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

Alzheimer Disease Clinical Trial

— MAPdP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03991624
• Other study ID #: 18CH237
• Secondary ID: 2019-A00174-53
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Céline BORG
• Phone: 04 77 82 88 82
• Email: celine.borg[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Diagnostic Test:
• cognitive assessment
MMSE : Mini-Mental State Examination 5 words of Dubois Direct Assessment of Functional Status Trail Making Test BREF : Fast Front End Efficiency Battery short battery of praxies Quality of Life in Alzheimer's Disease

Other:
• Inhibition evaluation
Stroop Victoria : This test consists of 3 sheets of 24 items, organized in 6 lines of 4 (points, neutral words or names of colours), from which the subject must identify the ink of the stimuli as quickly and precisely as possible. Stop Signal task on the computer to give a response to the presentation of a target stimulus (Go signal) (e.g. pressing a button when a red circle appears on the screen, but doing nothing when a blue triangle appears), and prevent this response when the stimulus is followed or preceded by a beep (stop signal) (e.g. the appearance of a red circle is immediately preceded or followed by a beep, the subject should not press the button).
• Assessment of mental flexibility
a letter-number pair task. The subject sees 4 blocks of 48 letter-number pairs appear successively on a screen. When the pair appears at the top, the subject must make a parity judgment but when the pair appears at the bottom, the subject must make a consonant / vowel judgment. a category change task, which consists in classifying a word according to one category or another according to a visual clue that appears. The task consists of 4 blocks of 48 stimuli.
• Evaluation of the update
an update span task for which letters appear on a screen sequentially, and subjects must memorize the last three, without knowing the length of the list. The task will consist of 3 tests of training and then 20 tests. After three errors consecutive, the task ends. an n-back task that consists of a sequential presentation of letters, during which the subject must indicate when the stimulus. The task consists of 3 levels, with n = 1, n= 2 or n = 3. For level 1 (with n = 1), the subject must press a button when the same letter appears twice in a row on the screen. This task consists of 75 letters.
• working memory
the empan baba task, which mainly involves maintaining information, and which consists in retaining a series of letters, appearing sequentially on a screen, and whose latency time between two word presentations is required for a secondary task: the repetition of baba syllables. the task of reading operations which consists in recalling operations series of letters whose presentation is interspersed with the reading aloud of simple operations and of their results. the ongoing operational task of recalling a list of letters, the presentation of which is interspersed with operations that are simple to read aloud and to to solve head-on.
• episodic memory
- A recognition task with a Remember/Know paradigm

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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