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

Alzheimer Disease Clinical Trial

— TAMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02811653
• Other study ID #: PI2015_843_0003
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Daniela ANDRIUTA, PhD
• Phone: +33 3 22 66 82 40
• Email: andriuta.daniela[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: December 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• Brain MRI

Other:
• neuropsychological evaluation

Biological:
• Blood

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median SRT (simple reaction time) to a stimulus (in milliseconds)		Day 0