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Self-consciousness in Dementia

Primary Purpose

Alzheimer Disease, Fronto-temporal Lobar Dementia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnary and IRM
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alzheimer Disease

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • AD (McKhann et al, 1984 and Dubois et al, 2007) or FTLD (Neary et al, 1998 or Rascovsky et al, 2011)
  • MMSE > or = 18
  • Relative avaible

Exclusion Criteria:

  • Contraindication to MRI
  • Major depression
  • Other central neurological condition

Sites / Locations

  • Hôpitaux Universitaires de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Alzheimer disease

Fronto-temporal lobar dementia

Control

Arm Description

Patients with Alzheimer disease

Patients with Fronto-temporal lobar dementia

Control group

Outcomes

Primary Outcome Measures

Characterize the deficit in critical components of personal identity in patients with Alzheimer's disease (AD) and fronto-temporal lobar dementia (FTLD), compared to healthy elderly, combining a neuropsychology and multi-podal neuroimaging study.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2012
Last Updated
September 2, 2020
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT01782248
Brief Title
Self-consciousness in Dementia
Official Title
Self-consciousness in Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 13, 2013 (Actual)
Primary Completion Date
March 12, 2022 (Anticipated)
Study Completion Date
March 12, 2022 (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
The aim of this study is to characterize the deficit in critical components of personal identity (self-consciousness and social cognition) in patients with Alzheimer's disease (AD) and fronto-temporal lobar dementia (FTLD), compared to healthy elderly, combining a neuropsychology and multi-podal neuroimaging study. We posit that the alteration of some aspects of self-consciousness (autobiographical memory, nosognosia, metacognition) and social cognition (theory of mind and facial) results in personality changes in the patients, primarily due to the alteration of self-consciousness in AD and to social cognition in FTLD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Fronto-temporal Lobar Dementia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Alzheimer disease
Arm Type
Other
Arm Description
Patients with Alzheimer disease
Arm Title
Fronto-temporal lobar dementia
Arm Type
Other
Arm Description
Patients with Fronto-temporal lobar dementia
Arm Title
Control
Arm Type
Other
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
Questionnary and IRM
Primary Outcome Measure Information:
Title
Characterize the deficit in critical components of personal identity in patients with Alzheimer's disease (AD) and fronto-temporal lobar dementia (FTLD), compared to healthy elderly, combining a neuropsychology and multi-podal neuroimaging study.
Time Frame
each month for 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: AD (McKhann et al, 1984 and Dubois et al, 2007) or FTLD (Neary et al, 1998 or Rascovsky et al, 2011) MMSE > or = 18 Relative avaible Exclusion Criteria: Contraindication to MRI Major depression Other central neurological condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie PHILIPPI, MD
Phone
3 88 12 86 33
Ext
+33
Email
nathalie.philippi@chru-strasbourg.fr
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie PHILIPPI, MD
Phone
3 88 12 86 33
Ext
+33
Email
nathalie.philippi@chru-strasbourg.fr

12. IPD Sharing Statement

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Self-consciousness in Dementia

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