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NCT Number: NCT07732842

Study of Repetitive Behaviors in Alzheimer's Disease

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.

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Key information

Conditions

Alzheimer Disease Agnosia Amnesia Amnesia, Anterograde Anosognosia Anterograde Amnesia Brain Diseases Central Nervous System Diseases Dementia Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Esquirol Hospital Center

Limoges, New Aquitaine, 87025, France

Location status: Recruiting

Location contact

Alexandra FOUCHER, University degree

CONTACT

[email protected]

555431100 ext. +33

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

I- RB+ (n=42) and RB- (n=30) groups :

  • MMSE > 20
  • 1 reliable family caregiver identified per patient
  • Patients under legal protection (guardianship/curatorship) or not
  • 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)

  • Healthy subjects
  • MMSE ≥ 26/30
  • Men and women matched to AD patients in terms of age and sociocultural level.
  • Healthy subjects will be included by the CMRR in Limoges

III- Control group: Patient with anterograde amnesia (AA) (n=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.
  • This patient is under legal protection (guardianship).
  • Patient monitored and included at the CMRR in Limoges.

Exclusion criteria

I- RB+ and RB- groups and healthy subjects:

  • 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.

Treatment and study plan

Primary outcomes

  1. Characterize the type of repetitive behaviour (RB) observed in AD and estimate its frequency in this disease

    Time frame: At enrollment

    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.

Secondary outcomes

  1. Investigate cognitive characteristics in Alzheimer's disease patients that explain the presence or absence of repetitive behaviour (RB).

    Time frame: At enrollment

    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.

  2. Investigate the possible link between repetitive behavior and anosognosia.

    Time frame: At enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clément POLIN, PhD neuropsychology

CONTACT

[email protected]

555431215 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Esquirol

Other

Registry information

Acronym: ECRA

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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