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Motor Slowing and Its Lesion-related Correlates in Alzheimer's Disease (TAMA)

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ClinicalTrials.gov Identifier: NCT02811653
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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

Condition or disease Intervention/treatment Phase
Alzheimer Disease Device: Brain MRI Other: neuropsychological evaluation Biological: Blood Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Motor Slowing and Its Lesion-related Correlates in Alzheimer's Disease
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alzheimer disease
Alzheimer disease patients Brain MRI (Magnetic Resonance Imaging) Blood neuropsychological evaluation
Device: Brain MRI
Other: neuropsychological evaluation
Biological: Blood
Active Comparator: control

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 MRI
Other: neuropsychological evaluation
Biological: Blood



Primary Outcome Measures :
  1. median SRT (simple reaction time) to a stimulus (in milliseconds) [ Time Frame: Day 0 ]


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Withdrawal from the study at any time, if desired.
  • Pregnancy
  • Contra-indication to MRI:

    • nerve stimulators
    • cochlear implants
    • ferromagnetic foreign bodies close to nervous structures in the eye or brain
    • cerebral shunts
    • dental appliances
  • Legal guardianship or incarceration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811653


Contacts
Contact: Daniela ANDRIUTA, PhD +33 3 22 66 82 40 andriuta.daniela@chu-amiens.fr

Locations
France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Daniela ANDRIUTA, PhD    +33 3 22 66 82 40    andriuta.daniela@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Daniela ANDRIUTA, PhD CHU Amiens

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02811653     History of Changes
Other Study ID Numbers: PI2015_843_0003
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Motor slowing

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders