Alzheimer DiseaseMAPdPNCT03991624
Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences
A study testing cognitive assessment, Inhibition evaluation and Assessment of mental flexibility in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- cognitive assessment, Inhibition evaluation and Assessment of mental flexibility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesFrance
- Study dates
- 27 Sep 2019to 21 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Laboratoire d'Etude des Mécanismes Cognitifs
Bron, 69676
Hôpital Lariboisière- Fernand Widal
Paris, 75010
CHU de Saint Etienne
Saint-Etienne, 42055
CMRR - Hôpital Charpennes
Villeurbanne, 69100
About this study
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.
- Conditions
- Alzheimer Disease
- Being tested
- cognitive assessment, Inhibition evaluation, Assessment of mental flexibility, Evaluation of the update, working memory
- Keywords
- decision making, Iowa Gambling Task
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive assessmentDiagnostic test
- 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 evaluationOther
- 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 flexibilityOther
- 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 updateOther
- 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 memoryOther
- 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 memoryOther
- A recognition task with a Remember/Know paradigm
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's patients (lack of executive functions) | Other | Not described Receives: Diagnostic Test: cognitive assessment; Other: Inhibition evaluation; Other: Assessment of mental flexibility; Other: Evaluation of the update |
| control (lack of executive functions) | Other | Not described Receives: Diagnostic Test: cognitive assessment; Other: Inhibition evaluation; Other: Assessment of mental flexibility; Other: Evaluation of the update |
| Alzheimer's patients (lack of working memory) | Other | Not described Receives: Diagnostic Test: cognitive assessment; Other: working memory |
| control (lack of working memory) | Other | Not described Receives: Diagnostic Test: cognitive assessment; Other: working memory |
| Alzheimer's patients (lack of episodic memory) | Other | Not described Receives: Diagnostic Test: cognitive assessment; Other: episodic memory |
| control (lack of episodic memory) | Other | Not described Receives: Diagnostic Test: cognitive assessment; Other: episodic memory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 14
Secondary outcomes (11)
Score obtained in task evaluating executive functions
measured with Stroop Victoria
Measured: day 14
Score obtained in task evaluating executive functions
measured with Stop Signal on computer
Measured: day 14
Score obtained in task evaluating executive functions
measured with a letter-number pair task
Measured: day 14
Score obtained in task evaluating executive functions
measured with a category change task.
Measured: day 14
Score obtained in task evaluating executive functions
measured with an update span task and a n-back task.
Measured: day 14
Score obtained in task evaluating working memory
measured with the task of empan baba.
Measured: day 14
Score obtained in task evaluating working memory
measured with the task of reading operations.
Measured: day 14
Score obtained in task evaluating working memory
measured with the continuous operation task.
Measured: day 14
Scores obtained in tasks evaluating episodic memory
measured with a recognition task with a Remember/Know paradigm
Measured: day 14
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.
Measured: day 14
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.
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start27 Sep 2019
- Primary completion1 Apr 2021
- Study completion21 Apr 2021
Why it stopped: Challenges in inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline BORG, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991624
- Sponsor's protocol ID
- 18CH237
- Other IDs
- 2019-A00174-53
- Acronym
- MAPdP
- Status last verified
- May 2026
- First submitted
- 25 Feb 2019
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences
- ClinicalTrials.gov ID
- NCT03991624
- Acronym / sponsor ID
- MAPdP / 18CH237
- Conditions
- Alzheimer Disease
- Keywords
- decision making, Iowa Gambling Task
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Challenges in inclusion
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's patients (lack of executive functions) | Other | Diagnostic Test: cognitive assessment, Other: Inhibition evaluation, Other: Assessment of mental flexibility, Other: Evaluation of the update |
| control (lack of executive functions) | Other | Diagnostic Test: cognitive assessment, Other: Inhibition evaluation, Other: Assessment of mental flexibility, Other: Evaluation of the update |
| Alzheimer's patients (lack of working memory) | Other | Diagnostic Test: cognitive assessment, Other: working memory |
| control (lack of working memory) | Other | Diagnostic Test: cognitive assessment, Other: working memory |
| Alzheimer's patients (lack of episodic memory) | Other | Diagnostic Test: cognitive assessment, Other: episodic memory |
| control (lack of episodic memory) | Other | Diagnostic Test: cognitive assessment, Other: episodic memory |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- game addiction
- uncorrected visual and hearing disorders
- other neurological or psychiatric history
- inability to communicate
- delusional or psychotic state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | Alzheimer's patients (lack of episodic memory), Alzheimer's patients (lack of executive functions), Alzheimer's patients (lack of working memory), control (lack of episodic memory), control (lack of executive functions), control (lack of working memory) |
| 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). | Other | Alzheimer's patients (lack of executive functions), control (lack of executive functions) |
| 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. | Other | Alzheimer's patients (lack of executive functions), control (lack of executive functions) |
| 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. | Other | Alzheimer's patients (lack of executive functions), control (lack of executive functions) |
| 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. | Other | Alzheimer's patients (lack of working memory), control (lack of working memory) |
| episodic memory- A recognition task with a Remember/Know paradigm | Other | Alzheimer's patients (lack of episodic memory), control (lack of episodic memory) |
Primary outcome
Score obtained (the number of correct answers) by participants in tasks evaluating decision-making
Time frame: day 14
measured with two decision-making tasks : Iowa Gambling Task and one experimental task
11 secondary outcomes
Score obtained in task evaluating executive functions
Time frame: day 14
Score obtained in task evaluating executive functions
Time frame: day 14
Score obtained in task evaluating executive functions
Time frame: day 14
Score obtained in task evaluating executive functions
Time frame: day 14
Score obtained in task evaluating executive functions
Time frame: day 14
Score obtained in task evaluating working memory
Time frame: day 14
Score obtained in task evaluating working memory
Time frame: day 14
Score obtained in task evaluating working memory
Time frame: day 14
Scores obtained in tasks evaluating episodic memory
Time frame: day 14
Scores obtained from the quality of life questionnaire.
Time frame: day 14
Scores obtained from autonomy questionnaire.
Time frame: day 14
Results and safety
The study was stopped early (reason given: Challenges in inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline BORG principal investigator
CHU de Saint Etienne
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive assessment, Inhibition evaluation and Assessment of mental flexibility in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Challenges in inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score obtained (the number of correct answers) by participants in tasks evaluating decision-making (time frame: day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.