- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02264899
MEMENTO-VAScular COmponents of Dementia (VASCOD)
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amiens, France
- CHU d'Amiens
-
Bordeaux, France, 33000
- CHU de Bordeaux - Pellegrin
-
Dijon, France
- CHU de Dijon
-
Lille, France
- CHU de Lille
-
Lyon, France
- Hospices Civils de Lyon
-
Marseille, France
- AP-HM
-
Montpellier, France
- CHU de Montpellier
-
Paris, France
- AP-HP - Hôpital Lariboisière
-
Paris, France
- AP-HP - Hôpital BROCA
-
Strasbourg, France
- CHU de Strasbourg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alzheimer's disease and related disorders
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in cognitive performances over
Time Frame: 36 months from baseline
|
36 months from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
36 months from baseline
|
Change in CSF and blood amyloid biomarkers of AD
Time Frame: 24 months from baseline
|
24 months from baseline
|
|
Change in brain atrophy and hippocampal volumes
Time Frame: 24 months from baseline
|
24 months from baseline
|
|
Progression of small vessels disease markers (white matter lesions, lacunar infarcts, microbleeds)
Time Frame: 24 months from baseline
|
24 months from baseline
|
Collaborators and Investigators
Sponsor
Collaborators
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2012/32
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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