Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences
MAPdP
2 other identifiers
interventional
180
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable alzheimer-disease
Started Sep 2019
Longer than P75 for not_applicable alzheimer-disease
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2019
CompletedFirst Posted
Study publicly available on registry
June 19, 2019
CompletedStudy Start
First participant enrolled
September 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedApril 29, 2025
April 1, 2025
6 years
February 25, 2019
April 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Score obtained in task evaluating executive functions
day 14
Score obtained in task evaluating executive functions
day 14
Score obtained in task evaluating executive functions
day 14
Score obtained in task evaluating executive functions
day 14
Score obtained in task evaluating executive functions
day 14
- +6 more secondary outcomes
Study Arms (6)
Alzheimer's patients (lack of executive functions)
OTHERcontrol (lack of executive functions)
OTHERAlzheimer's patients (lack of working memory)
OTHERcontrol (lack of working memory)
OTHERAlzheimer's patients (lack of episodic memory)
OTHERcontrol (lack of episodic memory)
OTHERInterventions
* 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
* 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).
* 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.
* 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.
* 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.
\- A recognition task with a Remember/Know paradigm
Eligibility Criteria
You may qualify if:
- Mini-Mental State Examination \> 23
- stable treatment for at least two months
- mother tongue : French
- general cognitive level in the standard on the following tests : Mini-Mental State Examination and Fast Front End Efficiency Battery
- mother tongue : French
You may not qualify if:
- game addiction
- uncorrected visual and hearing disorders
- other neurological or psychiatric history
- inability to communicate
- delusional or psychotic state
- game addiction
- psychiatric or neurological disorders
- anxiety and depression symptomatology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Laboratoire d'Etude des Mécanismes Cognitifs
Bron, 69676, France
Hôpital Lariboisière- Fernand Widal
Paris, 75010, France
CHU de Saint Etienne
Saint-Etienne, 42055, France
CMRR - Hôpital Charpennes
Villeurbanne, 69100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Céline BORG
CHU de Saint Etienne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2019
First Posted
June 19, 2019
Study Start
September 27, 2019
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
April 29, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share