NCT02264899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
332

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

November 4, 2014

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2021

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

7 years

First QC Date

October 1, 2014

Last Update Submit

January 27, 2022

Conditions

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

Keywords

Alzheimer's diseaseMild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Change in cognitive performances over

    36 months from baseline

Secondary Outcomes (4)

  • Progression to clinical dementia of Alzheimer's type according to standardized criteria

    36 months from baseline

  • Change in CSF and blood amyloid biomarkers of AD

    24 months from baseline

  • Change in brain atrophy and hippocampal volumes

    24 months from baseline

  • Progression of small vessels disease markers (white matter lesions, lacunar infarcts, microbleeds)

    24 months from baseline

Study Arms (1)

Alzheimer's disease and related disorders

EXPERIMENTAL
Other: in Memento-VASCOD

Interventions

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

Alzheimer's disease and related disorders

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • Are under guardianship
  • Live in skilled nursing facility
  • Are Pregnant or breast feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU d'Amiens

Amiens, France

Location

CHU de Bordeaux - Pellegrin

Bordeaux, 33000, France

Location

CHU de Dijon

Dijon, France

Location

CHU de Lille

Lille, France

Location

Hospices civils de Lyon

Lyon, France

Location

AP-HM

Marseille, France

Location

CHU de Montpellier

Montpellier, France

Location

AP-HP - Hôpital BROCA

Paris, France

Location

AP-HP - Hôpital LARIBOISIERE

Paris, France

Location

CHU de Strasbourg

Strasbourg, France

Location

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Genevieve CHENE, Prof

    CIC-EC1401 - ISPED - CHU de Bodeaux

    PRINCIPAL INVESTIGATOR

  • Geneviève CHENE, Prof

    CIC-EC1401 - ISPED - CHU de Bordeaux

    STUDY CHAIR

  • Carole DUFOUIL, Director

    CIC-EC1401 - ISPED - CHU de Bordeaux

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2014

First Posted

October 15, 2014

Study Start

November 4, 2014

Primary Completion

October 29, 2021

Study Completion

October 29, 2021

Last Updated

January 28, 2022

Record last verified: 2022-01

Locations

FR(10)