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Construction-LBD (Constructional Apraxia in Alzheimer's Disease (AD) and Lewy Body's Dementia (LBD))

Primary Purpose

Alzheimer's Disease, Lewy Body's Dementia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rey figure test
MRI
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Alzheimer's disease or Lewy bodies dementia
  • ≥ 45 years
  • the cognitive impairment is mild to moderate
  • French speaker
  • a caregiver is present
  • An informed consent is signed by the patient and the p.i.

Exclusion Criteria:

  • MRI contraindication
  • Other neurological disease (FTD, brain tumor, vascular disease…)
  • Psychiatric disease (Schizophrenia, major depression, psychotic disorders, melancholia…)
  • Patient who doesn't want to be informed in case of the discovery of an abnormality
  • View or audition deficits, or motor disability which can interfere with the cognitive testing
  • Patient participating to an exclusive protocol or in the period of exclusion
  • Pregnant woman
  • Person under an administrative or legal measure of liberty privation
  • Person under a legal measure of protection or under administrative supervision
  • Person unable to give his consent

Sites / Locations

  • Hôpitaux Universitaires de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Alzheimer's disease (AD)

Lewy body's dementia (LBD)

Arm Description

Rey figure test and MRI

Rey figure test and MRI

Outcomes

Primary Outcome Measures

Score obtained at the Rey figure test with a planning strategy help by LBD patients compared to the score obtained by AD patients.

Secondary Outcome Measures

Full Information

First Posted
October 31, 2013
Last Updated
November 18, 2013
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT01993628
Brief Title
Construction-LBD (Constructional Apraxia in Alzheimer's Disease (AD) and Lewy Body's Dementia (LBD))
Official Title
Constructional Apraxia in Alzheimer's Disease (AD) and Lewy Body's Dementia (LBD)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

5. Study Description

Brief Summary
Alzheimer's disease (AD) and Lewy body's dementia (LBD) are two frequent neurodegenerative pathologies. They differ in their expression, their evolution but share same features which make their diagnosis uneasy. Constructional apraxia has been described in both disease.The underlying mechanisms have been less studied and could be different in AD and LBD. The definition of the constructional apraxia is purely descriptive and few models are inconclusive. It is admitted that drawing tasks involve visuo-perceptive and visuo-spatial abilities, executive functions and working memory as well as purely "constructive" skills. Regarding to different studies, visuo-perceptive abilities are more severely impaired in LBD than in AD and are considered as an early onset sign of the disease. Executive functions deficits are documented in AD and LDB and could contribute to the drawing impairment. It is possible to compensate the planning disorders in giving patient the best strategy to use. If drawing impairment persists, they should result of others mechanisms like visuo-perception, visuo-spatial or constructive deficits. The investigators suggest that giving the best planning strategy will help more AD patients who are supposed to fail in raison of an executive impairment, than the LDB group who is supposed to present visuo-perceptive deficits. An MRI will be proposed to study the cerebral areas involved in constructional apraxia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Lewy Body's Dementia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alzheimer's disease (AD)
Arm Type
Experimental
Arm Description
Rey figure test and MRI
Arm Title
Lewy body's dementia (LBD)
Arm Type
Experimental
Arm Description
Rey figure test and MRI
Intervention Type
Other
Intervention Name(s)
Rey figure test
Intervention Type
Other
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Score obtained at the Rey figure test with a planning strategy help by LBD patients compared to the score obtained by AD patients.
Time Frame
At inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Alzheimer's disease or Lewy bodies dementia ≥ 45 years the cognitive impairment is mild to moderate French speaker a caregiver is present An informed consent is signed by the patient and the p.i. Exclusion Criteria: MRI contraindication Other neurological disease (FTD, brain tumor, vascular disease…) Psychiatric disease (Schizophrenia, major depression, psychotic disorders, melancholia…) Patient who doesn't want to be informed in case of the discovery of an abnormality View or audition deficits, or motor disability which can interfere with the cognitive testing Patient participating to an exclusive protocol or in the period of exclusion Pregnant woman Person under an administrative or legal measure of liberty privation Person under a legal measure of protection or under administrative supervision Person unable to give his consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier DE PETIGNY, Docteur
Phone
3 88 11 56 24
Ext
0033
Email
xavier.depetigny@chru-strasbourg.fr
First Name & Middle Initial & Last Name or Official Title & Degree
PHILLIPPS Clelie, Ingenior
Phone
3 88 12 79 25
Ext
0033
Email
clelie.phillipps@chru-strasbourg.fr
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier De Pétigny, Docteur
Phone
3 88 12 79 25
Ext
0033
Email
xavier.depetigny@chru-strasbourg.fr

12. IPD Sharing Statement

Learn more about this trial

Construction-LBD (Constructional Apraxia in Alzheimer's Disease (AD) and Lewy Body's Dementia (LBD))

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