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

NCT ID: NCT02811653

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Alzheimer disease

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

Group Type EXPERIMENTAL

Brain MRI

Intervention Type DEVICE

neuropsychological evaluation

Intervention Type OTHER

Blood

Intervention Type BIOLOGICAL

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

Group Type ACTIVE_COMPARATOR

Brain MRI

Intervention Type DEVICE

neuropsychological evaluation

Intervention Type OTHER

Blood

Intervention Type BIOLOGICAL

Interventions

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Brain MRI

Intervention Type DEVICE

neuropsychological evaluation

Intervention Type OTHER

Blood

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniela ANDRIUTA, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Daniela ANDRIUTA, PhD

Role: CONTACT

+33 3 22 66 82 40

Facility Contacts

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Daniela ANDRIUTA, PhD

Role: primary

+33 3 22 66 82 40

Other Identifiers

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PI2015_843_0003

Identifier Type: -

Identifier Source: org_study_id

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