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Trial record 9 of 31 for:    alzheimer dijon

MEMENTO-VAScular COmponents of Dementia (VASCOD)

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ClinicalTrials.gov Identifier: NCT02264899
Recruitment Status : Recruiting
First Posted : October 15, 2014
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
Ministry for Health and Solidarity, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
A Multicenter national longitudinal cohort study including at least 800 individuals recruited from French Research Memory Centers and followed up over 36 months and included in Memento.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease (AD) Alzheimer's Disease (AD) Related Disorders Other: in Memento-VASCOD Not Applicable

Detailed Description:

Alzheimer's disease (AD) is a neurodegenerative disorder thought to be caused by the accumulation of the peptide amyloid beta and the hyperphosphorylated tau protein in the brain. There are increasing arguments in favor of an important role of vascular damages in the development and progression of AD.

The time course of these vascular alterations and how they relate to dementia and AD pathology remain unclear, as no protocol that allows the development of the diverse vascular pathology to be scored, and hence to be tracked with ageing, has so far been developed and widely validated. The aims of this project are to investigate, in a large clinical sample of patients presenting either isolated cognitive complaints or light to mild cognitive deficits, how vascular risk factors and vascular alterations (assessed at macro and micro levels) relate to cerebrovascular disease and cognitive decline.

The primary objective of this ancillary study is to investigate the prospective association between vascular risk factors, inflammation markers and vascular damages on cognitive decline and neurodegeneration progression over up to 4 years of follow-up in a sample of individuals presenting with a spectrum of cognitive profiles ranging from isolated cognitive complaints to cognitive deficits without dementia.

The secondary objectives are the following

  • To investigate the role of vascular risk factors (diabetes, hypertension, hypercholesterolemia) and vascular damages on progression to clinical dementia over up to 4-year follow-up.
  • To study whether the interaction between changes in markers of macrovascular and microvascular structures on cognitive deficits progression.
  • To study the association between in BP, hypertension, antihypertensive treatments and vascular damages, progression of cerebrovascular disease seen at MRI and cognitive decline and dementia risk
  • To assess the temporality of vascular damages burden on neurodegeneration
  • To assess the association between retinal vasculature defect and brain neurovascular damages
  • To study the link between vascular damages and AD pathology (Cerebro-Spinal Fluid (CSF) and Positron emission tomography (TEP) amyloid imaging) biomarkers in the subsample of participants having all measures available
  • To investigate how inflammatory markers mediate the association between vascular damages and neurodegeneration
  • To assess whether vascular factors and neurodegenerative factors act independently or synergistically on the course of cognitive decline
  • To assess simultaneously the impact of vascular damages on end organs (brain, eye, and kidney)
  • To study the correlation between cerebral blood flow, measured by Arterial spin-Labeled (ASL) MRI and cognitive decline
  • To study whether genetic polymorphisms revealed from genome-wide association studies (GWAS) of AD of vascular factors could modulate the association between vascular damages and cognitive decline

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: MEMENTO-VAScular COmponents of Dementia
Actual Study Start Date : November 4, 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Alzheimer's disease and related disorders Other: in Memento-VASCOD
  • Pulse wave velocity assessment
  • Cerebral MRI including Arterial Spin Labeling (ASL) and Magnetic Resonance Angiography (MRA) sequences
  • Ophthalmological exams: Spectral Domain-Optical Coherence Tomography (SD-OCT), colour photographs of the retina, visual acuity and axial lenght measurement
  • Neuropsychological testing and behaviorial and mood scales
  • Urinary albumin excretion measurement



Primary Outcome Measures :
  1. Change in cognitive performances over [ Time Frame: 36 months from baseline ]

Secondary Outcome Measures :
  1. Progression to clinical dementia of Alzheimer's type according to standardized criteria [ Time Frame: 36 months from baseline ]
    standardized criteria : Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) classifications

  2. Change in CSF and blood amyloid biomarkers of AD [ Time Frame: 24 months from baseline ]
  3. Change in brain atrophy and hippocampal volumes [ Time Frame: 24 months from baseline ]
  4. Progression of small vessels disease markers (white matter lesions, lacunar infarcts, microbleeds) [ Time Frame: 24 months from baseline ]


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants to MEMENTO-Vascod should be included in MEMENTO.
  • To have signed a specific MEMENTO-Vascod informed consent form, prior to any Vascod ancillary study related procedures
  • To be aged 50 years old and above
  • To have a Clinical Dementia Rating scale <0.5 and to be not demented;

Exclusion Criteria:

  • Are under guardianship
  • Live in skilled nursing facility
  • Are Pregnant or breast feeding women
  • Meet brain MRI exclusion criteria (Same criteria as in Memento main protocol)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264899


Contacts
Contact: Geneviève CHENE, Prof. (0)5 57 57 13 92 ext +33 genevieve.chene@isped.u-bordeaux2.fr
Contact: Carole DUFOUIL, Director (0)5 57 57 14 23 ext +33 carole.dufouil@isped.u-bordeaux2.fr

Locations
France
CHU d'Amiens Recruiting
Amiens, France
Contact: Olivier GODEFROY, Prof         
Principal Investigator: Olivier GODEFROY, Prof         
CHU de Bordeaux - Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Jean-François DARTIGUES, Prof         
Principal Investigator: Jean-François DARTIGUES, Prof         
CHU de Dijon Recruiting
Dijon, France
Contact: Olivier ROUAUD, MD         
Principal Investigator: Olivier ROUAUD, MD         
CHU de Lille Recruiting
Lille, France
Contact: Florence PASQUIER, Prof         
Principal Investigator: Florence PASQUIER, Prof         
Hospices civils de Lyon Recruiting
Lyon, France
Contact: Pierre KROLAK-SALMON, Prof         
Principal Investigator: Pierre KROLAK-SALMON, Prof         
AP-HM Recruiting
Marseille, France
Contact: Mathieu CECCALDI, Prof         
Principal Investigator: Mathieu CECCALDI, Prof         
CHU de Montpellier Recruiting
Montpellier, France
Contact: Audrey GABELLE, MD         
Principal Investigator: Audrey GABELLE, MD         
AP-HP - Hôpital BROCA Recruiting
Paris, France
Contact: Olivier HANON, Prof         
Principal Investigator: Olivier HANON, Prof         
AP-HP - Hôpital LARIBOISIERE Recruiting
Paris, France
Contact: Jacques HUGON, Prof         
Principal Investigator: Jacques HUGON, Prof         
CHU de Strasbourg Recruiting
Strasbourg, France
Contact: Frédéric BLANC, MD         
Principal Investigator: Frédéric BLANC, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry for Health and Solidarity, France
Investigators
Principal Investigator: Genevieve CHENE, Prof CIC-EC1401 - ISPED - CHU de Bodeaux
Study Chair: Geneviève CHENE, Prof CIC-EC1401 - ISPED - CHU de Bordeaux
Study Director: Carole DUFOUIL, Director CIC-EC1401 - ISPED - CHU de Bordeaux

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02264899     History of Changes
Other Study ID Numbers: CHUBX 2012/32
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: December 2017

Keywords provided by University Hospital, Bordeaux:
Alzheimer's disease
Mild Cognitive Impairment

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders