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Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences (MAPdP)

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Enrolling

Conditions

Alzheimer Disease

Treatments

Other: Evaluation of the update
Other: Assessment of mental flexibility
Other: working memory
Other: Inhibition evaluation
Diagnostic Test: cognitive assessment
Other: episodic memory

Study type

Interventional

Funder types

Other

Identifiers

NCT03991624
2019-A00174-53 (Other Identifier)
18CH237

Details and patient eligibility

About

Early in its development, Alzheimer's disease causes not only brain damage affecting different regions of the brain, such as the entorhinal cortex, the anterior cingulate cortex, and the prefrontal lobe, but also a cognitive deficit affecting several functions, such as episodic memory, executive functions, or working memory. Although these different areas and functions are involved in the decision-making process, few studies have focused their research on this subject in the context of Alzheimer's disease. However, a 2008 study showed an early decline in decision-making skills in the disease, but did not link this deficit to cognitive impairment. In addition, decision-making is generally assessed using a test called the Iowa Gambling Task (IGT), which, despite its many advantages, does not have established ecological validity.

In the context of pathology, however, it seems essential to evaluate decision-making in relation to daily life, especially since a deficit in this process would have considerable repercussions on quality of life.

In this study, the investigators seek to better define the disorder by decision-making in early Alzheimer's disease, to understand the links between them with the deficit of other cognitive functions, and to highlight the the consequences that this decline has on patients' daily lives.

Enrollment

180 estimated patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for patients with Alzheimer's disease :

  • Mini-Mental State Examination > 23
  • stable treatment for at least two months
  • mother tongue : French

Inclusion Criteria for control :

  • general cognitive level in the standard on the following tests : Mini-Mental State Examination and Fast Front End Efficiency Battery
  • mother tongue : French

Exclusion Criteria for patients with Alzheimer's disease :

  • game addiction
  • uncorrected visual and hearing disorders
  • other neurological or psychiatric history
  • inability to communicate
  • delusional or psychotic state

Exclusion Criteria for control :

  • game addiction
  • psychiatric or neurological disorders
  • anxiety and depression symptomatology

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 6 patient groups

Alzheimer's patients (lack of executive functions)
Other group
Treatment:
Diagnostic Test: cognitive assessment
Other: Inhibition evaluation
Other: Assessment of mental flexibility
Other: Evaluation of the update
control (lack of executive functions)
Other group
Treatment:
Diagnostic Test: cognitive assessment
Other: Inhibition evaluation
Other: Assessment of mental flexibility
Other: Evaluation of the update
Alzheimer's patients (lack of working memory)
Other group
Treatment:
Diagnostic Test: cognitive assessment
Other: working memory
control (lack of working memory)
Other group
Treatment:
Diagnostic Test: cognitive assessment
Other: working memory
Alzheimer's patients (lack of episodic memory)
Other group
Treatment:
Other: episodic memory
Diagnostic Test: cognitive assessment
control (lack of episodic memory)
Other group
Treatment:
Other: episodic memory
Diagnostic Test: cognitive assessment

Trial contacts and locations

4

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Central trial contact

Céline BORG

Data sourced from clinicaltrials.gov

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