NCT07826975

Brief Summary

Alzheimer's disease is the leading cause of dementia worldwide. The first cognitive function to be affected is memory. As the disease progresses, other cognitive systems are affected, leading to a gradual loss of independence for the patient. This loss of independence is at the heart of the psychosocial and medico-economic challenges posed by Alzheimer's disease. Functional independence refers to the patient's ability to perform activities of daily living. The evolution of autonomy varies significantly from one individual to another, and a specific, personalized assessment is necessary in order to offer appropriate care and services. There is a link between patient autonomy and psycho-behavioral disorders. Early identification of loss of autonomy in connection with psycho-behavioral disorders would allow specific treatment to be put in place. The study hypothesis is that there is a link between changes in smartphone data and changes in the independence of patients with AD.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
42mo left

Started Sep 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Sep 2026Mar 2030

First Submitted

Initial submission to the registry

April 10, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

September 18, 2026

Status Verified

August 1, 2026

Enrollment Period

3.5 years

First QC Date

April 10, 2026

Last Update Submit

September 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of changes in smartphone usage data and battery life collected at 0 and 18 months

    To measure the relationship between variations in smartphone usage data-represented as a single parameter created through a mathematical combination-and variations in the Amsterdam IADL questionnaire between 0 and 18 months.

    From enrollment to the end of participation at 18 months

Study Arms (1)

Alzheimer's patients

Other: Data collectionOther: Neuropsychological assesmentOther: Autonomy questionnaire

Interventions

Collection of Android smartphone usage

Alzheimer's patients

MMSE, FCSRT, FAB, TMT, verbal fluency test, Rey figure, BBEP, langage assesments and HAD scale

Alzheimer's patients

IADL Amsterdam assessed by the caregiver

Alzheimer's patients

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving routine care at a memory resource and research center for Alzheimer's disease who own an Android smartphone.

You may qualify if:

  • Age ≥ 60 years
  • Patient consulting on routine care at a memory resource and research center for Alzheimer's disease defined by cognitive memory complaints from the patient or their family and friends, evidence of impaired verbal episodic memory storage in FCSRT defined by a sum of FR values less than 17/48 and a sum of CR values less than 40/48 compared to the patient's age and socio-cultural level and no criteria on other neuropsychological tests, progressive decline over at least 6 months affecting independence, and if a brain MRI, a lumbar puncture, and/or an 18FDG PET scan were performed as part of the patient's routine care, the results must be consistent with a diagnosis of MA.
  • Patient with a smartphone for their exclusive use that is compatible with the installation of the IMASMART application on Android
  • No sensory impairment (vision or hearing impairment) that could compromise the use of a smartphone
  • Absence of major anxiety-depressive disorder defined by a HAD score \> 16
  • Patient an caregiver not objecting to participating in the study

You may not qualify if:

  • Inability to perform the Mini-Mental State Examination or score \< 17
  • Other neurodegenerative disorders
  • Severe, unstable psychiatric disorders
  • Terminal phase of a severe illness
  • Other conditions that may compromise the use of a smartphone
  • Patients with an iPhone
  • MRI evidence of a lesion that may contribute to cognitive impairment (stroke, tumors, etc.)
  • Refusal to install the application
  • People residing in a residential care for senior or any other medical facility
  • Individuals benefiting from enhanced protection, namely individuals deprived of their liberty by judicial or administrative decision, adults under legal protection, and finally, patients in emergency situations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Data Collection

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Céline ABONNEAU

    Poitiers University Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2026

First Posted

September 18, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Last Updated

September 18, 2026

Record last verified: 2026-08