Clinical trial
Motor Slowing and Its Lesion-related Correlates in Alzheimer's Disease
Name
PI2015_843_0003
Description
In AD (Alzheimer disease), the anatomic correlates of attention disorders (as evaluated by motor slowing) have not been thoroughly characterized.
Trial arms
Trial start
2015-12-01
Estimated PCD
2023-12-01
Trial end
2023-12-01
Status
Recruiting
Treatment
Brain MRI
Arms:
Alzheimer disease, control
neuropsychological evaluation
Arms:
Alzheimer disease, control
Blood
Arms:
Alzheimer disease, control
Size
155
Primary endpoint
median SRT (simple reaction time) to a stimulus (in milliseconds)
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* treatment with psychotropic medications (other than anxiolytics or antidepressant withdrawn or initiated in the previous month).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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 155, 'type': 'ESTIMATED'}}
Updated at
2023-03-22
1 organization
1 indication
Organization
Centre Hospitalier Universitaire AmiensIndication
Alzheimer's disease