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

March 21, 2023 updated by: Centre Hospitalier Universitaire, Amiens
In AD (Alzheimer disease), the anatomic correlates of attention disorders (as evaluated by motor slowing) have not been thoroughly characterized.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

155

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alzheimer disease
Alzheimer disease patients Brain MRI (Magnetic Resonance Imaging) Blood neuropsychological evaluation
Other: neuropsychological evaluation
Device: Brain MRI
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
Other: neuropsychological evaluation
Device: Brain MRI
Biological: Blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
median SRT (simple reaction time) to a stimulus (in milliseconds)
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Daniela ANDRIUTA, PhD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2015_843_0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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