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Alzheimer s DiseaseESCAPE-ADNCT07616063

Subjective Assessment of Spatial Orientation Abilities in Alzheimer's Disease

An observational study of Alzheimer s Disease and Spatial Orientation, run by Central Hospital, Nancy, France at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer s Disease, Spatial Orientation
What is being tested?
Questionnaire d'Orientation Spatiale (QOS)
How many people
330 participants
Where
1 siteFrance
Study dates
May 2026to Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with Alzheimer disease and their caregivers

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

EL AKHDAR Hajar, Master Science contact

0383153596

h.elakhdar@chru-nancy.fr

France1 site

  • CHRU (Centre Hospitalier Régionale Universitaire) Nancy

    Nancy, 54500

    Hajar EL AKHDAR, +33 3 83 15 35 96, h.elakhdar@chru-nancy.fr

    Thérèse JONVEAUX, Dr

Other trials in France

About this study

Official title: 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.

Read more

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.

Being tested
Questionnaire d'Orientation Spatiale (QOS)
Keywords
Alzheimer s disease
Medical subject headings
Orientation, Spatial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaire d'Orientation Spatiale (QOS)Diagnostic test

    French version of the wayfinding questionnaire

Study groups in NCT07616063
Study groupRoleWhat they receive
Patients GroupPatients with Alzheimer disease
Receives: Diagnostic Test: Questionnaire d'Orientation Spatiale (QOS)
Accompanying personsRelatives (friends or family) of patients with alzheimer disease
Receives: Diagnostic Test: Questionnaire d'Orientation Spatiale (QOS)
Control armHealthy participants
Receives: Diagnostic Test: Questionnaire d'Orientation Spatiale (QOS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. French version of the QOS Score

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07616063
Sponsor's protocol ID
2019PI271
Other IDs
N°ID-RCB : 2025-A00441-48
Acronym
ESCAPE-AD
Status last verified
May 2026
First submitted
4 May 2026
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec;46(12):1417-32. doi: 10.1016/0895-4356(93)90142-n.

    PubMed 8263569

  • Epstein J, Santo RM, Guillemin F. A review of guidelines for cross-cultural adaptation of questionnaires could not bring out a consensus. J Clin Epidemiol. 2015 Apr;68(4):435-41. doi: 10.1016/j.jclinepi.2014.11.021. Epub 2014 Dec 17.

    PubMed 25698408

  • Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

    PubMed 11124735

  • van der Ham IJM, Claessen MHG. A clinical guide to assessment of navigation impairment: Standardized subjective and objective instruments and normative data. J Clin Exp Neuropsychol. 2022 Sep;44(7):487-498. doi: 10.1080/13803395.2022.2123895. Epub 2022 Sep 21.

    PubMed 36129157

  • de Rooij NK, Claessen MHG, van der Ham IJM, Post MWM, Visser-Meily JMA. The Wayfinding Questionnaire: A clinically useful self-report instrument to identify navigation complaints in stroke patients. Neuropsychol Rehabil. 2019 Aug;29(7):1042-1061. doi: 10.1080/09602011.2017.1347098. Epub 2017 Jul 18.

    PubMed 28720024

  • van der Ham IJ, Kant N, Postma A, Visser-Meily JM. Is navigation ability a problem in mild stroke patients? Insights from self-reported navigation measures. J Rehabil Med. 2013 May;45(5):429-33. doi: 10.2340/16501977-1139.

    PubMed 23615778

  • Claessen MHG, Visser-Meily JMA, de Rooij NK, Postma A, van der Ham IJM. The Wayfinding Questionnaire as a Self-report Screening Instrument for Navigation-related Complaints After Stroke: Internal Validity in Healthy Respondents and Chronic Mild Stroke Patients. Arch Clin Neuropsychol. 2016 Dec 1;31(8):839-854. doi: 10.1093/arclin/acw044.

    PubMed 27506237

  • Hegarty, M., Montello, D. R., Richardson, A. E., Ishikawa, T., & Lovelace, K. (2006). Spatial abilities at different scales : Individual differences in aptitude-test performance and spatial-layout learning. Intelligence, 34(2), 151-176. https://doi.org/10.1016/j.intell.2005.09.005

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer s Disease and Spatial Orientation, run by Central Hospital, Nancy, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact EL AKHDAR Hajar, Master Science (0383153596, h.elakhdar@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

French version of the QOS Score (time frame: Baseline and between 30 and 90 days after baseline for groups A1, A2, A3, B1 and B2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07616063, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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