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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease (AD) Alzheimer's Disease (AD) Related Disorders | Other: in Memento-VASCOD | Not Applicable |
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
|
- Change in cognitive performances over [ Time Frame: 36 months from baseline ]
- 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 ]

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

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
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 |
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 |
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 |