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

26. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Undersøgelsestype

Observationel

Tilmelding (Anslået)

330

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Nancy, Frankrig, 54500
        • CHRU (Centre Hospitalier Régionale Universitaire) Nancy
        • Kontakt:
        • Ledende efterforsker:
          • Thérèse JONVEAUX, Dr

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with Alzheimer disease and their caregivers

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
French version of the QOS Score
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. november 2026

Studieafslutning (Anslået)

1. november 2026

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

26. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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