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

2026年9月7日 更新者: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.

研究概览

地位

招聘中

研究类型

观察性的

注册 (估计的)

103

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
控制组
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-)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Characterize the type of repetitive behaviour (RB) observed in AD and estimate its frequency in this disease
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Investigate cognitive characteristics in Alzheimer's disease patients that explain the presence or absence of repetitive behaviour (RB).
大体时间: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.
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年6月24日

初级完成 (估计的)

2027年2月24日

研究完成 (估计的)

2027年2月24日

研究注册日期

首次提交

2026年7月23日

首先提交符合 QC 标准的

2026年7月23日

首次发布 (实际的)

2026年7月29日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月7日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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