此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Subjective Assessment of Spatial Orientation Abilities in Alzheimer's Disease (ESCAPE-AD)

2026年5月26日 更新者:Dr Thérèse RIVASSEAU JONVEAUX、Central Hospital, Nancy, France

Evaluation Subjective Des CApacités d'Orientation sPatialE Dans la mAladie D'Alzheimer

Difficulty orienting oneself and finding one's way around the environment, also known as "topographical disorientation" (TD) or "spatial disorientation" (SD), is a common and often early symptom of Alzheimer's disease (AD) that affects people's independence and well-being. Being able to identify it is therefore crucial in order to provide appropriate support.

It cannot be assessed using conventional psychometric tests due to its low ecological validity. Several subjective assessment scales have been created to screen for SD "spatial disorientation" and assess its functional and psychological impact. However, none of these scales have been translated and validated in French. As a result, DS is not assessed in routine clinical practice.

Among these scales, the Wayfinding Questionnaire (WQ) explores three dimensions: spatial orientation, distance estimation, and spatial anxiety. This questionnaire has undergone psychometric validation studies in its original Dutch version for a population with mild post-stroke , and norms for the general population have been published.

Our team translated this questionnaire into French (i.e., "Questionnaire d'Orientation Spatiale" (QOS)) and adapted it cross-culturally to preserve the qualities of the measurement. A "Caregiver" version was also created, taking into account the anosognosia known to occur in AD. Primary Objective : Evaluate the psychometric properties of the Spatial Orientation Questionnaire (SOSQ) (i.e., the French translation and adaptation of the Wayfinding Questionnaire) in assessing spatial orientation disorders in patients with Alzheimer's disease, in both its "patient" and "caregiver" versions. Secondary objective : Evaluate the acceptability of the Spatial Orientation Questionnaire (SOC) in its "patient" and "caregiver" versions.

研究概览

研究类型

观察性的

注册 (估计的)

330

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

      • Nancy、法国、54500
        • CHRU (Centre Hospitalier Régionale Universitaire) Nancy
        • 接触:
        • 首席研究员:
          • Thérèse JONVEAUX, Dr

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

Patients with Alzheimer disease and their caregivers

描述

Inclusion Criteria:

For all subjects :

  • Native French speakers
  • Independent mobility: (minimum mobility range of 3 (i.e., neighborhood) on the LSA-F assessment of the mobility zone scale)
  • Person affiliated with a social security system or beneficiary of such a system

Patients (Subgroup A1) and healthy control subjects (Group C):

  • Individuals who have received complete information about the clinical research organization and have signed their written informed consent
  • Patients (Subgroups A2 and A3) and Companions (Group B) Individuals who have received complete information about the clinical research and have agreed to participate

Patients (group A):

  • Aged 55 to 85
  • Diagnosis of probable Alzheimer's disease (NINCDR-ADRDA diagnostic criteria)
  • Score of 4 or less on the Hachinski Ischemic Scale
  • Score of 20 or higher on the Folstein MMSE (Mini Mental State Examination)
  • In the case of specific treatment for Alzheimer's disease (anticholinesterase and memantine treatments), treatment stability for > 15 days
  • Able to walk independently, i.e., without assistance, whether human or technical, except for a simple cane

Caregivers (group B):

  • Caregivers of a person with dementia included in group A, with regular contact (at least 10 hours per week, spread over a minimum of 3 times per week)
  • Healthy control subjects (group C):
  • Aged 55 to 85
  • Able to walk independently, i.e., without assistance, whether human or technical, except for a single cane
  • Normal performance on the Folstein Mini-Mental State Examination (MMSE), according to GRECO (Cognitive Assessment Task Force) standards

Exclusion Criteria:

For all subjects:

  • Adults subject to legal protection measures (guardianship, curatorship, judicial protection)
  • Adults unable to give their consent
  • Persons deprived of their liberty by judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1.
  • Persons capable of giving consent but unable to read French
  • Persons capable of giving consent but unable to write
  • One of the members of the patient/caregiver dyad refusing to participate in the study.

Patients (subgroup A1) and healthy control subjects (group C):

  • Sensory or phasic deficit interfering with the task.
  • History of moderate or severe head trauma (with loss of consciousness).
  • Change in psychotropic treatment less than 48 hours before the tests
  • Chronic alcoholism
  • Severe depression (score greater than or equal to 10 on the GDS-15 Geriatric Depression Scale)
  • Presence of other clinically significant psychiatric or neurological conditions (except Alzheimer disease for case subjects)

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
干预/治疗
Patients Group
Patients with Alzheimer disease
French version of the wayfinding questionnaire
Accompanying persons
Relatives (friends or family) of patients with alzheimer disease
French version of the wayfinding questionnaire
Control arm
Healthy participants
French version of the wayfinding questionnaire

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
French version of the QOS Score
大体时间:Baseline and between 30 and 90 days after baseline for groups A1, A2, A3, B1 and B2

There are three sub-scores in total :

  • "Navigation and Orientation" sub-score (sum of items 1, 2, 3, 6, 7, 13, 15, 16, 17, 18, 19)
  • "Distance estimation" sub-score (sum of items 4, 5, 14)
  • "Spatial anxiety" subs-core (sum of the reversed scores for items 8, 9, 10, 11, 20, 21, 22, 12)

For these three sub-scores, a high score indicates a good level of spatial orientation.

Baseline and between 30 and 90 days after baseline for groups A1, A2, A3, B1 and B2

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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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 (估计的)

2026年5月1日

初级完成 (估计的)

2026年11月1日

研究完成 (估计的)

2026年11月1日

研究注册日期

首次提交

2026年5月4日

首先提交符合 QC 标准的

2026年5月26日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年5月26日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2019PI271
  • N°ID-RCB : 2025-A00441-48 (其他标识符:ANSM (The National Agency for Drug and Health Product Safety))

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅