NCT01782248

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

March 13, 2013

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2022

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

9 years

First QC Date

October 15, 2012

Last Update Submit

September 2, 2020

Conditions

Alzheimer DiseaseFronto-temporal Lobar Dementia

Outcome Measures

Primary Outcomes (1)

  • 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.

    each month for 3 month

Study Arms (3)

Alzheimer disease

OTHER

Patients with Alzheimer disease

Other: Questionnary and IRM

Fronto-temporal lobar dementia

OTHER

Patients with Fronto-temporal lobar dementia

Other: Questionnary and IRM

Control

OTHER

Control group

Other: Questionnary and IRM

Interventions

Questionnary and IRMOTHER
Alzheimer diseaseControlFronto-temporal lobar dementia

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Nathalie PHILIPPI, MD

CONTACT

3 88 12 86 33nathalie.philippi@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2012

First Posted

February 1, 2013

Study Start

March 13, 2013

Primary Completion

March 12, 2022

Study Completion

March 12, 2022

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations

FR(1)