NCT07616063 · NOT YET RECRUITING

Subjective Assessment of Spatial Orientation Abilities in Alzheimer's Disease

This French study is testing a questionnaire, not a drug or treatment. It checks whether a French version of the Wayfinding Questionnaire reliably measures getting lost and trouble finding one's way in people with Alzheimer's, using patient and caregiver versions. Phase is not specified. It is a measurement study, not a test of any therapy.

Eligibility criteria

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)

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-05-29

View full record on ClinicalTrials.gov

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