Clinical trial NCT03991624: Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences
Official title: Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: decision making
Iowa Gambling Task
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 180
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Score obtained (the number of correct answers) by participants in tasks evaluating decision-making
timeFrame: day 14
Secondary outcomes:
measure: Score obtained in task evaluating executive functions
timeFrame: day 14
measure: Score obtained in task evaluating executive functions
timeFrame: day 14
measure: Score obtained in task evaluating executive functions
timeFrame: day 14
measure: Score obtained in task evaluating executive functions
timeFrame: day 14
measure: Score obtained in task evaluating executive functions
timeFrame: day 14
measure: Score obtained in task evaluating working memory
timeFrame: day 14
measure: Score obtained in task evaluating working memory
timeFrame: day 14
measure: Score obtained in task evaluating working memory
timeFrame: day 14
measure: Scores obtained in tasks evaluating episodic memory
timeFrame: day 14
measure: Scores obtained from the quality of life questionnaire.
timeFrame: day 14
measure: Scores obtained from autonomy questionnaire.
timeFrame: day 14
Other outcomes:
Locations:
city: Bron
country: France
facility: Laboratoire d'Etude des Mécanismes Cognitifs
city: Paris
country: France
facility: Hôpital Lariboisière- Fernand Widal
city: Saint-Étienne
country: France
facility: CHU de Saint Etienne
city: Villeurbanne
country: France
facility: CMRR - Hôpital Charpennes
Study officials:
affiliation: CHU de Saint Etienne
name: Céline BORG
role: PRINCIPAL_INVESTIGATOR
References: