MEMENTO-VAScular COmponents of Dementia

Alzheimer's Disease (AD) Clinical Trial

— VASCOD  

Official title:

MEMENTO-VAScular COmponents of Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02264899
• Other study ID #: CHUBX 2012/32
• Status: Completed
• Phase: N/A
• Start date: November 4, 2014
• Est. completion date: October 29, 2021

Study information

• Verified date: January 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: October 29, 2021
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease (AD)
• Alzheimer's Disease (AD) Related Disorders
• Dementia

Intervention

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

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	CHU de Bordeaux - Pellegrin	Bordeaux
France	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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Ministry for Health and Solidarity, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive performances over		36 months from baseline
Secondary	Progression to clinical dementia of Alzheimer's type according to standardized criteria	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
Secondary	Change in CSF and blood amyloid biomarkers of AD		24 months from baseline
Secondary	Change in brain atrophy and hippocampal volumes		24 months from baseline
Secondary	Progression of small vessels disease markers (white matter lesions, lacunar infarcts, microbleeds)		24 months from baseline