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Self-consciousness in Dementia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
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
  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:


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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782248

Locations
France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67098
Sponsors and Collaborators
University Hospital, Strasbourg, France
  More Information

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
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 09, 2016