NCT06824142 Feasibility and Interest of the 3D Ephemeris for Temporal Orientation in Alzheimer's: Pilot Study
| NCT ID | NCT06824142 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-04-25 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-04-25 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In geriatric care, occupational therapists use validated tools to assess abilities and performance, identifying deficiencies and proposing rehabilitation programs. Temporal orientation disorders are common, with studies showing that individuals who make mistakes in identifying time are at higher risk of dementia. Temporal orientation issues typically precede spatial orientation problems in Alzheimer's, especially in hospital settings where environmental cues are lost. Maintaining temporal orientation during hospitalization is crucial. While no effective rehabilitation tool currently exists, a new prototype has been developed to address temporal orientation disorders in Alzheimer's and dementia patients, with plans for further evaluation. Main Objective Evaluate in real-life conditions the effectiveness of an adapted external aid, such as the Ephéméride 3D tool, in improving temporal orientation rehabilitation for individuals with Alzheimer's disease or related dementias in the mild to moderate stages. Secondary Objectives Assess the feasibility of establishing a routine with hospitalized patients. Gather feedback from patients, their families, and healthcare professionals regarding the external aid (usefulness, practicality, and aesthetics) as a prototype. Evaluate the desire to continue using the tool once patients return home. Count the number of ephémérides deemed appropriate based on positive feedback from patients, families, and healthcare professionals. This figure is valuable for the company that may decide to scale up the product development. It will be calculated from the results of the attached questionnaires. Method This is a monocentric pilot observational study with data collection based on the following steps: Day 5 (D5): Initial MMSE by the patient's physician. Prescription of temporal rehabilitation. Day 6 (D6): Obtaining consent from the patient and their caregiver. Days 6 to 10 (D6 to D10): Daily assessment of the patient's knowledge of the season, year, month, day of the month (date), and day of the week without external aid (E3D). Days 11 to 15 (D11 to D15): Daily assessment with external aid (E3D) for the same temporal knowledge. Day 16 (D16): Interim and partial MMSE by the patient's physician. Days 17 to 21 (D17 to D21): Daily assessment without external aid (E3D). Days 22 to 26 (D22 to D26): Daily assessment with external aid (E3D). Day 27 (D27): Final and complete MMSE by the patient's physician. Days 28 to 30 (D28 to D30): Questionnaires for the patient, their caregiver, and healthcare professionals (including the study referent in the hospital). 20 patients will be included over a 1-year and 30-day period. Descriptive statistical analyses will be conducted to document patient characteristics at admission and the evolution of key parameters over time (D0 to D30). Paired statistical tests (T-tests/Chi-square) will be performed to identify significant changes between visit times. Longitudinal analyses using mixed-effects linear regression models will assess trends over time, accounting for correlations between repeated measures and evaluating differences based on the use of external aids. Conclusion This observational study primarily aims to describe the feasibility and benefits of using the Ephéméride 3D tool to support temporal orientation rehabilitation in individuals with mild to moderate dementia.
Eligibility Criteria
Inclusion Criteria: * Patient ≥ 65 years old. * Patient presenting with temporal orientation impairment during the MMSE test. * Patient with an MMSE score above 20 (mild stage) or a score between 10 and 20 (moderate stage). * Patient who has not expressed any objection. Exclusion Criteria: * Presence of one or more disruptive behavioral disorders. * Presence of confusion of unknown origin. * Visual blindness. * Inability to read or understand French.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06824142 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06824142 currently recruiting?
Yes, NCT06824142 is actively recruiting participants. Contact the research team at gwenaelle.rebours@aphp.fr for enrollment information.
Where is the NCT06824142 trial being conducted?
This trial is being conducted at Champcueil, France.
Who is sponsoring the NCT06824142 clinical trial?
NCT06824142 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 20 participants.
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