Study of Repetitive Behaviors in Alzheimer's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Esquirol
About this trial
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
This trial accepts healthy volunteersQualifiers
MMSE > 20
1 reliable family caregiver identified per patient
Patients under legal protection (guardianship/curatorship) or not
Healthy subjects
Disqualifiers
Isolated participants (without an identified caregiver) (RB+ and RB- groups)
Participants must not have a history of alcohol or other substance dependence in the past 12 months.
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.
Trial population
The study population consists of: * 42 patients RB+ and 30 patients RB- patients recruited at the CMRR in Limoges and Nantes during their follow-up appointments for Alzheimer's disease. * 30 healthy subjects who are caregivers for patients monitored at the CMRR in Limoges. * And the patient with AA anterograde amnesia, who was recruited as part of his follow-up at the CMRR in Limoges for his severe anterograde amnesia caused by brain damage to the fornix pillars following complications from neurosurgery.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
103 Participants
are grouped into 4 trial groupsGroup A: Patients with repetitive behavior (RB+)
Group B: Patients without repetitive behavior (RB-)
Group C: Control group
Group D: Patient with anterograde amnesia (AA)
Trial outcomes
Primary outcomes
1
Characterize the type of repetitive behaviour (RB) observed in AD and estimate its frequency in this disease
The repetitive behavior score is obtained using the Stereotypy Inventory Rating (SRI) scale after the participant has been included in the study. The five types of stereotypical behavioral disturbances: eating behaviors, wandering, speech, movements, and daily rhythms are collected. A score of zero means no repetitive behavior, and a score strictly above 0 means the presence of repetitive behavior.
Time frame
At enrollmentSecondary outcomes
1
Investigate cognitive characteristics in Alzheimer's disease patients that explain the presence or absence of repetitive behaviour (RB).
Cognitive characteristics are based on scores obtained in the RL/RI16 cognitive tests, which assess learning abilities in verbal episodic memory, particularly the processes of encoding, storage, and retrieval. We believe that we will observe a difference of 2 points out of 16 on the "Recognition" subtest of the RL/RI-16 test between SRI-positive subjects and SRI-negative subjects.
Time frame
At enrollment2
Investigate the possible link between repetitive behavior and anosognosia.
Investigate the possible link between repetitive behavior and anosognosia is based on a possible correlation between the scores obtained on the SRI, CDS, and MPR. The CDS allows anosognosia to be assessed independently of the cognitive task. It contains a patient questionnaire and an helper questionnaire, which are compared, and a discrepancy between the two reflects anosognosia. The Memory Performance Ratio (MPR) allows anosognosia to be assessed in a manner consistent with the cognitive task. Using a 5-point Likert scale, participants are asked to rate the quality of their performance. The pre- and post-dictions will be compared to the patient's actual performance, allowing a ratio to be established: the more accurate the participant is in their representation of their own performance, the lower the ratio will be. The further the participant's assessment is from their actual performance, the higher the ratio will be, indicating anosognosia.
Time frame
At enrollmentSponsors and contacts
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Source ClinicalTrials.gov