Recruiting NCT02811653
Motor Slowing and Its Lesion-related Correlates in Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brain MRI, neuropsychological evaluation, Blood.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease. Basic parameters: 40 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
In AD (Alzheimer disease), the anatomic correlates of attention disorders (as evaluated by motor slowing) have not been thoroughly characterized.
Interventions
- Device Brain MRI
- Other neuropsychological evaluation
- Biological Blood
Primary outcome measures
- median SRT (simple reaction time) to a stimulus (in milliseconds) [Time frame: Day 0]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT02811653 · PI2015_843_0003