Study of Repetitive Behaviors in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Characterize the type of repetitive behaviour (RB) observed in AD and estimate its frequency in this disease
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •I- RB+ (n=42) and RB- (n=30) groups :
- •1 reliable family caregiver identified per patient
- •Patients under legal protection (guardianship/curatorship) or not
- •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 V
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with repetitive behavior (RB+)
Patients without repetitive behavior (RB-)
Control group
Patient with anterograde amnesia (AA)
Patient with anterograde amnesia , resulting from complications following neurosurgery (non-Alzheimer Disease patient).
结局指标
主要结局
Characterize the type of repetitive behaviour (RB) observed in AD and estimate its frequency in this disease
时间窗: 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.
次要结局
- Investigate cognitive characteristics in Alzheimer's disease patients that explain the presence or absence of repetitive behaviour (RB).(At enrollment)
- Investigate the possible link between repetitive behavior and anosognosia.(At enrollment)
研究者
Clément Polin
Principal Investigator
Centre Hospitalier Esquirol