NCT07732842 Study of Repetitive Behaviors in Alzheimer's Disease
| NCT ID | NCT07732842 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Esquirol |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 103 participants |
| Start Date | 2021-06-24 |
| Primary Completion | 2027-02-24 |
Eligibility & Interventions
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 103 participants in total. It began in 2021-06-24 with a primary completion date of 2027-02-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Alzheimer's disease (AD) is characterized by anterograde amnesia, the inability to memorize and remember events occurring after the cerebral lesion. Among the most frequently reported psychobehavioral symptoms are repetitive behaviors (RBs), defined as actions or statements repeated in an inappropriate and non-functional way. The most commonly used tool to assess repetitive behaviors is the Stereotypy Rating Inventory (SRI). It is a questionnaire that evaluates five types of stereotypical behavior: eating, wandering, speech, movements, and daily routines. The frequency and severity of the behaviors are reported, and a total score can be calculated. There is no consensus on the types of repetitive behaviors observed specifically in AD, their frequency, or their cognitive correlates, nor is there a hypothesis explaining why these symptoms do not occur in all AD patients. Furthermore, certain parameters, such as anosognosia (lack of awareness of the disorders), have not been linked to RBs in the literature. We propose to evaluate patients with anterograde amnesia in terms of cognition and behavior-specifically, the presence or absence of both RBs and anosognosia-to examine possible links between cognitive performance, anosognosia, and RB. Moreover, there is no theoretical framework explaining the emergence of RBs in amnesia. We suggest that RBs are linked to a lack of memory updating in the cognitive system. Since episodic memory no longer provides mnemonic feedback, previously encountered stimuli may trigger repeated behavior. To test this hypothesis, we decided to conduct a multicenter, cross-sectional, case-control study. Patients with AD, with or without RBs, as well as healthy subjects, were repeatedly presented with sentence starters to complete freely, with the aim of studying the similarity of responses across sessions for each participant. We also included a patient with pure anterograde amnesia from a previously submitted case study protocol, who exhibited pronounced RBs symptomatology following neurosurgery (non-AD patient), to examine the phenomenon in a non-Alzheimer's context.
Eligibility Criteria
Inclusion Criteria: I- RB+ (n=42) and RB- (n=30) groups : 1. MMSE \> 20 2. 1 reliable family caregiver identified per patient 3. Patients under legal protection (guardianship/curatorship) or not 4. Selection: 4.a. AD patients with an SRI score \> 0 will constitute the RB+ subgroup. 4.b. Only the first 30 patients included will undergo V2, V3, and V4. The first 30 AD patients included with an SRI score = 0 will constitute the RB- subgroup. II- Control group: healthy subjects (n=30) 1. Healthy subjects 2. MMSE ≥ 26/30 3. Men and women matched to AD patients in terms of age and sociocultural level. 4. Healthy subjects will be included by the CMRR in Limoges III- Control group: Patient with anterograde amnesia (AA) (n=1): 1. The patient with anterograde amnesia is a patient who participated in the ANISAAFORNIX study (another study submitted by the investigator) and is included in this study due to rich RB symptomatology. He is a 54-year-old man with lesions of the fornix following complications from neurosurgery, which led to severe anterograde amnesia. This patient does not have AD. 2. This patient is under legal protection (guardianship). 3. Patient monitored and included at the CMRR in Limoges. Exclusion Criteria: I- RB+ and RB- groups and healthy subjects: 1. Isolated participants (without an identified caregiver) (RB+ and RB- groups) 2. Participants must not have a history of alcohol or other substance dependence in the past 12 months. 3. Participants must not have any other neurological condition (with the exception of patients with AA anterograde amnesia). Any history of moderate to severe head trauma, stroke, or developmental disorders is a criterion for exclusion.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07732842 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07732842 currently recruiting?
Yes, NCT07732842 is actively recruiting participants. Contact the research team at clement.polin@ch-esquirol-limoges.fr for enrollment information.
Where is the NCT07732842 trial being conducted?
This trial is being conducted at Limoges, France.
Who is sponsoring the NCT07732842 clinical trial?
NCT07732842 is sponsored by Centre Hospitalier Esquirol. The trial plans to enroll 103 participants.
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