NCT01993628

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.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

3.1 years

First QC Date

October 31, 2013

Last Update Submit

November 18, 2013

Conditions

Alzheimer's DiseaseLewy Body's Dementia

Outcome Measures

Primary Outcomes (1)

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

    At inclusion

Study Arms (2)

Alzheimer's disease (AD)

EXPERIMENTAL

Rey figure test and MRI

Other: Rey figure testOther: MRI

Lewy body's dementia (LBD)

EXPERIMENTAL

Rey figure test and MRI

Other: Rey figure testOther: MRI

Interventions

Rey figure testOTHER
Alzheimer's disease (AD)Lewy body's dementia (LBD)
MRIOTHER
Alzheimer's disease (AD)Lewy body's dementia (LBD)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Xavier DE PETIGNY, Docteur

CONTACT

3 88 11 56 24xavier.depetigny@chru-strasbourg.fr

PHILLIPPS Clelie, Ingenior

CONTACT

3 88 12 79 25clelie.phillipps@chru-strasbourg.fr

Study Design

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

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 25, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

FR(1)