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

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Alzheimer Disease

Treatments: Device: Brain MRI; Other: neuropsychological evaluation; Biological: Blood

Study type: Interventional

Funder types: Other

Identifiers

NCT02811653

PI2015_843_0003

Details and patient eligibility

About

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

Enrollment: 155 estimated patients

Sex: All

Ages: 40 to 85 years old

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  • treatment with psychotropic medications (other than anxiolytics or antidepressant withdrawn or initiated in the previous month).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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 2 patient groups

Alzheimer disease

Experimental group

Description:

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

Treatment:

Biological: Blood

Other: neuropsychological evaluation

Device: Brain MRI

control

Active Comparator group

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

Treatment:

Biological: Blood

Other: neuropsychological evaluation

Device: Brain MRI