Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences
NCT ID: NCT03991624
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2019-09-27
2025-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Alzheimer's patients (lack of executive functions)
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
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.
control (lack of executive functions)
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
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.
Alzheimer's patients (lack of working memory)
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
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.
control (lack of working memory)
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
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.
Alzheimer's patients (lack of episodic memory)
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
episodic memory
\- A recognition task with a Remember/Know paradigm
control (lack of episodic memory)
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
episodic memory
\- A recognition task with a Remember/Know paradigm
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
60 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Céline BORG
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint Etienne
Locations
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Laboratoire d'Etude des Mécanismes Cognitifs
Bron, , France
Hôpital Lariboisière- Fernand Widal
Paris, , France
CHU de Saint Etienne
Saint-Etienne, , France
CMRR - Hôpital Charpennes
Villeurbanne, , France
Countries
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Central Contacts
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Facility Contacts
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Claire PAQUET
Role: primary
Isabelle ROUCH, MD
Role: primary
Other Identifiers
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2019-A00174-53
Identifier Type: OTHER
Identifier Source: secondary_id
18CH237
Identifier Type: -
Identifier Source: org_study_id
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