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

Primary Purpose

Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Brain MRI
neuropsychological evaluation
Blood
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer Disease focused on measuring Motor slowing

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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    • treatment with psychotropic medications (other than anxiolytics or antidepressant withdrawn or initiated in the previous month).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.

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alzheimer disease

control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 16, 2016
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT02811653
Brief Title
Motor Slowing and Its Lesion-related Correlates in Alzheimer's Disease
Acronym
TAMA
Official Title
Motor Slowing and Its Lesion-related Correlates in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Motor slowing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alzheimer disease
Arm Type
Experimental
Arm Description
Alzheimer disease patients Brain MRI (Magnetic Resonance Imaging) Blood neuropsychological evaluation
Arm Title
control
Arm Type
Active Comparator
Arm Description
Healthy age- and gender-matched volunteers will be recruited into the study from the general population. Brain MRI (Magnetic Resonance Imaging) Blood neuropsychological evaluation
Intervention Type
Device
Intervention Name(s)
Brain MRI
Intervention Type
Other
Intervention Name(s)
neuropsychological evaluation
Intervention Type
Biological
Intervention Name(s)
Blood
Primary Outcome Measure Information:
Title
median SRT (simple reaction time) to a stimulus (in milliseconds)
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela ANDRIUTA, PhD
Phone
+33 3 22 66 82 40
Email
andriuta.daniela@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela ANDRIUTA, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela ANDRIUTA, PhD
Phone
+33 3 22 66 82 40
Email
andriuta.daniela@chu-amiens.fr

12. IPD Sharing Statement

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

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