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MEMENTO-VAScular COmponents of Dementia (VASCOD)

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ClinicalTrials.gov Identifier: NCT02264899
Recruitment Status : Unknown
Verified November 2019 by University Hospital, Bordeaux.
Recruitment status was:  Active, not recruiting
First Posted : October 15, 2014
Last Update Posted : November 6, 2019
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


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, Older Adult)
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


Locations
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France
CHU d'Amiens
Amiens, France
CHU de Bordeaux - Pellegrin
Bordeaux, France, 33000
CHU de Dijon
Dijon, France
CHU de Lille
Lille, France
Hospices civils de Lyon
Lyon, France
AP-HM
Marseille, France
CHU de Montpellier
Montpellier, France
AP-HP - Hôpital BROCA
Paris, France
AP-HP - Hôpital LARIBOISIERE
Paris, France
CHU de Strasbourg
Strasbourg, France
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry for Health and Solidarity, France
Investigators
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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
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02264899    
Other Study ID Numbers: CHUBX 2012/32
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Keywords provided by University Hospital, Bordeaux:
Alzheimer's disease
Mild Cognitive Impairment
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders