Alzheimer Disease Clinical Trial
— MAPdPOfficial title:
Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences
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.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | October 2025 |
Est. primary completion date | October 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Laboratoire d'Etude des Mécanismes Cognitifs | Bron | |
France | Hôpital Lariboisière- Fernand Widal | Paris | |
France | CHU de Saint Etienne | Saint-Étienne | |
France | CMRR - Hôpital Charpennes | Villeurbanne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score obtained (the number of correct answers) by participants in tasks evaluating decision-making | measured with two decision-making tasks : Iowa Gambling Task and one experimental task | day 14 | |
Secondary | Score obtained in task evaluating executive functions | measured with Stroop Victoria | day 14 | |
Secondary | Score obtained in task evaluating executive functions | measured with Stop Signal on computer | day 14 | |
Secondary | Score obtained in task evaluating executive functions | measured with a letter-number pair task | day 14 | |
Secondary | Score obtained in task evaluating executive functions | measured with a category change task. | day 14 | |
Secondary | Score obtained in task evaluating executive functions | measured with an update span task and a n-back task. | day 14 | |
Secondary | Score obtained in task evaluating working memory | measured with the task of empan baba. | day 14 | |
Secondary | Score obtained in task evaluating working memory | measured with the task of reading operations. | day 14 | |
Secondary | Score obtained in task evaluating working memory | measured with the continuous operation task. | day 14 | |
Secondary | Scores obtained in tasks evaluating episodic memory | measured with a recognition task with a Remember/Know paradigm | day 14 | |
Secondary | Scores obtained from the quality of life questionnaire. | 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. | day 14 | |
Secondary | Scores obtained from autonomy questionnaire. | 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. | day 14 |
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