Alzheimer's Disease (AD)VASCODNCT02264899
MEMENTO-VAScular COmponents of Dementia
A study testing in Memento-VASCOD in people with Alzheimer's Disease (AD) and Alzheimer's Disease (AD) Related Disorders, run by University Hospital, Bordeaux at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease (AD), Alzheimer's Disease (AD) Related Disorders
- What is being tested?
- in Memento-VASCOD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 10 sitesFrance
- Study dates
- 4 Nov 2014to 29 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU d'Amiens
Amiens
CHU de Bordeaux - Pellegrin
Bordeaux, 33000
CHU de Dijon
Dijon
CHU de Lille
Lille
Hospices civils de Lyon
Lyon
AP-HM
Marseille
CHU de Montpellier
Montpellier
AP-HP - Hôpital BROCA
Paris
AP-HP - Hôpital LARIBOISIERE
Paris
CHU de Strasbourg
Strasbourg
About this study
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.
Read the 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
- Being tested
- in Memento-VASCOD
- Keywords
- Alzheimer's disease, Mild Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in Memento-VASCODOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's disease and related disorders | Experimental | Not described Receives: Other: in Memento-VASCOD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive performances over
Measured: 36 months from baseline
Secondary outcomes (4)
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
Measured: 36 months from baseline
Change in CSF and blood amyloid biomarkers of AD
Measured: 24 months from baseline
Change in brain atrophy and hippocampal volumes
Measured: 24 months from baseline
Progression of small vessels disease markers (white matter lesions, lacunar infarcts, microbleeds)
Measured: 24 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study start4 Nov 2014
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry for Health and Solidarity, France
- Responsible party
- Sponsor
- Investigators
- Genevieve CHENE, Prof, Principal investigator, CIC-EC1401 - ISPED - CHU de BodeauxGeneviève CHENE, Prof, Study chair, CIC-EC1401 - ISPED - CHU de BordeauxCarole DUFOUIL, Director, Study director, CIC-EC1401 - ISPED - CHU de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264899
- Sponsor's protocol ID
- CHUBX 2012/32
- Acronym
- VASCOD
- Status last verified
- Jan 2022
- First submitted
- 1 Oct 2014
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEMENTO-VAScular COmponents of Dementia
- ClinicalTrials.gov ID
- NCT02264899
- Acronym / sponsor ID
- VASCOD / CHUBX 2012/32
- Keywords
- Alzheimer's disease, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry for Health and Solidarity, France
- Study start
- 4 Nov 2014 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease and related disorders | Experimental | Other: in Memento-VASCOD |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Alzheimer's disease and related disorders |
Primary outcome
Change in cognitive performances over
Time frame: 36 months from baseline
4 secondary outcomes
Progression to clinical dementia of Alzheimer's type according to standardized criteria
Time frame: 36 months from baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Genevieve CHENE, Prof principal investigator
CIC-EC1401 - ISPED - CHU de Bodeaux
Geneviève CHENE, Prof study chair
CIC-EC1401 - ISPED - CHU de Bordeaux
Carole DUFOUIL, Director study director
CIC-EC1401 - ISPED - CHU de Bordeaux
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing in Memento-VASCOD in people with Alzheimer's Disease (AD) and Alzheimer's Disease (AD) Related Disorders, run by University Hospital, Bordeaux at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive performances over (time frame: 36 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.