MEMENTO-VAScular COmponents of Dementia (VASCOD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02264899
Recruitment Status : Recruiting
First Posted : October 15, 2014
Last Update Posted : February 28, 2018
Ministry for Health and Solidarity, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

October 1, 2014
October 15, 2014
February 28, 2018
November 4, 2014
December 2020   (Final data collection date for primary outcome measure)
Change in cognitive performances over [ Time Frame: 36 months from baseline ]
Same as current
Complete list of historical versions of study NCT02264899 on Archive Site
  • 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
  • Change in CSF and blood amyloid biomarkers of AD [ Time Frame: 24 months from baseline ]
  • Change in brain atrophy and hippocampal volumes [ Time Frame: 24 months from baseline ]
  • Progression of small vessels disease markers (white matter lesions, lacunar infarcts, microbleeds) [ Time Frame: 24 months from baseline ]
Same as current
Not Provided
Not Provided
MEMENTO-VAScular COmponents of Dementia
MEMENTO-VAScular COmponents of Dementia
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.

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
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Alzheimer's Disease (AD)
  • Alzheimer's Disease (AD) 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
Experimental: Alzheimer's disease and related disorders
Intervention: Other: in Memento-VASCOD
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2020
December 2020   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
Contact: Geneviève CHENE, Prof. (0)5 57 57 13 92 ext +33
Contact: Carole DUFOUIL, Director (0)5 57 57 14 23 ext +33
CHUBX 2012/32
Not Provided
Not Provided
University Hospital, Bordeaux
University Hospital, Bordeaux
Ministry for Health and Solidarity, France
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
University Hospital, Bordeaux
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP