NCT02811653

Brief Summary

In AD (Alzheimer disease), the anatomic correlates of attention disorders (as evaluated by motor slowing) have not been thoroughly characterized.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
155

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

8 years

First QC Date

June 16, 2016

Last Update Submit

March 21, 2023

Conditions

Alzheimer Disease

Keywords

Motor slowing

Outcome Measures

Primary Outcomes (1)

  • median SRT (simple reaction time) to a stimulus (in milliseconds)

    Day 0

Study Arms (2)

Alzheimer disease

EXPERIMENTAL

Alzheimer disease patients Brain MRI (Magnetic Resonance Imaging) Blood neuropsychological evaluation

Device: Brain MRIOther: neuropsychological evaluationBiological: Blood

control

ACTIVE COMPARATOR

Healthy age- and gender-matched volunteers will be recruited into the study from the general population. Brain MRI (Magnetic Resonance Imaging) Blood neuropsychological evaluation

Device: Brain MRIOther: neuropsychological evaluationBiological: Blood

Interventions

Brain MRIDEVICE
Alzheimer diseasecontrol
neuropsychological evaluationOTHER
Alzheimer diseasecontrol
BloodBIOLOGICAL
Alzheimer diseasecontrol

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients
  • Age between 40 and 85
  • French mother tongue
  • Consulting at the Amiens Memory Resource and Research Centre (CMRR) for:
  • MCI, according to Albert et al.'s criteria (Albert et al., 2011)
  • Mild dementia (MMSE\>20) due to AD, according to McKhann's criteria (McKhann et al., 2011).
  • Mild dementia due to LBD, according to McKeith et al.'s criteria (McKeith et al., 2005).
  • Mild dementia due to FTLD, according to Rascovsky et al.'s criteria (Rascovsky et al., 2011).
  • Social security coverage
  • Healthy controls
  • Healthy age and gender matched volunteers will be recruited into the study from the general population.

You may not qualify if:

  • Reading or writing difficulties related to a learning disorder or illiteracy.
  • A medical history with a potentially significant impact on cognition (non-corrected thyroid disorders or heart failure):
  • NYHA stage IV dyspnoea.
  • respiratory impairment requiring oxygen therapy.
  • liver impairment.
  • kidney failure, progressing neoplastic disease, or past or present alcohol abuse.
  • Past or present neurological disorders other than those having prompted consultation in the Memory Clinic:
  • stroke.
  • meningitis or encephalitis.
  • severe head injury.
  • sensorimotor impairments (sensory, proprioceptive, cerebellar and visual impairments).
  • epilepsy (requiring ongoing treatment),
  • psychiatric disorders (other than treated depression).
  • treatment with psychotropic medications (other than anxiolytics or antidepressant withdrawn or initiated in the previous month). Patients with parkinsonian syndrome were examined in the "on-drug" state.
  • Impossibility to perform a neuropsychological evaluation or brain MRI.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Daniela ANDRIUTA, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela ANDRIUTA, PhD

CONTACT

+33 3 22 66 82 40andriuta.daniela@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 23, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

FR(1)