MEMENTO-VAScular COmponents of Dementia (VASCOD)

Study Description

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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 Design

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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

Arms and Interventions

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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

Outcome Measures

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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 ]

Eligibility Criteria

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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)

Contacts and Locations

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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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT02264899 History of Changes
Other Study ID Numbers:	CHUBX 2012/32
First Posted:	October 15, 2014
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