- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07826975
Assessment of Changes in Autonomy Through Analysis of Smartphone Usage Data in Patients With Alzheimer's Disease (AUMASMART)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Adrien JULIAN, MD
- Phone Number: +33 05.49.44.44.44
- Email: adrien.julian@chu-poitiers.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Alzheimer's patients
|
Collection of Android smartphone usage
MMSE, FCSRT, FAB, TMT, verbal fluency test, Rey figure, BBEP, langage assesments and HAD scale
IADL Amsterdam assessed by the caregiver
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of changes in smartphone usage data and battery life collected at 0 and 18 months
Time Frame: From enrollment to the end of participation at 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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Céline ABONNEAU, Poitiers University Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neurocognitive Disorders
- Dementia
- Tauopathies
- Neurodegenerative Diseases
- Alzheimer Disease
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Data Collection
Other Study ID Numbers
- 2025-A01157-42
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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