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

Not Applicable

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Diagnostic Test: cognitive assessment; Other: working memory; Other: Inhibition evaluation; Other: episodic memory; Other: Assessment of mental flexibility; Other: Evaluation of the update

• Registration Number: NCT03991624
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Study Start: 2019-09-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control (lack of executive functions)	cognitive assessment	-
Alzheimer's patients (lack of executive functions)	cognitive assessment	-
Alzheimer's patients (lack of executive functions)	Assessment of mental flexibility	-
Alzheimer's patients (lack of working memory)	working memory	-
Alzheimer's patients (lack of executive functions)	Inhibition evaluation	-
Alzheimer's patients (lack of executive functions)	Evaluation of the update	-
Alzheimer's patients (lack of working memory)	cognitive assessment	-
control (lack of working memory)	cognitive assessment	-
control (lack of executive functions)	Assessment of mental flexibility	-
Alzheimer's patients (lack of episodic memory)	episodic memory	-
control (lack of episodic memory)	cognitive assessment	-
control (lack of episodic memory)	episodic memory	-
control (lack of executive functions)	Inhibition evaluation	-
control (lack of executive functions)	Evaluation of the update	-
control (lack of working memory)	working memory	-
Alzheimer's patients (lack of episodic memory)	cognitive assessment	-

Primary Outcome Measures

Name	Time	Method
Score obtained (the number of correct answers) by participants in tasks evaluating decision-making	day 14	measured with two decision-making tasks : Iowa Gambling Task and one experimental task

Secondary Outcome Measures

Name	Time	Method
Score obtained in task evaluating working memory	day 14	measured with the continuous operation task.
Scores obtained in tasks evaluating episodic memory	day 14	measured with a recognition task with a Remember/Know paradigm
Scores obtained from the quality of life questionnaire.	day 14	measured with Quality of Life in Alzheimer's Disease : it is composed of 13 items (ex: physical health, memory, relationship with friends...). the patient must rate according to 4 possibilities: bad, fairly good, good or excellent. There is one copy to be completed by the patient and another by the caregiver.
Scores obtained from autonomy questionnaire.	day 14	measured with Direct Assessment of Functional Status : assessment of several areas of daily life (spatial and temporal orientation, communication skills, driving, financial management, shopping ability, behaviour food and hygiene). It consists of 7 subscales, allowing each competency to be assessed independently.
Score obtained in task evaluating executive functions	day 14	measured with an update span task and a n-back task.

Trial Locations

Locations (4)

Hôpital Lariboisière- Fernand Widal; 🇫🇷 Paris, France

Laboratoire d'Etude des Mécanismes Cognitifs; 🇫🇷 Bron, France

CHU de Saint Etienne; 🇫🇷 Saint-Étienne, France

CMRR - Hôpital Charpennes; 🇫🇷 Villeurbanne, France