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Self-consciousness in Dementia

This study is not yet open for participant recruitment.
Verified January 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01782248
First received: October 15, 2012
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Fronto-temporal Lobar Dementia
 Other: Questionnary and IRM
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Self-consciousness in Dementia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:

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. [ Time Frame: each month for 3 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: February 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Alzheimer disease
Patients with Alzheimer disease
 Other: Questionnary and IRM
Fronto-temporal lobar dementia
Patients with Fronto-temporal lobar dementia
 Other: Questionnary and IRM
Control
Control group
 Other: Questionnary and IRM

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782248

Contacts
Contact: Nathalie PHILIPPI, MD 3 88 12 86 33 ext +33 nathalie.philippi@chru-strasbourg.fr

Locations
France
Hôpitaux Universitaires de Strasbourg Not yet recruiting
Strasbourg, France, 67098
Contact: Nathalie PHILIPPI, MD     3 88 12 86 33 ext +33     nathalie.philippi@chru-strasbourg.fr    
Sponsors and Collaborators
University Hospital, Strasbourg, France
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01782248     History of Changes
Other Study ID Numbers: 5289, 5289
Study First Received: October 15, 2012
Last Updated: January 30, 2013
Health Authority: France: Ministry of Health (National Agency for the safety of drugs and Health products)

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013