Feasibility and Interest of the 3D Ephemeris for Temporal Orientation in Alzheimer's: Pilot Study

NCT06824142 | Recruiting

• 1 other identifier: APHP240896
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease; Related dementia; Temporal disorientation; Rehabilitation; Adapted external aid

Outcome Measures

Primary Outcomes (1)

• Evaluation of Temporal Orientation Rehabilitation with the Ephéméride 3D Tool

  This outcome measure assesses the effectiveness of the Ephéméride 3D tool in improving temporal orientation for individuals with Alzheimer's disease or related dementias in the mild to moderate stages. It is based on daily assessments of the patient's knowledge of time-related information, including season, year, month, day of the month (date), and day of the week, both with and without the use of the external aid (E3D)

  30 days

Interventions

Evaluate in real-life conditions the effectiveness of an adapted external aid as a tool to support temporal orientation rehabilitation for individuals with Alzheimer's disease or related dementias in OTHER

Unlike other interventions, the E3D tool combines an intuitive, user-friendly interface with real-time temporal cues, offering a personalized experience designed to improve cognitive engagement. This external aid is aimed at fostering independence and improving daily functioning by providing clear and consistent information on time-related aspects, such as season, month, day of the week, and current date.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ndividuals hospitalized in a geriatric rehabilitation and follow-up care service.

You may qualify if:

• 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.

You may not qualify if:

• Presence of one or more disruptive behavioral disorders.
• Presence of confusion of unknown origin.
• Visual blindness.
• Inability to read or understand French.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Georges Clemenceau

Champcueil, 91750, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Amyloid beta-Protein Precursor

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amyloidogenic Proteins; Amyloid; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Protein Precursors; Protease Nexins; Proteinase Inhibitory Proteins, Secretory

Central Study Contacts

REBOURS Gwénaëlle, Occupational therapist

CONTACT

+331 69 23 21 33; gwenaelle.rebours@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: April 25, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)