive of functional disability in elderly presenting with a progressive cognitive decline related to AD, DLB, VD and all mixed patterns.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Förväntat)

214

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Villeurbanne, Frankrike, 69100
        • Rekrytering
        • Hopital Charpennes
        • Kontakt:
        • Huvudutredare:
          • Pierre KROLAK-SALMON

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

70 år och äldre (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Male or female subject aged over 70 years
  • Out-patient consulting at one of the Memory Centres participating to the study
  • Patients meeting diagnosis criteria for dementia due to Alzheimer's disease (McKhann, Knopman et al. 2011), vascular dementia (NINCDS-AIREN criteria, Roma´n, G. C., Tatemichi, T. K., Erkinjuntti, T., et al. (1993), Lewy body disease (McKeith, Dickson et al. 2005), and patients presenting with mixed signs and symptoms suggesting a combination of these diagnosis
  • Mild or moderate dementia stage (MMSE criteria > 15)
  • Being affiliated to health insurance
  • Patient with sufficient visual, auditory and oral and written French language skills to complete the clinical and neuropsychological evaluations
  • Accompanied by a close relation in sufficient contact with the subject to assess their dependency

Exclusion Criteria:

  • Patients with psychiatric disorders (Axe 1 DSMIV (Diagnostic and Statistical Manual of Mental Disorders) disease) excepted patients with depressive or anxious disorders stabilized for more than 3 months
  • Patients taking any neuroleptic psychotropic medication
  • Patients taking other psychotropic medication, with the exception of any antidepressant, hypnotic, anxiolytic, acetylcholinesterase inhibitors or memantine which has been prescribed and stabilised for more than 3 months
  • Patients with signs and symptoms suggestive of dementia related to other diseases than AD, vascular and Lewy diseases, or mixed forms
  • Patients with other neurological diseases
  • Patients with progressive and unstable pathologies which could interfere with the variables under consideration
  • Deafness or blindness which could compromise evaluation of the patient
  • Patients being not able to undergo DaTscan®: with moderate or severe hepatic or renal impairment, a known hypersensitivity to ioflupane or any of the excipients
  • Patient living in an institution
  • Patient meeting brain MRI exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body) or refusing MRI
  • Patient being under guardianship

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Undersökning
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: SPEC-DaTscan
  • Measurement of fixation of DaTscan® in the caudate and lenticular nucleus
  • LP (Lumbar Puncture): the LP will follow the last guidelines published in 2011 (Armand Perret-Liaudet is co-author of these guidelines; Perret-Liaudet A. et al, Cerebrospinal Fluid Collection Tubes: a critical issue for Alzheimer Disease diagnosis. Clin Chem, 2012, accepted).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Disability progression
Tidsram: 2 years
defined by the Disability Assessment in Dementia (DAD) scale (Gauthier, Gelinas et al. 1997; Gelinas, Gauthier et al. 1999)
2 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Neuropsychological inventory
Tidsram: 2 years
For the diagnosis and initial correlation with imaging and CSF markers, o For longitudinal assessments : MMSE (Folstein, Folstein et al. 1975), Batterie Rapide d'Efficience Frontale (BREF) (Dubois, Slachevsky et al. 2000) Adas-Cog (Rosen, Mohs et al. 1984)
2 years
NeuroPsychiatric inventory
Tidsram: 2 years
Inventory described in Cummings, Mega et al. 1994
2 years
Clinical/serum markers
Tidsram: 2 years
Disability progression and cognitive decline
2 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2014

Primärt slutförande (Förväntat)

1 juli 2018

Avslutad studie (Förväntat)

1 oktober 2020

Studieregistreringsdatum

Först inskickad

16 januari 2014

Först inskickad som uppfyllde QC-kriterierna

31 januari 2014

Första postat (Uppskatta)

3 februari 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 augusti 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 augusti 2017

Senast verifierad

1 augusti 2017

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera