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Study of Repetitive Behaviors in Alzheimer's Disease (ECRA)

7 de setembro de 2026 atualizado por: Clément Polin, Centre Hospitalier Esquirol

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.

Visão geral do estudo

Status

Recrutamento

Condições

Tipo de estudo

Observacional

Inscrição (Estimado)

103

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Grupo de controle
Patient with anterograde amnesia (AA)
Patient with anterograde amnesia , resulting from complications following neurosurgery (non-Alzheimer Disease patient).
Patients with repetitive behavior (RB+)
Patients without repetitive behavior (RB-)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Characterize the type of repetitive behaviour (RB) observed in AD and estimate its frequency in this disease
Prazo: 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.
At enrollment

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Investigate cognitive characteristics in Alzheimer's disease patients that explain the presence or absence of repetitive behaviour (RB).
Prazo: 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.
At enrollment
Investigate the possible link between repetitive behavior and anosognosia.
Prazo: 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.
At enrollment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Centre Hospitalier Esquirol

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

24 de junho de 2021

Conclusão Primária (Estimado)

24 de fevereiro de 2027

Conclusão do estudo (Estimado)

24 de fevereiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

23 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de julho de 2026

Primeira postagem (Real)

29 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2021-A00631-40

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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