NCT07616063Toborzás még nem indult

Subjective Assessment of Spatial Orientation Abilities in Alzheimer's Disease

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 29.

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter): Toborzás még nem indult
Vizsgálattípus: Megfigyeléses
Résztvevők száma: 330 (tervezett)
Első benyújtás: 2026. máj. 4.
Kezdés: 2026. máj.
Elsődleges befejezés: 2026. nov.
Fő szponzor: Central Hospital, Nancy, France
Betegségek: Alzheimer-kór
NCT-szám: NCT07616063

Mit vállalsz

Vizsgálat típusa: Megfigyeléses
Tervezett résztvevők: 330
2026. máj. és az elsődleges befejezés (2026. nov.) között
1 helyszín, 1 országban
Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Korábbi kezelés

Persons deprived of their liberty by judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1.

Más betegség

History of moderate or severe head trauma (with loss of consciousness).
Presence of other clinically significant psychiatric or neurological conditions (except Alzheimer disease for case subjects)

Egyéb

For all subjects:
Adults subject to legal protection measures (guardianship, curatorship, judicial protection)
Adults unable to give their consent
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.
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)

Kiket keres a vizsgálat

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

Életkor a regiszterben: 18 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
CHRU (Centre Hospitalier Régionale Universitaire) Nancy Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát	Nancy	Franciaország	Ismeretlen állapot

Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.